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Thematic Guidelines Tuberculosis Control April 2007 Human Development Department Japan International Cooperation Agency (JICA)

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Thematic Guidelines

Tuberculosis Control

April 2007

Human Development Department Japan International Cooperation Agency (JICA)

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Preface

Tuberculosis is the leading infectious disease, and it is estimated that approximately eighty billion persons are infected in the world.

Tuberculosis control is one of the foremost priority issues to be addressed in the Millennium Development Goals (MDGs). That is, the goal is to “halt the expansion of TB-infected persons by 2015 and then begin to reverse the incidence.” The Japanese Government announced the Health and Development Initiative (HDI) pertaining to “health and development” with emphasis on contributing to reaching the MDGs in 2005, thereby expressing its commitment to cooperation for TB control. In the past, JICA has rendered cooperation in a number of countries in the area of TB control and successfully produced a steady and noticeable outcome in terms of improving indicators of TB control. TB control is characterized by the facts that there is globally standardized therapy, that hygienic, affordable, and effective treatment is available even in developing countries, and that the measures to prevent the spread of TB are closely associated with the treatment of each patient. Cooperation for TB control is attracting increasing attention from the perspective of human security in that it undoubtedly benefits people. The Thematic Guidelines on TB control have been formulated with the aim that the persons involved in JICA’s activities will be able to take more effective actions in the area of TB control. That is, in the Guidelines, we review the general situation, trend of aid, and the progress of approaches and schemes in TB control and then identify JICA’s comparative advantage gained from past cooperation. At the same time, we hope that you will make efforts to obtain and deepen people’s understanding of JICA’s basic ideas on TB control by disclosing the Thematic Guidelines to the public, for instance, through JICA’s knowledge site.

April 2007

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Table of contents

Preface Overall view of development issues in TB control Overview Chapter 1: Outline of tuberculosis and tuberculosis control ..................................... 1 1 – 1: Prevalence and burden of tuberculosis .......................................................... 1 1 – 2: Disease called tuberculosis............................................................................ 2 1 – 2 – 1: Infection with Mycobacterium tuberculosis and the onset of disease ... 2 1 – 3: Global initiatives for tuberculosis ................................................................. 4 1 – 3 – 1: Global strategies to stop TB .................................................................. 5 1 – 3 – 2: High-burden countries ........................................................................... 6 1 – 3 – 3: Targets to stop TB.................................................................................. 7 1 – 3 – 4: Expansion of DOTS and future prediction of TB ................................. 7 1 – 3 – 5: Declaration of health emergency of TB in Africa ................................. 8

1 – 3 – 6: New strategies from 2006...................................................................... 9 1 – 4: Major international organizations for TB control.......................................... 10

1 – 4 – 1: Stop TB Partnership............................................................................... 10 1 – 4 – 2: The International Union Against Tuberculosis and Lung Diseases

(IUATLD) .............................................................................................. 11 1 – 4 – 3: Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)........ 12 Chapter 2: Approach to tuberculosis ......................................................................... 14 2 – 1: Capacity development for DOTS implementation (Midterm goal 1) ........... 14

2 – 1 – 1: What is DOTS?...................................................................................... 14 2 – 1 – 2: Components of DOTS ........................................................................... 15

(1) Political commitment with increased and sustained financing................... 16 (2) Case detection through quality-assured bacteriology.......................................16 (3) Standardized treatment, with supervision and patient support .........................16 (4) An effective drug supply and management system.................................... 16 (5) Monitoring and evaluation system, and impact measurement ................... 16

2 – 1 – 3: Case detection and monitoring of treatment under DOTS .................... 18 2 – 1 – 4: Characteristics of DOTS ....................................................................... 19 2 – 2: Capacity development for Beyond DOTS implementation for the vulnerable

population (Midterm goal 2) ......................................................................... 20 2 – 2 – 1: Measures of greater importance under Beyond DOTS ......................... 22

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(1) Community DOTS ..................................................................................... 22 (2) Urban DOTS............................................................................................... 23 (3) Public-Private Mix (PPM).......................................................................... 25 (4) TB/HIV (TB/HIV co-infection).................................................................. 25

2 – 2 – 2: Others .................................................................................................... 29 (1) Multidrug-resistant tuberculosis control (DOTS Plus)............................... 29 (2) Childhood tuberculosis............................................................................... 31

2 – 3: To summarize JICA’s past cooperation ......................................................... 32 2 – 3 – 1: Technical cooperation............................................................................ 34

2 – 3 – 2: Cooperation through training, etc.......................................................... 34 2 – 3 – 3: Application of a modified DOTS strategy for each country.................. 35

2 – 3 – 4: Grant aid ................................................................................................ 35 2 – 3 – 5: Collaboration with volunteer projects ................................................... 36 2 – 4: Human security and tuberculosis .................................................................. 36 2 – 5: Gender and tuberculosis ................................................................................ 39 Chapter 3: JICA’s cooperation policy on TB control ................................................ 40 3 – 1: JICA’s cooperation policy on TB control ...................................................... 40

3 – 1 – 1: Give priority to High Burden countries................................................. 40 3 – 1 – 2: Place an emphasis on the strengthening the quality of DOTS .............. 47 3 – 1 – 3: Support the Beyond DOTS strategy...................................................... 47

3 – 2: Notes concerning JICA’s cooperation policy on TB control ......................... 48 3 – 2 – 1: Cooperation primarily for human resource development, institution building

and system building (i.e., capacity development) ................................. 49 3 – 2 –2: Secure the sustainability of the quality maintenance and improvement

entailed in the TB control project .......................................................... 49 3 – 2 – 3: Introduce a system modified for each country through implementing a model

project, etc. ............................................................................................ 49 3 – 2 – 4: Make full use of the advantage of each scheme for effective cooperation .............................................................................................................. . 49 3 – 2 – 5: Cooperation in closer partnership with international organizations and

aid organizations.................................................................................... 50 3 – 3: Issues concerning the execution of JICA’s cooperation policy on TB control 53

3 – 3 – 1: To systematize cooperation programs to meet the needs and conditions of each country........................................................................................... 53

3 – 3 – 2: Development and strengthening of input resources .............................. 56 3 – 3 – 3: To strengthen information collection and transmission

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concerning DOTS.................................................................................. 57 3 – 3 – 4: To strengthen the implementation system to address new challenges... 58

Appendix 1: Major examples of cooperation Appendix 2: Basic check items

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Overall view of development issues in TB control

Goal of development

strategy

Midterm goals Sub-goals under the midterm goals

Examples of project activities

・To formulate TB control guidelines for officials in charge of TB control in the national, provincial, and prefectural administration

・To support training for officials in charge of TB control in the national, provincial, and prefectural administration

・To strengthen the higher organization’s roles of monitoring, evaluation, and supervision of lower organizations

・To improve report system from officials in charge at all levels

・To support coordination with other development agencies

Management capacity development for TB control

・To support collection of information about valid TB control

・To formulate guidelines on sputum smear microscopy

・To formulate a training module ・To support the establishment of an internal

quality assurance system

Development of capacity for microscopic testing

・To support the establishment of an external quality assurance system

・To support the development of the national procurement system of anti-TB drugs

・ To develop the record-keeping and reporting system (TB registry system) at the prefecture level

1. Capacity development for DOTS implementation

Development of capacity for logistics

・To support switch-over to 4FDC Capacity development for the implementation of urban DOTS and hospital DOTS

・To draw up guidelines for intervention with defaulters on treatment and people with a high risk of being infected

・To support the building of collaboration among public organizations, private organizations, and civil organizations

・To prevent hospital-associated infection and to get hospitals involved

Capacity development for the implementation of public-private mix (PPM) in DOTS

・To support the building of collaboration between public organizations and private organizations

・To draw up guidelines for PPM ・ To support the introduction of HIV

antibody testing among TB patients Capacity development for TB/AIDS control ・ To support the strengthening of

collaboration with HIV control

The government of the recipient country (implementing agency) obtains the ability to reach a case detection rate of over 70% and a treatment success rate of over 85%.

2. Capacity development for Beyond DOTS implementation for the vulnerable

・To draw up guidelines for Community DOTS

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・To support the formulation of a training module

Capacity development for rural TB control

・To support reinforcing the development of volunteers for medication confirmation

・To improve the capacity of bacterial culture・To improve drug sensitivity testing ability

Capacity development for multidrug-resistant TB control

・To improve the management capacity of the laboratory

Other Capacity development for tuberculosis in childhood

To support the establishment of a contacts examination system

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Overview Chapter 1: Outline of tuberculosis and tuberculosis control 1 – 1: Prevalence and burden of tuberculosis

Approximately one third of the total population of the world is infected with tuberculosis (or TB). Each year, some nine million new patients1 are added, and approximately two million people die of TB. Serious problems are posed by the facts that its burden is concentrated in developing countries and that the TB infection rate has been expanding in parallel with the expansion and prevalence of the human immunodeficiency virus (or HIV) in sub-Saharan Africa. In fact, effective and feasible TB treatment is available even in developing countries. Thus, it is possible to cure TB completely with affordable therapy. On the other hand, a challenge is that the TB burden is not yet on the decrease due in part to constraints of systems and human resources. 1 – 2: Disease called tuberculosis

TB is an infectious disease in which the person is the source of infection. Its pathogen is Mycobacterium tuberculosis. The onset of tuberculosis, that is, symptoms observed in the TB-infected person (or carrier), is followed by an infection phase of two years on average. It is projected that during this phase, one patient infects from ten to thirteen persons per year. After the onset, half of patients will die after five years unless they are treated properly. A feature of TB is that Mycobacterium tuberculosis goes into dormancy as long as the infected person is in good health, but it recurs when he/she is in ill health. 1 – 3: Global initiatives for tuberculosis

TB control as well as HIV/AIDS control has been intensified in international coordination. Since the 1990s, the World Health Organization (WHO) has been vigorously addressing the issue of TB control: it established global goals; it declared TB a global health emergency; and it formulated a framework of global TB control strategies. TB control is also set as one of the priority issues in the Millennium Development Goals (MDGs) and the Health and Development Initiative (HDI). With respect to specific TB control measures, since the WHO proposed a package of

1 In the Guidelines, a patient is defined as a person who becomes infected with Mycobacterium tuberculosis and

shows its symptoms.

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strategies called Directly Observed 2 Treatment with Short-course Chemotherapy (DOTS3), many countries have adopted measures in order to introduce and diffuse the DOTS strategy. 1– 4: Major international organizations for TB control

The Stop TB Partnership is constituted of WHO, various nations, private aid organizations, and NGOs. The Partnership looks into the problems pertaining to TB control and their solutions and tries to mobilize resources from related organizations. To put it in more concrete terms, for instance, it announced global TB control strategies for the period from 2006 to 2015. Besides, the International Union against Tuberculosis and Lung Diseases (IUATLD) carries out similar activities as one of the chief international aid organizations. The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) also provides aid to the area of tuberculosis. These organizations have been taking actions for TB control under the global cooperation system to achieve the MDGs in a concerted effort. Chapter 2: Approaches to tuberculosis 2 – 1: Capacity development for DOTS implementation (Midterm goal 1)

DOTS means a package of strategies that contain a series of actions to be carried out by executive organs in order to detect, diagnose, and treat contagious TB patients. DOTS originally means treatment in which drugs are administered to patients in front of a medical professional (that is, under direct observation). However, its definition has been broadened and globally used as an abbreviation to connote a package of TB strategies consisting of five components including logistics such as testing reagents and anti-tuberculosis drugs and the development of human resources so that TB treatment can be continued. The DOTS strategy was originally developed based upon the failure of TB control before the 1990s. It is the first TB control strategy whose validity has been established in developing countries. Hence, TB control now follows the DOTS strategy worldwide. In the Thematic Guidelines, which present the cooperation policy of the Japan International Cooperation Agency, three sub-goals are set under the midterm goal as a

2 In the meeting of STOP TB of 2006, a group of patients pointed out that the phrase “direct observation” was inappropriate. Thereafter, the phrase “medication confirmation” has been gradually replacing the former. However, in the Guidelines, the former phrase is used.

3 An interpretation of the term “DOTS” goes beyond its normal definition of “short-term chemotherapy under direct observation.” That is, it is used among people related to TB control as a term that expresses a “strategic package” inclusive of management, microscopy, and logistics.

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result of classifying the output of the Project Design Matrix (PDM) of projects that JICA has implemented in the past and also in reference to the five components of DOTS.4 2 – 2: Capacity development for Beyond DOTS implementation for the vulnerable

population (Midterm goal 2) The DOTS strategy forms the foundation of TB control, and is the globally

standardized approach. Hence, there are cases in which additional different measures need to be undertaken in order to deal with the diverse conditions of each country. In developing countries, there are new needs for implementing a variety of stepped-up actions in addition to the DOTS strategy. This is because a sufficient number of public medical service centers have not been established to cover the entire nation and because HIV has been extensively spreading. For instance, Community DOTS and TB/HIV control, which come under the Beyond DOTS strategy, have been developed and proven effective. It is essential, however, to study carefully before introducing Beyond DOTS whether DOTS, which lies at the heart of TB control, has been properly implemented. 2 – 3: To summarize JICA’s past cooperation JICA has made effective use of various schemes such as project-type technical cooperation and training courses as a package. Furthermore, it has provided aid to strengthen the TB control of each country in close partnership with the United States Agency for International Development (USAID), the World Food Program (WFP), the World Bank (WB), the Asian Development Bank (ADB), and other non-governmental organizations (NGOs). Since the 1990s, JICA has focused upon the application and development of the DOTS strategy in many countries. In particular, JICA has produced excellent results in its cooperation for capacity development including the development of necessary human resources, institutional building, and system building in order to strengthen the abilities of the recipient country to operate and manage DOTS under its national TB control program. 2 – 4: Human Security and tuberculosis

4 In the “Global Plan to Stop TB for 2006-2015” announced in January 2006, Beyond DOTS is explained as a part of

DOTS. It is assumed that this interpretation will be accepted more and more in the future worldwide. On the other hand, the Guidelines have been prepared as reference material for JICA’s staff. Hence, DOTS and Beyond DOTS are separately presented so that the situation can be explained clearly and simply since it is reasonable to consider that DOTS still lies at the heart of TB control.

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Tuberculosis has been placing a heavy burden especially on the poor in developing countries. Hence, cooperation for TB control addresses the issues integral to Human Security, i.e., “freedom from fear” and “freedom from want.” The DOTS strategy is an approach that has translated human security into concrete actions as indicated by the fact that support is directly extended to each patient without fail. On the other hand, the poor often find it difficult to have access to public medical services. As a result, it is often the case that the strengthening of only DOTS that provides TB control services through public medical institutions is insufficient. In order to give due consideration to the poor, actions such as Community DOTS included in Beyond DOTS need to be implemented so as to create an environment in which patients from any social strata have easy access to medical care service. 2 – 5: Gender and tuberculosis

Tuberculosis poses a menace to women. That is, the number of women who die of TB is greater than their deaths related to child delivery. TB is certainly not a disease that inflicts a burden only upon women. However, women are more exposed to the risk of being infected and vulnerable to the quick progress of the disease probably for the following reasons: the environment surrounding women is very disadvantaged in developing countries; more women tend to assume the responsibility of taking care of TB patients at home; and women, in particular, have greater difficulties in access to public medical services. Chapter 3: JICA’s cooperation policy on TB control 3 – 1: JICA’s cooperation policy on TB control JICA’s cooperation policy on TB control consists of the following three pillars: ① To set priority countries (high-burden countries, high-incidence countries, or

countries that lag behind in TB control) Aid priority is given to those countries that suffer from a heavy burden of TB and lag behind in TB control.

② To give overriding priority to the qualitative reinforcement of DOTS In JICA’s cooperation, the highest priority is given to reinforcing the DOTS strategy that is in the hub of TB control, thereby giving a boost to all TB control actions.

③ To assist the Beyond DOTS strategy From the perspectives of Human Security and effective reinforcement¥/ of TB control, JICA shall render necessary support to strengthen “Beyond DOTS” based

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upon the way in which DOTS has been implemented in each country and the conditions peculiar to the country.

JICA will provide these priority countries as stated in ① with cooperation of ② or

③ according to the conditions of each country, or it may give cooperation that contains both components selectively chosen from ② and ③. In other countries than those listed in ①, JICA also has a possibility to carry out activities that partially entail TB control as a part of measures against other diseases including HIV/AIDS or regional public health projects, although projects that principally focus on TB control will not be implemented. Besides, JICA will extend cooperation for developing the general capacity of people involved in TB control in other countries than those listed in ① in such way as group training courses held in Japan. 3 - 2: Notes concerning JICA’s cooperation policy on TB control

JICA will adopt the following five approaches in its cooperation in the area of tuberculosis. JICA regards these approaches to be important to TB control based upon its experience and also the fact that it has a comparative advantage. ① To focus upon capacity development with the chief aims of human resource

development, system building, and institutional building. ② To consider the maintainance or improvement of the quality of TB control program,

and the assurance of the sustainability of the system. ③ To apply a system modified to suit each country through such way as implementing

a model project ④ To provide cooperation in a package of various schemes ⑤ To provide cooperation in closer partnership with other international organizations

and aid organizations. 3 - 3: Issues concerning the execution of JICA’s cooperation policy on TB control JICA focuses upon improving the following three issues: ① To systematize cooperation programs suited to the circumstances of each country ② To improve and strengthen input resources ③ To strengthen the collection and transmission of information

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Chapter 1: Outline of tuberculosis and tuberculosis control

1 – 1: Prevalence and burden of tuberculosis Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. It is the leading disease among infectious diseases caused by a mono-pathogen. The World Health Organization (WHO) estimates that over one third of the world’s population (equivalent to some 1.9 billion persons) has already been infected and that there are about nine million new TB cases and nearly two million TB deaths each year.1 About half of patients die after five years if left untreated. This is essentially a curable disease if it is treated properly. Despite the availability of affordable drugs for its treatment, neither the number of TB patients nor TB deaths have decreased due to various factors.2 Big problems are that the burden of TB has been concentrated in developing countries and the number of TB patients is on the increase particularly in sub-Saharan Africa in parallel with the spread of human immunodeficiency virus (HIV) (as shown in Figure 1-1). More than 95% of TB patients and over 99% of deaths are concentrated in developing countries.3 Factors to quicken the epidemic of TB are variable including poverty, increasing population, social unrest, and gravitation of population towards urban cities. Similarly, approximately 30% of HIV-infected persons die of TB throughout the world. It is reported that the leading cause of death is tuberculosis among HIV-infected persons.4 The dark green parts of Figure 1 – 1 indicate areas where the TB incidence rate is high. That it is concentrated in sub-Saharan Africa is evident from the map.

1 WHO Report 2007: Global Tuberculosis Control Surveillance, Planning, Financing. 2 (Ishikawa, Nobukatsu: How should Japan be involved in the global TB problem? 1999, Vol. 80, No. 2; 89-94, 2005) 3 Dye, C: Global Burden of Tuberculosis, JAMA, 1999; Vol. 282, No. 7 4 Tuberculosis Research Institute: DOTS stories of Three Kingdom : fighting against tuberculosis in developing cou ntries : DOTS strategy and Japan's internatinal cooperation

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Figure 1 – 1: Estimated TB incidence rate by country (2005) Source: WHO Report 2007: Global Tuberculosis Control Surveillance, Planning Financing

1 – 2: Disease called tuberculosis When a person becomes infected with Mycobacterium tuberculosis and develops its symptoms, his/her lungs are corroded with TB over a period of from several months to several years. The tissues of the corroded lungs are discharged out of the body together with M. tuberculosis, which become the source of infection for people in frequent contact with the patient. The TB condition gradually progresses. That is, a respiratory disorder is caused, and mycobacteria invade other parts of the body. In some cases, they destroy brain and internal organs, thereby leading to death. 1 – 2 – 1: Infection with Mycobacterium tuberculosis and the onset of disease (1) Route of transmission

Tuberculosis spreads with aerosol droplets (droplet infection or airborne infection). M. tuberculosis invades the lungs and is discharged together with sputum or mucus. Other persons inhale the bacteria, thereby becoming infected.

(2) Loop of TB infection (Infection, onset of the disease, and spread)

Mycobacterium tuberculosis invades the body, whereby the passive (acquired) immune system goes into action and antibodies are formed. This stage is called

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“being infected.”5 TB infection leads to “full-blown TB” in about 10~20% cases without being naturally cured.

When the active TB disease progresses further, M. tuberculosis is discharged out of the body, thereby infecting other persons around (being in a state of sputum smear positive). This state continues for about two years on average. During this period, one TB-infected person may infect 10~13 other persons on average per year.

TB kills about half of those infected, if not properly treated. Approximately 20% of them continue to discharge M. tuberculosis even after five years, whereas about 30% are naturally cured (sputum smear negative: no M. tuberculosis being found by sputum smear microscopy).6

There are some risk factors that induce the onset of full-blown TB disease from the infection stage. They include diabetes, slender physique, malnourishment, aging, and heavy smoking as well as factors that weaken cellular immunity such as HIV infection and immunosuppressant drug therapy.

5 More specifically, Mycobacterium tuberculosis that has reached the end of the lung tries goes farther into the body. Then, the immunity that is passively triggered begins to function (non-specific immunity by macrophages). If M. tuberculosis defeats this immune system, an order is given to manufacture antibodies from helper/inducer T cells (putting active immunity into action; non-specific immunity). At this phase, it is defined that “the person has been infected with TB.” 6 Aoki, Masakazu: A study of tuberculosis useful for daily treatment and duties; p. 35, April 2002

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Figure 1 – 2: Infection and the onset of disease

1 – 3: Global initiatives for tuberculosis In TB control, there is global collaboration. Under the “Stop TB Initiative” led by the WHO and constituted by national governments, related international organizations, aid organizations and NGOs, the “Stop TB Partnership” has been addressing the issue of TB control and making efforts to funnel aid from countries into TB control. In particular, since 1994, the principal focus has been on the DOTS strategy. In a new strategy paper for the following decade (Global Plan to Stop TB 2006-2015) formulated in 2006, it was proposed to scale up various actions that had been classified under the Beyond DOTS strategy in addition to ensuring the implementation of DOTS. (Refer to 2 – 1: DOTS and 2 – 2: Beyond DOTS in Chapter 2.)

Droplet M. tuberculosis

Droplet nuclei M. tuberculosis

Invasion of M. tuberculosis into the lungs

Attached to the lungs and discharged by ciliary movement

Acquired (cellular) immunity goes into action.

Macrophages

If innate immunity is unable to suppress M. tuberculosis

Infected with M. tuberculosis

Immune system is unable to suppress M. tuberculosis

Primary infection Onset (Active TB) Not manifested

throughout the life Onset from past infection

Immune system suppresses M. tuberculosis

Invasion into the tip of the lungs

Innate immunity goes into action.

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1991 General Assembly of the WHO “to achieve an 85% cure rate and a 70% detection

rate by 2000”

1993 WHO declared “tuberculosis a global emergency.”

It warned that TB had inflicted extensive health damage in many areas of the world

due to the neglect of TB control, the spread of HIV infection, and the emergence of

multidrug-resistant strains of M. tuberculosis.

1994 The WHO announced the Framework for Effective Tuberculosis Control.

1995 The WHO adopted the DOTS strategy.

1996 The 24th of March was made World TB Day .

1998 The Stop TB Partnership was founded (the London Conference).

March 2000 Amsterdam Declaration (Ministerial Conference on Tuberculosis)

July 2000 G8 – Okinawa Infectious Disease Initiative: IDI

October 2000 The WHO stipulated the Millennium Development Goals (MDGs) at the General

Assembly.

2001 The Washington Commitment was adopted (50/50),7 (Stop TB Partners’ Forum)

2002 The Global Fund to Fight AIDS, Tuberculosis and Malaria began assistance.

2005 Health and Development Initiative (HDI) by the Japanese Government

2006 The WHO announced the Global Plan to Stop TB for 2006-2015.

1 – 3 – 1: Global strategies to stop TB TB was neglected over a prolonged period of time in a great number of countries. Even the WHO paid very little attention. As a result, it continues to be the leading killer in developing countries. At the same time, the circumstances of advanced countries have changed as well. That is, they are witnessing a resurgence of TB health damage that was once under control.8 The 44th World Health Assembly of the WHO (1991) set two key global targets to be reached by 2000: 70% of existing (or estimated) acid-fast bacilli smear-positive TB patients will be detected, and 85% of newly detected smear-positive TB patients will complete the course of treatment regimen (to succeed in treatment) so that TB is paid higher attention. In 1993, two years later, the WHO declared TB a public health emergency and

7 The governments of high-burden countries and Stop TB partners came together at the World Bank in Washington and the framework of partnership and the Global Plan to Stop TB were approved. “50/50” indicates that the Forum used 50 as the keyword and set the goals to be achieved within each period of 50 years, 50 months, 50 weeks, and 50 days. 8 The circumstances of advanced countries have changed due to a variety of factors including multidrug-resistant TB cases detected in New York from 1991 to 1993 and an increasing number of HIV/AIDS-associated cases. (Ishikawa, Nobukatsu: World’s TB, Japan’s TB. J. Nippon Med SCH 2000; 67(5)”

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made a recommendation that its member countries should address TB control as the overriding priority issue, because it was found that the damage caused by TB had spread to many areas in the world due to the neglect of TB control, the spread of HIV, and the emergence of multidrug-resistant strains of Mycobacterium tuberculosis (in (1) Community DOTS under Section 2 – 2 – 1 in Chapter 2). Subsequently, the WHO formulated a framework of global strategies in order to develop more effective and potent measures.9 It later grew into a package of strategies called DOTS. DOTS originally means that medication is supervised under direct observation in a short course of chemotherapy. However, currently, DOTS has been transformed into a concept. That is to say, it is now globally used as an acronym to indicate a package of TB control strategies consisting of the following five components on which the WHO lays emphasis as TB control measures in developing countries: ① Political commitment with increased and sustained financing ② Case detection through quality-assured bacteriology ③ Standardized treatment,with supervision and patient support ④ An effective drug supply and management system ⑤ Monitoring and evaluation system,and impact measurement (Chapter 2 discusses the strategies in depth.) Subsequent to the development of DOTS, the WHO made it a policy to seek scientific evidence to prove that DOTS was the most cost effective among various disease control measures and health administrative measures. Based upon the evidence, the WHO raised funds from donors under the initiative adopted by the WHO, etc., thereby expediting the adoption of the DOTS strategy globally. 1 – 3 – 2: High-burden countries In March 1998, the First ad hoc Committee on the Tuberculosis Epidemic was held in London. There, public health experts got together from all over the world and introduced the fact that 80% of estimated TB patients of the world were concentrated in 22 countries. In the same Committee, it was pointed out that the delay in the progress of DOTS in those 22 countries had an adverse effect on the expansion of DOTS in the world. Hence, the 22 countries were regarded as high-burden countries, and it was decided to give top priority to implementing DOTS in these countries (Refer to Table 3-2 (right side) in Chapter 3).

9 WHO: Effective Framework for Tuberculosis Control, 1994

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1 – 3 – 3: Targets to stop TB Despite the efforts to strengthen DOTS, it was difficult to achieve the goals to “reach an 85% treatment success and a 70% case detection rate of TB by 2000.” As a result, the year was put off to 2005. The Stop TB Partnership (an international organization in which all nations and private organizations fight against the crisis of tuberculosis in a concerted effort) was formed subsequent to the abovementioned London Conference. (Section1 – 4 – 1: Stop TB Partnership discusses the issue in detail.) The Partnership announced the “Global Plan to Stop TB 2001-2005” that aimed to achieve these targets by 2005 and halve TB cases by 2010.10 The Millennium Development Goals (MDGs) address the issue of tuberculosis under Target 8 “Halt by 2015 and then begin to reverse the incidence of malaria and other major diseases” in Goal 6 “Combat HIV/AIDS, malaria, and other diseases.” Indicators include “23. Prevalence and death rates associated with tuberculosis” and “24. Proportion of tuberculosis cases detected and cured11 under directly observed treatment short-course DOTS (internationally recommended TB control strategy).”11 The Japanese Government announced the “Health and Development Initiative” (HDI) and its commitment to reaching the targets associated with health in the MDGs.12 1 – 3 – 4: Expansion of DOTS and future predictions of TB As of 2004, 183 countries out of 210 countries have adopted DOTS, and DOTS covers 83% of the world’s population (that is, people living in the regions where DOTS is implemented).13 Nonetheless, there is still a long way before reaching the global targets of achieving “70% case detection and 85% treatment success rates.” The regions where the DOTS strategy has been adopted have reached a treatment success rate of 82% of new sputum smear-positive patients,14 on the other hand, case detection hovered at a low rate of 51% by 2001 and rose to 64% in 2004.15 It is proven that the outcome of TB treatment improves under the DOTS strategy, but the WHO Report 2006 maintained that a problem was that the case detection rate had not risen sufficiently and predicted

10 WHO: Progress Report on the Global Plan to Stop Tuberculosis, 2004 11 A sputum smear positive patient who has been confirmed that he/she has achieved the final goal of treatment and who had once turned sputum smear negative earlier. 11 WHO: http://www.who.int/mdg/goals/goal6/en/index.html 12 Ministry of Foreign Affairs: http://www.mofa.gp.jp/mofa/gaiko/hoken/mdgs/kokensaku.html 13 WHO Report 2006: Global Tuberculosis Control, Surveillance, Planning, Financing 14 WHO: 72% in the African region, 75% in the European region: The low treatment success rate is caused by HIV infection in the former, whereas it stems from drug resistance in the latter. At the same time, it has been pointed out that the result of TB treatment has not been sufficiently monitored (that is, failure in DOTS). (WHO Report 2006: Global Tuberculosis Control, Surveillance, Planning, Financing) 15 WHO Report 2006: Global Tuberculosis, Control, Surveillance, Planning, Financing

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that the goal of reaching 70% could be attained by 2013 if TB control was not intensified in the near future.16

Figure 1 – 3: Progress toward the 70% case detection target

Source: WHO Report 2007: Global TB Control Surveillance, Planning, Financing

1 – 3 – 5: Declaration of health emergency of TB in Africa The WHO declared TB a public health emergency in pertinence to the extensive prevalence of TB in Africa in August 2005 at the Regular Meeting in which ministers of Health participated from 46 African member countries.17 In Africa, the numbers of both TB-infected persons and deaths have been rapidly increasing due to the spread of AIDS. From a global view, TB imposes its burden mostly in Africa. In general, in regions other than Africa, the TB epidemic has been stable or on the decrease and it is believed that the MDGs of halving the prevalence and mortality will be attained by 2015. On the other hand, circumstances in Africa have been deteriorating and the WHO came to the decision to make this declaration based upon the assumption that the goals could not possibly be achieved by the situation in Africa.

16 Final Report of the 2nd Meeting of the DOTS Expansion Working Group. WHO/CDS/TB.2002.303 17 WHO: http://www.who.int/tb/features_emergency_declaration/en/index.html

Case detection rate, smear-positive cases (%) )

It is predicted that the target will be reached by 2013 if progress is made at the average (%) annual increment taken from 1994-2000.

The total number of smear-positive cases notified (DOTS and non-DOTS) of estimated cases (%)

The number of new smear-positive cases notified under DOTS of estimated new cases (%)

DOTS begins

WHO target 70%80

70

60

50

40

30

20

10

0 1990 1995 2000 2005 2010 2015 year

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Throughout the world, there are over nine million new cases and about two million deaths per year. Out of these, Africa carries the burden of 2.4 million new cases and 540 thousand deaths. Despite the fact that Africa shares merely 11% of the world’s population, one out of four TB patients and TB deaths arise in Africa. The WHO called for mobilizing funds to scale up the DOTS strategy and arrest the spread of tuberculosis and HIV.18 1 – 3 – 6: New strategies from 2006 Under recent African circumstances in which the case detection rate still hovers low and the TB burden has been expanding, it is argued that it may be necessary to move farther from the conventional emphasis on smear-positive TB (under DOTS with the chief aim to stop TB by focusing upon the detection and treatment of patients who have contracted the most contagious form of TB). To put it another way, it may be required to take stepped-up measures to deal with the issue of persons who are co-infected with TB and AIDS and expand the use of private medical institutions. The conference of the Stop TB Partnership Working Group held in October 2005 (to be discussed in depth under “1 – 4 – 1: Sop TB Partnership”) issued the “Global Plan to Stop TB for 2006-2015,” which aims to scale up TB/HIV control measures, Public-Private Mix (PPM) measures, and multidrug-resistant TB control measures etc..19 The “Global Plan to Stop TB for 2006-2015” includes the following targets in order to achieve MDG6.

18 (WHO: http://www.who.int/tb/features_emergency_declaration/en/index.html) 19 WHO: The Global Plan to Stop TB 2006-2015, Actions for Life, 2006

MDG6. Target 8: “Halt by 2015 and then begin to reverse the incidence of malaria and other major diseases.”

In order to achieve this:

(By 2005: detect at least 70% of new sputum smear –positive TB cases and cure at least 85%

of these cases)

By 2005: To be sustained or exceeded by 2015: At least 70% of people with infectious TB will be diagnosed and at least 85% of those diagnosed will be cured.

By 2015: The global burden of TB diseases (disease prevalence and deaths) will be reduced by 50% relative to 1990 levels. The number of people dying from TB in 2015 should be less than 1 million.

By 2050: The global incidence of TB disease will be less than one per million population.

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Specifically, the new ten-year plan is intended to “achieve universal access to scaled-up TB control.” The plan is based upon the “Stop TB Strategy.” It contains the contents of Beyond DOTS as well as DOTS, i.e., is more wide ranging, premised upon the fact that the conventional strategy focusing upon smear-positive TB control has produced a steady effect but faces some problems. The “Stop TB Strategy” has the following six components: ① Pursuing high-quality DOTS expansion and enhancement ② Addressing TB/HIV, MDR-TB, and other challenges (Refer to Section 2–2–2:

Multidrug-resistant TB control in Chapter 2.) ③ Contributing to health system strengthening ④ Engaging all care providers ⑤ Empowering people with TB, and communities ⑥ Enabling and promoting research 1 – 4: Major international organizations for TB control The international community addresses TB control in global coordination. The main three organizations are discussed below: 1 – 4 – 1: Stop TB Partnership The Stop TB Partnership is composed of the WHO, IUATLD (refer to 1 – 4 – 2: International Union Against Tuberculosis and Lung Diseases), and national/private aid organizations. It was founded in 1998 under the idea that these members would stand up against the global crisis of TB in coordination among international organizations and aid organizations instead of their separate cooperation activities. The number of member organizations is over 400 as of 2005. (The Ministry of Health, Labor and Welfare is a member of the Board representing the Japanese Government.) The organizational structure of the Partnership is shown in Figure 1 – 4 below. The core consists of the three bodies illustrated in the middle column. The WHO plays an essential role in the Partnership in that it assumes the responsibility of working as its secretariat. Nevertheless, it keeps its independence working under the initiatives of the Global Drug Facility (GDF) and the Coordinating Board and is not an advisory committee of the WHO. Seven Working Groups (WGs) are formed to address the chief issues of today (DOTS Expansion, Multidrug-resistant TB, TB/HIV, New TB Drugs, New TB Diagnostics, New TB Vaccines, and Advocacy, Communication, and Social

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Mobilization). The WGs keep greater independence in their financing and management than the three bodies. That is to say, each WG raises funds and initiates its own projects. Each WG shares each country’s experiences, formulates standardized guidelines, and develops new approaches, thereby steadily scaling up the strategies. JICA renders cooperation to the Stop TB Partnership through attending WG meetings for DOTS Expansion and TB/HIV, etc. together with the project experts dispatched to each country as well as their counterparts. Under the DOTS Expansion WG, there are sub-working groups: Laboratory Strengthening, PPM, Childhood TB, and TB and Poverty. Each WG has been making efforts to draw up guidelines in more detail.

Figure 1 – 4: Structure of the Stop TB Partnership

Source: The Global Plan to Stop TB 2006-2015 (WHO) 1 – 4 – 2: The International Union Against Tuberculosis and Lung Diseases (IUATLD) It was founded in 1920 and was renamed the IUATLD in 1989. It is a world union organization constituted of private institutions (e.g., the Japan Anti-tuberculosis Association from Japan). It is an organization to prevent and stop tuberculosis and lung diseases particularly in low-income countries in the world. It has seven regional offices in the world (in Africa, South Asia, Asia-Pacific, Europe, Central and South America, the Middle East, and North America).

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The World Conference on Lung Health of the IUATLD (or the IUATLD World Conference for short) is held each year. This Conference is somewhat different from a meeting of researchers/scholars. That is, the Conference is characterized by the feature that a number of professionals in tuberculosis and other lung diseases come together not only to present their papers and exchange opinions but also to look into the ways in which various measures are implemented in each country and analyze problems. Since professionals including researchers and public administrators of TB control from many countries attend this IUATLD World Conference, the WG meeting of the Stop TB Partnership is held a few days prior to the Conference. In 2005, a joint meeting of three WGs (DOTS Expansion, TB/HIV, and DOTS-plus) was held before the Conference.

Figure: 1 – 5: Organization Chart of the IUATLD

Source: http://www.iuatld.org/full_text/en/frameset/frameset.phtml 1 – 4 – 3: Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) The Global Fund was created in 2000 as a private organization to give assistance to fight AIDS, tuberculosis, and malaria. Its headquarters are located in Geneva. Each round receives a proposal, to which funds are allocated. It was established separately from the United Nations with the aim of dealing with issues quickly by bypassing the gigantic bureaucratic organizations of the UN. A Country Coordinating Mechanism (CCM) is separately formed for each country as a

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system to process applications for grants and to implement and monitor the project. A committee is established to represent the civil society of the country in question and fulfills similar functions to those of a board of directors. The committee is constituted, for instance, of the ministry of health, international organizations, and non-governmental organizations including aid groups in the country in question. Each round processes an application for a project. However, proposals submitted by sub-recipients (governmental organizations, donors, and NGOs) that implement the project are screened from a technical viewpoint by the Technical Review Panel located in each country. As for accepted proposals, the principal recipient (normally the ministry of health of the country in question, but an international organization, for instance, in North Korea and Myanmar) submits an application to the GFATM. After being approved by the GFATM, the principal recipient and the GFATM conclude a program grant agreement (PGM). The World Bank remits the fund to the principal recipient, who then makes payment to the sub-recipient. For the implementation and management of the project, it is necessary to obtain authorization from the Local Fund Agency (local supervisory organization).20 The duration of a project normally extends for a period of five years, but based upon evaluation of the performance during the initial two years, its continuation is decided for the following three years.

20 The principal recipient (PR) needs to submit an application for the remittance of the fund periodically as well as a progress report and financial report, The Local Fund Agency confirms the relevance of the documents submitted and recommends payment of the world fund according to the progress. When no progress is made under the project, the secretariat requests remedial measures.

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Chapter 2: Approach to tuberculosis

TB control has been implemented under DOTS or a strategic package. The DOTS strategy is a measure based upon the perspective of public health and focuses upon the detection and treatment of patients with smear-positive TB, which is the most infectious form of TB, through public medical institutions. It has been proven that the strategy is cost effective and also yields good treatment success. Hence, as discussed under 1 – 3 – 4: DOTS Expansion and future prediction of TB in Chapter 1, it has been adopted in 182 countries/regions out of 210 countries/regions in the world (as of 2004). In recent years, the “Beyond DOTS” strategy, which is a package to be injected as an additional input at a stage when treatment success and case detection rates have risen to certain levels, has been developed and implemented depending upon the progress and circumstances of each country.

The “Global Plan to Stop TB for 2006-2015” (discussed in 1 – 3 – 6: New strategies from 2006) presents an explanation of “Beyond DOTS” as one package with DOTS. It is believed that this interpretation will be more widely used in the future. On the other hand, it should be noted that DOTS still remains the basis underlying TB control and that this report is a reference material for JICA’s staff. Hence, in this paper, DOTS and Beyond DOTS are separately explained to make the situation clear. The relationship between DOTS and Beyond DOTS is equivalent to that of a tree trunk and its branches. That is, only when the DOTS strategy has been sufficiently strengthened can TB control be scaled up with selective Beyond DOTS measures. 2 – 1: Capacity development for DOTS implementation (Midterm goal 1) 2 – 1 – 1: What is DOTS? DOTS is an acronym to indicate inclusive strategies of primary health services implemented to detect and treat TB patients. A patient who has been detected must be medicated every day for a period of 6~8 months. Even if the conditions of the patient have improved or the patient’s complaints have vanished, he/she needs to keep taking strong drugs that may cause harmful side effects. In order for the patient not to default from the course of treatment, it is recommended that the patient takes drugs under the direct observation of a medical professional for the initial two months as part of the DOTS strategy. Hence, although depending upon the conditions of the disease and also considering the patient’s

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accessibility to the clinic or adherence21, a nurse or a midwife who has received proper training carries out microscopy and medication confirmation at a peripheral medical facility or a health center in a village, whereby every patient is able to receive quality-assured treatment and bacteriology.

Figure 2 – 1: Conceptual diagram of the DOTS implementation system <Minimum unit of TB control> 2 – 1 – 2: Components of DOTS DOTS stands for “Directly Observed Treatment, Short-course.” It originally meant a short-term chemical therapy carried out under direct supervision. The direct observation of therapy (DOT) should be performed for at least the first two months. Going beyond the treatment method, DOTS is now globally used to indicate a strategic package for TB control consisting of five components, upon which the WHO lays emphasis in TB control in developing countries.

21 The term is used to mean “medication observance.” The term “compliance” that has been used so far gives an impression that a patient takes medication under the decision or direction of the medical service provider. On the other hand, “adherence” connotes the patient’s will and attitude that he/she positively participates in the decision on treatment policy and carries out and continues the treatment on his/her own accord.

National TB program

Province/prefecture

< Roles of the province/prefecture> Monitoring, evaluation, supervision, treatment statistics, and logistics such as drugs and testing reagents

<Roles of the county official in charge of TB control>

Monitoring, evaluation, supervision, treatment statistics, and logistics such as drugs and testing reagents

DOT

County official in charge of TB control

Health Center

TB patient

To formulate guidelines and training modules; monitoring, evaluation, supervision, treatment statistics, and logistics management

<Roles of the health center> Detection, treatment, recording, and reporting of patients

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(1) Political commitment with increased and sustained financing

TB control must be carried out nationally and for a long period of time. Hence, it is essential to have a government’s active involvement to assure adequate funding and competent human resources. DOTS is incorporated into the existing health care system and implemented at peripheral levels in local areas under the command of the central government. (2) Case detection through quality-assured bacteriology

First, human and financial resources must be concentrated on the detection and treatment of patients with sputum smear-positive TB that is the source of infection. Sputum smear bacteriology with a microscope is performed at the general primary medical level (the peripheral facility near residents) so that symptomatic patients can have easy access. (3) Standardized treatment, with supervision and patient support

Immediately after the beginning of the treatment, the patient discharges a lot of bacilli (i.e., is highly infectious). Hence, what is critically required is to reduce the risk of infecting other persons around the patient during the first two months’ treatment (called the initial phase). For a period of at least these two months, it is of prime importance to carry out standardized short-course chemotherapy under direct supervision for a patient with sputum smear-positive TB. (4) An effective drug supply and management system

A system should be built to ensure and maintain a stable supply of expendables including quality-assured anti-tuberculosis drugs and diagnostic reagents so as not to interrupt the treatment to TB patients. (5) Monitoring and evaluation system, and impact measurement

DOTS is a strategic package composed of the following five pillars: (1) Political commitment with increased and sustained financing (2) Case detection through quality-assured bacteriology (3) Standardized treatment, with supervision and patient support (4) An effective drug supply and management system (5) Monitoring and evaluation system and impact measurement

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Every detected patient must be registered, and the progress and results of his/her treatment need to be monitored and analyzed based upon the result of sputum smear microscopy. To that end, it is essential to develop a standardized TB registry and reporting system.

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2 – 1 – 3: Case detection and monitoring of treatment under DOTS Patients are detected under DOTS in the procedure shown in the following

Figure 2 – 2. Figure 2 – 2: TB diagnosis (sputum smear-positive pulmonary TB) under DOTS

※ Smear-negative pulmonary tuberculosis means that sputum smear microscopy detects no

Mycobacterium tuberculosis but a person is diagnosed through his/her symptoms and radiography as a TB patient by a physician. The case is classified under a different category from the case of smear-positive pulmonary tuberculosis and is not included in the case detection and treatment success rates to be achieved under the DOTS strategy.

Suspicion of pulmonary TB (person with symptoms) (coughing for 2-3 weeks, sputum, weight loss, chest pain, expectoration of blood, hard breathing, etc.)

Sputum smear microscopy (To color acid-fast bacilli by using the method of

Ziehl-Neelsen for microscopy)

Negative 3 times Positive 1 time

Diagnosis by radiology and a physician

Medication of non-targeted antibiotics

Symptoms do not improve.

Retesting of sputum

Negative 3 times

Diagnosis by radiology and physician

Diagnosed as TB Diagnosed as not TB

To give treatment as sputum smear-positive pulmonary TB

To consider other possibilities To give treatment as sputum

smear-positive pulmonary TB

Positive 2-3 times

Diagnosed as TB

Positive I time or more

Improved symptoms

(non-TB case)

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Sputum smear microscopy is carried out at the following intervals during the treatment to check whether it is bringing about a satisfactory effect, that is, whether it has converted smear positive to smear negative (in case of the six-month short-course regimen). ① At the end of the initial phase (initial intensive phase of treatment) ② Mid-point of the maintenance phase (in the fifth month) ③ Final month (the sixth month) 2 – 1 – 4: Characteristics of DOTS The DOTS strategy is characterized by: ① A good command of patients through the TB registry system

A patient is detected through sputum smear microscopy, accurately recorded, and reported regarding his/her treatment progress, thereby making sure that each patient is provided proper treatment (i.e., to begin and complete the course of treatment and confirm its result). It has been demonstrated that the tracing system, in which each and every patient is picked up and followed through until his/her complete recovery, eventually leads to measures to address the source of TB infection for the entire community (public health activities).

② Detection of symptomatic patients primarily through sputum smear microscopy and its treatment

Priority is given to the detection and treatment of patients with smear-positive pulmonary tuberculosis that poses the most serious problem to public health (in that Mycobacterium tuberculosis is discharged and infects other persons).

③ A package of a series of measures including case detection, supervision of medication, supply of drugs, and sustainable management

The DOTS strategy does not merely mean that TB patients take their drugs in front of a medical professional, that is, direct observation of therapy (DOT). A decisive difference between DOTS and DOT lies in the fact that the WHO has broadened the former’s definition to include a system to provide proper TB treatment (whether quality-assured bacteriology is performed, whether quality-assured drugs are properly distributed, and whether monitoring and evaluation are appropriately carried out).

④ A package covering measures from prevention to treatment The DOTS strategy contains the management of a patient including a series of

actions – prevention, bacteriology/diagnosis, and treatment. Furthermore, another feature is that it is a comprehensive package integrating political commitment as

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well. ⑤ Reasonable treatment cost per patient (US$10~30) with a high cure rate ⑥ Being based upon the numerical targets to be reached to stop TB

The DOTS strategy is grounded upon the model that enables the achievement of a 70% detection rate of patients infected with smear-positive TB, i.e., the most contagious TB, and an 85% treatment success rate, thereby reducing the tuberculosis incidence rate by 5~10% annually, or to put it another way, halving TB within 15 years (under the condition of no complications of HIV).

From the perspective of quality control, it is essential to carry out monitoring,

evaluation, and supervision22 and assure the accuracy of sputum smear microscopy. 2 – 2: Capacity development for Beyond DOTS implementation for the vulnerable

population (Midterm goal 2) A TB case detection rate of 70% has not yet been achieved globally. The countries that have failed to reach the target are taking measures to expand and maintain the quality of DOTS, which lies at the heart of TB control, to raise the treatment success rate. On the other hand, it has become obvious that further actions, or measures, so to speak, beyond DOTS, are required to scale up TB control in addition to the basic DOTS strategy.

For instance, it may be difficult to achieve the WHO’s targets in the rates of case detection and treatment success when there are residents who have difficult access to public medical services in developing countries due to problems in public health administration or geographical/demographic factors. The DOTS strategy has shown some limitations to varying degrees depending upon the extent to which the public health and medical system is developed in the country in question. That is, after the case detection rate has risen above 50%, it is not possible to reach 70% or more only through the expansion of DOTS, which targets public medical facilities under the leadership of public health administration. (The numerical figure of 50% is only an experiential one calculated from past projects implemented by JICA. Thus, it is only an approximate yardstick.) In addition, looming large are a couple of factors that are detrimental to the treatment success rate as well as the case detection rate including the spread of HIV infection and the emergence of drug-resistant strains of Mycobacterium 22 In some cases, the term is used to indicate “supervision by round.” However, in this context, it is used to include the meaning of retraining for rectification or solution of problems found in the program by making use of the result of assessment as well as through onsite supervision.

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tuberculosis. In order to solve these problems, a strategy called “Beyond DOTS” has been proposed, which expands the scope of the DOTS strategy under the concept that is not included in the basic DOTS strategy. The “Beyond DOTS” strategy covers a wider range and contains the measures to be added to the basic DOTS strategy only when the latter has been thoroughly implemented. Hence, it should be applied only after due consideration of the necessity and possible effect according to the circumstances of each country. It will be essential to bear this point in mind whenever it is introduced under JICA’s cooperation project. JICA will be able to render good-quality cooperation to Community DOTS, urban DOTS, PPM, and collaborative TB/HIV (particularly in sub-Saharan Africa where the HIV infection rate is high) in the light of its experiences, possible input resources, and impact. On the other hand, JICA may find some difficulties in extending technical cooperation to DOTS-plus (Refer to 2-2-2 (1)) and childhood tuberculosis.

Figure 2 – 3: Relational illustration between DOTS and Beyond DOTS

Caused by disease Caused by measures

TB patients TB patients

Patients with difficult accessibility to public medical facilities in

urban aress

Patients with difficult accessibility to public medical

facilities in rural areas

Childhood tuberculosis

Multidrug-resistant tuberculosis patients

TB/AIDS co-infected patients

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JICA’s policy is that provides cooperation primarily based upon the DOTS strategy, but some measures of Beyond DOTS will be selectively added. This issue will be discussed in Chapter 3 in greater depth. Figure 2–3 illustrates a figurative tree that indicates the relationship between TB patients and TB control. The leaves metaphorically express TB patients, whereas DOTS is likened to the trunk for delivering necessary treatment services. In this metaphor, Beyond DOTS that addresses the leaves placed in a special environment can be likened to branches. In a country or region where the DOTS strategy, which is the pivot of TB control and illustrated as the tree trunk, has not been yet established, new components indicated as tree leaves should never be introduced. It is also self-explanatory that the measures of Beyond DOTS, that is, large branches, cannot be implemented under circumstances in which the trunk, or DOTS, is still fragile. In some countries, there may be a marked regional disparity although DOTS coverage is high nationwide. Hence, it is crucially important to confirm the main indicators of TB control, assess the DOTS system, and place top priority on providing necessary cooperation to DOTS before any measures from Beyond DOTS are considered. Note that the right-hand side of the illustration indicates cases in which additional measures should be undertaken due to environment or other factors although the disease is a normal TB, and the left-hand shows measures according to the types of the diseases. 2 – 2 – 1: Measures of greater importance under Beyond DOTS (1) Community DOTS

As discussed above, under the DOTS strategy, a medical professional directly observes that a patient takes his/her drugs for at least 2 months subsequent to the start of the treatment (in the initial phase). Patients normally take their drugs at the medical facility. That is, they need to go to the facility every day. In local areas of developing countries, particularly in rural areas, accessibility to medical services is poor. Hence, it is difficult to motivate a TB patient to adhere to his/her treatment, and the financial burden (transportation cost or loss of hourly wage) also makes it more difficult for him/her to receive treatment regularly. As a result, these countries are faced with the problem that there are many patients who fail to finish (i.e., defaulters from) the course of TB treatment until they are fully recovered.

As a solution to these problems, DOTS watchers are trained (such as the development of village health volunteers in the community), thereby enabling the

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patient to receive DOTS services in his/her community. Thus, access to TB control services is improved and the burden on patients is reduced. This principle underlies the Community DOTS strategy.

Under this system, patients in rural areas receive support for medication management through visiting medical services provided by medical professionals from the health center, community health workers, or village health volunteers. The Community DOTS strategy has been introduced in many developing countries. In the background lie two significant factors: village health volunteers are now placed in many countries, and NGOs have more abundant activity funds thanks to the GFATM and other financing support, thereby making it easier to receive funds for the payment of remuneration for health workers and the training of volunteers.

Due precautions should be taken so as not to destroy the existing services given by the health center and to assure sustainability.

(2) Urban DOTS

Problems of urban tuberculosis in developing countries reflect the special features of their urban problems: a high population density caused by an excessive inflow of population (influx of refugees from other countries, influx of domestic refugees, and inflow of the poor from local areas); the establishment and expansion of poor settlements; extremely poor living environment; and a health and medical service system that is unable to catch up with the increasing population. The characteristics of TB in urban districts in developing countries can be summed up as follows: ・A high rate of sputum smear-positive cases ・Outbreaks of TB from the socially weak ・Outbreaks of TB from foreigners and young adults ・Outbreaks of TB from floating populations and poor settlements In cities, the incidence rate of sputum smear-positive TB is high, which is responsible for the spread of infection, and an intensive density of population also greatly raises the risk of infection. In cities, the inflow and outflow of people are frequent as well, thereby making it very difficult to put TB patients under proper control. Urban tuberculosis is typically characterized by the following: an increasing rate of TB incidence caused by the influx of emigrants from a TB-infected country, and growing cases of drug-resistant TB caused by a lowered treatment success rate because people frequently change their abodes and the

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homeless are on the increase. The medical service system in urban districts heavily depends upon national hospitals, private medical institutions, and pharmacies. This means that the approach through health centers does not work effectively in many cases. It is required to intensify the Hospital DOTS strategy, which is explained below. As measures to deal with such problems, it is essential to strengthen public leadership and build partnerships among public and private health and medical service facilities, NGOs, and residents’ organizations. Another important factor lies in the active participation in implementation. More specifically, it is imperative to have coordination among a variety of organizations such as large public hospitals, many private medical institutions including pharmacies, and medical facilities in a special administrative district. For instance, in Kathmandu of Nepal, as part of the urban DOTS system, JICA built a public-private partnership in which the division of roles is demarcated between the health center and private medical institutions. At the same time, JICA has supported system building including a partnership with the medical system under the jurisdiction of the special administrative district. There are a number of defaulters from treatment in urban districts. What is required is a system to follow up TB patients and encourage their return to treatment. Under such circumstances, the present management system needs to be transformed from service provider-centered TB control to patient-centered TB control. Human resources, information, and facilities more heavily gravitate towards urban districts in comparison to local areas. This means that there is greater availability of medicines in cities. An effective way to carry out TB control in urban districts is to make the maximum use of these advantages. Furthermore, it will also be effective to aim at specific people or groups for TB prevention. Specifically, education and explanation on TB are given to people who are highly susceptible to infection (unemployed young people and people working in occupations with high risk) and groups of people living in high-risk districts (poor settlements) or the whole district. Education for these people will eventually reduce the number of defaulters and enhance the early detection of TB patients. <Hospital DOTS>

In urban districts, there are also many cases in which organizations such as national hospitals are responsible for all TB control measures. Under Hospital DOTS, the responsibility of such medical institutions is limited only to the process

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up to case detection. The health center takes over the responsibility of treatment that extends over a long period of time, because it is difficult for large hospitals to make a follow-up of every patient. TB control under such a system is called Hospital DOTS. The main issues are to prevent hospital-associated infection and take collaborative measures with referral medical institutions to ensure the follow-up of each patient.

(3) Public-Private Mix (PPM)

[Also referred to as Public-Private Partnership (PPP)] The Community DOTS strategy addresses TB problems in local areas. On the

other hand, in urban districts, there are also many cases in which proper DOTS services cannot be delivered to patients under the basic DOTS strategy. That is, TB control only through public medical facilities may fail to produce a good effect in cities in particular, because private medical institutions and pharmacies that sell anti-tuberculosis drugs often deliver TB services. The underlying reasons are twofold. First, non-public medical institutions may lack sufficient knowledge, thereby failing to give correct treatment. Second, TB control through public medical facilities is unable to cover every case because a sufficient number of health centers has not been established.

The PPM or PPP approach addresses these issues in order to step up TB control in collaboration with private medical institutions in addition to public medical facilities. In a number of cases, it is carried out in combination with Urban DOTS and multidrug-resistant TB control (DOTS-plus). In the Philippines, for instance, in local areas where people often use private medical institutions or in urban districts where people use private medical institutions with great frequency, there is great need to incorporate private medical institutions into TB control.

Besides PPM, there is an approach in which public medical institutions do not charge for their TB treatment care service and anti-TB drugs in order to increase the competitiveness of public institutions.

(4) TB/HIV (TB/HIV co-infection)

Collaborative TB/HIV control is required from the standpoints of both TB control and HIV control. To put it simply, an increment in the number of HIV-infected persons has induced an upsurge in the number of TB patients and at the same time, in the number of deaths. TB is basically a curable disease with

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affordable treatment. The same can be said of tuberculosis among HIV carriers as long as it is detected at an early stage. HIV control also will benefit greatly from building a system under which TB patients who have completed TB treatment will be able to receive proper medical treatment for AIDS.

In fact, there are a number of deaths in the middle of treatment because a patient comes to a health center at a later stage and because HIV infection accelerates the progress of TB conditions. The biggest challenge, from the viewpoint of the HIV service provider, is that TB is the most opportunistic infection and brings about a number of deaths despite the fact that it is a curable disease.

1) The world situation

Approximately one third (13 million persons) out of the total number of HIV-infected persons (about 40 million persons) are also infected with TB.23 In sub-Saharan Africa, TB was on the decrease until the mid-1980s. However, in 2005, the number of TB patients approximately quadrupled.24 Increases in population and improvements in TB case detection also contribute to this increment, but it is believed that HIV infection is a major factor. For example, in Zambia, the national rate of HIV infection is 17%25, whereas 76% of TB patients are diagnosed as HIV positive at the JICA project site.26 It is reported that in urban districts, about 83.2% of TB patients are infected with HIV.27 The registered number of TB patients was approximately 100 per 100,000 persons in the 1980s. The number continued to rise and exceeded 500 in 2002.28 According to the HIV infection surveys carried out in 2002 and 2004 in Cambodia where the HIV infection rate was only 1%, the percentage of TB patients infected with HIV was 10% and 8%, respectively (JICA Cambodia TB Control Project Report, 2003). These findings in Zambia and Cambodia imply that a factor contributing to the increased number of TB patients is HIV infection. The situation plotted on the world map indicates that countries with high TB incidence rates and countries with high HIV infection rates nearly overlap. In particular, it is important to note that tuberculosis is a serious problem when HIV/AIDS control measures are considered for sub-Saharan Africa.

Figure 2 – 4: Estimated TB/AIDS co-infection rate – WHO (2005) 23 WHO TB Department, fact sheet on tuberculosis 24 http://www.who.int/hiv/toics/tb/tuberculosios/en/ 25 2006 Report on the global AIDFS epidemic: UNAIDS 26 Mizutani, Tetsuo, et al.: HIV/AIDS in Sub-Saharan Africa, with focus on the Republic of Zambia, VIRUS REPORT, Vol. 3, No. 1, 2006 27 Epidemiological Fact Sheet: WHO/UNAIDS, August 2006 28 WHO TB Epidemiological Profile as of May 31, 2005

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Kaposi’s sarcoma

Pneumocystis carinil pneumonia Candidiasis (esophagus, etc.)

Cryptococcus meningitis Cerebral toxoplasmosis

Cytomegalovirus retinitis/pneumonia Atypical mycobacteriosis

Malignant lymphoma Late stage – HIV

disease (AIDS)

Asymptomatic stage Primary infection stage (acute infection)

window period

Virus

Infection with HIV Herpes zoster

Possible to have symptoms when CD4 counting is less than

200

Progress of HIV infection

CD4-Positive lymphocyte counting

Tuberculosis

HIV-associated dementia

Source: WHO Report 2007: Global TB Control Surveillance, Planning, Financing

Figure 2 – 5: Progress of HIV infection

Note: CD4, or cluster of differentiation 4, count: CD4 is one type of lymphocyte that fulfills the central role of immune function. It is used to confirm the conditions of an HIV carrier’s immunity. After infection, the count goes down gradually. When it goes below 200, the carrier can be attacked by opportunistic infections. TB is one of the most contagious diseases and can infect even healthy persons.

Areas where TB infection spreads with the prevalence of HIV

HIV prevalence in TB cases, 15-49 years (%)

0-4 5-19 20-49 50or more No estimate

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Hence, a person who has a CD4 count of 500 can contract TB. This means that an HIV-infected person is most susceptible to TB infection and disease, whereby TB is the leading cause of death among HIV-infected persons. Source: Anti-HIV therapy and medication support (AIDS Clinical Center, International Medical Center of Japan)

2) TB/HIV control

It is believed that collaboration between TB control and AIDS control will yield positive effects for both control measures. Under the Stop TB Initiative, activities are carried out with the main focus upon the following issues:29

In response to the full-scale introduction of anti-retroviral therapy, the Joint

United National Programme on HIV/AIDS (UNAIDS) and the WHO announced their view in June 2004 that HIV antibody testing for TB patients would form a part of standard treatment. At the same time, the UNAIDS/WHO Joint Policy

29 Interim Policy on Collaborative TB/HIV Activities, WHO/HTN/TB/2004.330

Establish the mechanism for collaboration (1) Set up a coordinating body (2) Conduct surveillance of HIV prevalence among TB patients (3) Carry out joint TB/HIV planning (4) Conduct monitoring and evaluation 1. Decrease the burden of tuberculosis in people living with HIV/AID (1) Establish intensified tuberculosis-finding (2) Introduce isoniazid preventive therapy (3) Ensure tuberculosis infection control in health care and congregate settings 2. Decrease the burden of HIV in tuberculosis patients (1) Provide HIV testing and counseling (2) Introduce HIV prevention method (3) Introduce cotrimoxazole preventive therapy (4) Ensure HIV/AIDS care and support (5) Introduce anti-retroviral therapy (ART)

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Statement30, the Guidelines for HIV Surveillance31, A guide to Monitoring32, and the Clinical Manual33 were published or revised. In the call for proposals by the GFATM in March 2005, it was decided that one of the requirements for funding was to incorporate the TB component into AIDS control and the AIDS component into TB control.34 Thus, it is an inevitable trend to integrate the TB/HIV components in cooperation either for AIDS control or for TB control. The above components of TB/AIDS control are based upon the experiences gathered from the pilot projects implemented in six countries including Malawi, South Africa, and Zambia. Currently, TB/HIV control has been implemented in Ethiopia, Kenya, Malawi, Mozambique, Nigeria, South Arica, Uganda, Tanzania, Zambia Zimbabwe, Republic of Cote d’Ivoire, the Democratic Republic of the Congo, Rwanda, and Senegal. One challenge faced by TB/HIV control is that collaboration has not progressed as expected. TB is an opportunistic infection that infects other persons, thereby posing a menace to HIV-infected persons. As discussed above, the TB incidence rate is extremely high among HIV carriers. That is, even though the HIV infection rate is 1% nationwide, the number of TB patients may double per year. Thus, tuberculosis cannot be dealt with merely as an opportunistic disease among HIV-positive persons. It is reported that AIDS control administration often lacks this awareness, which poses a serious problem. On top of this, TB control has a long history. As a result, it has established an approach that is refined to a high level. At the same time, it is not a project that attracts a lot of attention. On the other hand, HIV/AIDS control is a new project in which a massive amount of funds are injected, many actors are involved, and multisectoral activities are mainstreamed. Thus, there are differences in the persons involved, history, and approach to activities. Such dissimilarities are reflected in the present situation.

2 – 2 – 2: Others (1) Multidrug-resistant tuberculosis control (DOTS-plus)35

A form of tuberculosis caused by strains of Mycobacterium tuberculosis against which multiple drugs do not work is called multidrug-resistant tuberculosis (MDR-TB, 30 (UNAIDS/WHO Policy statement on HIV testing, June 2004) 31 Guidelines for HIV surveillance among tuberculosis patients (second edition): WHO/HTM/TB/2004.339 32 A guide to monitoring and evaluation for collaborative TB/HIV activities: WHO/HTM/TB/2004.342 33 TB/HIV Clinical Manual: WHO/HTM/TB/2004.329 34 The Global Fund to Fight AIDS, Tuberculosis and Malaria: Guidelines for proposals: Fifth call for proposals. Geneva, March 17, 2005 35 XDR-TB: In the past, multidrug resistance was defined as a bacterium that shows resistance to two types of anti-tuberculosis drugs. Today’s new findings reveal that there is a form of tuberculosis that has resistance to three types of drugs in the second line (including six types in total) called XDR-TB. This tuberculosis begins to pose a problem in that there is no treatment that meets the global standards.

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or Mycobacterium tuberculosis, that shows resistance to at least rifampicin and isoniazid). Multidrug-resistant tuberculosis has the following causes: 1) Interruption of the patient’s treatment 2) Wrong prescription by physicians 3) Inferior-quality drugs The TB control strategy including measures to control multidrug-resistant tuberculosis is called DOTS-plus. The DOTS-plus strategy includes standardized procedures in addition to the contents of the DOTS strategy; drug sensitivity testing to confirm multidrug-resistant tuberculosis; procurement of special drugs; standard precautions to prevent hospital-associated infection to other patients; and surgical operation. Mycobacterium tuberculosis sometimes undergoes gene mutation into a strain of drug-resistant bacterium although such mutations do not occur as frequently as they do in the influenza virus.36 Under the DOTS strategy, medication is so designed as to be able to cure tuberculosis. That is, four types of anti-tuberculosis drugs are administered in combination so that TB can be cured even if the bacterium undergoes gene mutation into a strain resistant to one type of drug. In the case of multidrug-resistant tuberculosis, the anti-tuberculosis drugs that are normally used (first-choice drugs or first-line drugs) do not work. Therefore, second-line anti-tuberculosis drugs are used. If these drugs have no efficacy, the form of tuberculosis against which no drugs work may spread extensively. Therefore, it is vital to supervise medication under direct observation more strictly than when treating normal types of tuberculosis so that no patients default from treatment. Surgical removal is opted for in some cases. In Japan, it is recommended to have treatment at hospital. In this case, it is critically necessary to strengthen the measures to prevent hospital-associated infection so that medical staff and other patients do not become infected. Treatment for this multidrug-resistant tuberculosis involves a few difficulties: first-line drugs cost US$10~30 per person, whereas the cost of second-line drugs jumps to about US$3,000; the duration of treatment extends over a period of 18 months or more (the normal duration being 6~8 months); and the treatment success rate drops to less than half .37

36 In general, there is one inherently (naturally) resistant bacterium per one million bacilli of Mycobacterium tuberculosis to one drug. It is calculated that there is about one inherently resistant bacterium per one trillion bacteria (one million x one million) that is resistant to two drugs when two drugs are taken. It is believed that there are about from 10 million to one billion bacilli per lesion in the lung. Thus, it is possible to avoid an increase in the number of resistant bacteria by taking at least two drugs. 37 “Drug- and multidrug-resistant tuberculosis (MDR-TB) – Frequently asked questions”

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There is a global framework to address multidrug-resistant tuberculosis that often involves difficult issues in its control. It is the Green Light Committee within the Stop TB Partnership. It has been founded because technical and financial difficulties surround multidrug-resistant tuberculosis and failure to control it may result in the spread of a form of tuberculosis for which no treatment technology has yet been developed. Once the Committee approves the proposal submitted by a nation infected with multidrug-resistant tuberculosis, the country is able to receive technical and financial support (including the supply of second-line anti-tuberculosis drugs). JICA will recommend that such countries receive support from the Green Light Committee. Likewise, JICA extends cooperation emphasizing the prevention of multidrug-resistant TB, contributing toward raising case detection rate while maintaining a high treatment success rate. (2) Childhood tuberculosis

Necessary measures should be taken against childhood tuberculosis in countries where tuberculosis is prevalent. It is difficult to take sputum from small children, thus the detection of tuberculosis among babies with sputum microscopy, which is one of the DOTS’s basic strategies. Hence, a special program (diagnosis with radiography, etc.) needs to be offered to small children. There is a high probability that childhood TB cases are excluded from the statistics because they cannot be easily detected by sputum microscopy. A first glance may give the impression that the burden of childhood tuberculosis is relatively small. It is essential to be aware of this fact when measures are considered.

One possible measure may be contact examination. When a sputum smear-positive patient is detected, the contact examination should be given,to his/her family members, thereby efficiently finding a patient with childhood tuberculosis. Persons near the patient are at the highest risk of being infected and a number of infection cases take place within the family, i.e., of those who keep in close contact with the patient. Thus, contact examination is effective for finding cases. The contact examination given to persons near sputum smear-positive patients carries great significance for high-TB-prevalence countries or regions. Indeed, in some countries, contact examinations are given to small children aged five or less.

In advanced countries including Japan, the contact examination is conducted to detect a TB-infected person at an early stage, that is, before the onset of tuberculosis to stop its development into a full-blown disease with preventive medications. However,

http://www.who.int/tb/dots/dotsplus/faq/en/index.html

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the examination is hardly carried out in developing countries. The infection source of childhood tuberculosis is, in many cases, a family member who has not completed his/her treatment, and there is a relatively high possibility that a child is infected with drug-resistant tuberculosis. Hence, it is essential to keep this point in mind. 2 – 3: To summarize JICA’s past cooperation JICA has extended its aid for TB control in many countries by integrating various schemes such as project-type technical cooperation, training program, and grant aid in close partnership with international organizations and related aid organizations. Since 1995, JICA has been implementing its cooperation projects primarily in accordance with the DOTS strategy that is the global standard. Among countries where JICA has rendered cooperation, program-type technical cooperation markedly stands out in countries where JICA has implemented project-type technical cooperation. To put it specifically, by using various schemes, JICA has provided assistance for capacity development, thereby enhancing human resource development, system building, and institution building. Basically, the project aims to improve the national tuberculosis program (NTP) so that the government of the recipient country will develop the capacity to carry out the DOTS strategy on its own. <Features of JICA’s past cooperation> 1. Aid to introduce DOTS and improve its quality (since 1995) 2. Capacity development focusing upon human resource development for TB control

program nationwide, thereby strengthening the management capacity of the national tuberculosis control program

3. Introduction of the DOTS strategy, which is the global standard, in a form applicable for each country

4. Program-type approach by integrating various schemes 5. Human resource development in as many countries as possible through the training

program in Japan

It has been proven that the DOTS strategy steadily brings about success in the patient’s treatment in many countries. Against this backdrop lies a reason that the DOTS strategy has not grown in answer to the question: “What comprehensive services

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should be provided?” Instead, it has come in answer to the question: “What could be done in developing countries where human resources and systems are limited?” Whenever JICA formulates a project, JICA has modified the DOTS strategy discretionally into a form applicable to the country in question. Specifically, JICA implements a model/pilot project and builds a DOTS model suited to the country in question. Then, JICA implements the model project nationally through the training of health workers who are in direct contact with residents. (1) Development of DOTS suited to the health and medical system of each country

1) To review and evaluate preexisting TB control measures a) To formulate drafts of guidelines and training modules ① Management of patients (detection, medication, and record keeping/reporting ) ② Sputum smear microscopy ③ Logistics concerning anti-tuberculosis drugs and testing reagents etc. ④ Monitoring, evaluation, and supervision concerning ①~③ at the model site b) To revise and formalize the guidelines and training modules (drafts)

(2) To give training to the health staff who keep direct contact with residents to introduce DOTS

(3) Training on monitoring, evaluation, and supervision to administrative officials in charge of tuberculosis control in the provincial, prefectural, and national governments

JICA’s training course in Japan has a history of over 40 years and has

developed human resources who play the pivotal role in TB control and also assume responsibility in the laboratory in each country. The number of persons trained on this training course has reached approximately 1,500. In addition, JICA has rendered cooperation that organically links those participants with JICA’s projects.

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Figure 2 – 6: JICA’s cooperation for TB control by project-type technical cooperation (As of January 2005)

2 – 3 – 1: Technical cooperation JICA rendered cooperation to the Solomon Islands, Yemen, and Nepal, which produced a good outcome. Currently, JICA is implementing projects in the Philippines, Cambodia, Myanmar, Afghanistan, Pakistan, and Zambia. It plans to begin a project in Indonesia in the near future. (Please refer to Appendix 1 – Major examples of cooperation.) 2 – 3 – 2: Cooperation through training, etc. The training course in the area of tuberculosis held in Japan was started in 1963 as “Tuberculosis Control.” It was a four-month course held in partnership with the Japan Anti-tuberculosis Association for medical personnel, primarily physicians, who were involved in TB control. In total, 552 persons participated in the course from 58 countries during the period until 1992.

One outstanding feature of this training course is that it has contributed to the development of human resources in a number of countries for a long period of time. There is the case in which a project is implemented in a given country in combination

Public Health Project in the Solomon Islands

TB Control Improvement

Project (Phase 3) in the Philippines

TB Control Project in Afghanistan

AIDS/TB Control Project in Zambia

Project for Infectious Diseases Control in Myanmar

TB Control Project in the Kingdom of Cambodia

(Phase 2)

TB Control Project in Indonesia

TB Control Project in Pakistan

Community Tuberculosis and

Lung Health Project (Phase 3) in Nepal

TB Control Project (Phase 3) in Yemen

Project-type technical cooperation as of April 2007

Project under way

Project under preparation

Completed project

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with an in-country training course. A fruit of JICA’s project-type technical cooperation is that it is now possible to hold a training course in the laboratory sector in the Philippines. Hence, since fiscal 2006, the training of trainers (TOT) course has been held in the said country. Furthermore, JICA has been conducting training by making effective use of the local resources of developing countries of late. For instance, JICA supports the training of counterparts of a project for Cambodia at a heart hospital in Thailand (built with grant aid and project-type technical cooperation). Thus, JICA now makes active use of third-country resources. When the cooperation policy is reviewed in the future, it will be essential to clearly delineate the distinct roles of human resource development, system building, and institution-building that are carried out under the overall goal of capacity development (3 – 3 – 2: Development and strengthening of input resources in Chapter 3). 2 – 3 – 3: Application of a modified DOTS strategy for each country In the past, guidelines for public health were often formulated from the perspective of what should be done in developing countries. One of the reasons that DOTS has been successfully adopted and produced a good outcome throughout the world is its simplification so that it can be operated in developing countries with limited resources. Specifically, for instance, it can be seen in a simplified laboratory register form (global standard) and patients’ register form, and monitoring and supervision based on the both forms. Nevertheless, the capacity level of the staff, the number and quality of medical facilities, and the conditions of diseases excluding tuberculosis vary in each country. Hence, there is no universally applicable operational approach to the DOTS strategy. The key to success in TB control is to discover the optimum form of feasible DOTS and create DOTS guidelines to meet the conditions of each country. The projects implemented by JICA in the past are characterized by the feature that JICA has followed a process consisting of a series of formulating guidelines verifying the feasibility at a model site and feedback to the TB policy, which is the process of operational researches.,. 2 – 3 – 4: Grant aid Grant aid to the area of tuberculosis has been effectively used in combination with project-type technical cooperation. The aid can be roughly divided into two types: the facility type in which a tuberculosis center or a central tuberculosis laboratory

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is constructed, and the equipment/reagent type in which national tuberculosis control is intensified by supplying anti-tuberculosis drugs and microscopes. The tuberculosis center contributes to functional strengthening of control measures including co-infection and multidrug-resistant tuberculosis as the central control center. Similarly, the tuberculosis laboratory fulfills the role of the national reference laboratory with its strengthened functions of training and external quality assurance. 2 – 3 – 5: Collaboration with volunteer projects Aid to the area of tuberculosis under volunteer program has primarily consisted of the dispatch of health nurses to ensure the enforcement of DOTS at hospitals and health centers. Specific cases are summarized in Appendix 1 “Table A1 – 3: Dispatch of JOCV members to strengthen TB control.” There are many cases of cooperation by volunteers to improve public health systems, as can typically be seen in the dispatch of members for the eradication of smallpox and polio and the strategic dispatch of members, for instance, for anti-AIDS actions. In the future, there is a possibility that JICA will strategically dispatch volunteers in the area of medicine including public health nurses, clinical laboratory technicians, and radiologists, strengthening the national TB program. At the same time, JICA can look toward the possibility of dispatching people from the liberal arts, not from the area of medicine, who wish to participate in volunteer program as has been done in the area of HIV/AIDS. 2 – 4: Human security and tuberculosis38 Tuberculosis and human security are closely related in the following two aspects: first, tuberculosis poses a direct threat to each individual in terms of health and survival that are basic human needs; second, the burden of tuberculosis is concentrated on the poor and vulnerable, thereby further deteriorating their frailty. These two aspects interfere with “freedom from fear” and “freedom from want” that are integral to human security. Not limited to tuberculosis, disease control measures and health/medical improvements eventually contribute to human security. Tuberculosis is a disease that can be detected with a relatively simple method and cured with affordable drugs. In addition, its complete treatment reduces the risk of infecting other persons surrounding

38 Japan International Cooperation Agency: The Republic of Ghana. Final evaluation report of the Infectious Diseases Control Project for the Noguchi Memorial Institute for Medical Research: September 2003

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the patient, and the DOTS strategy, which evidently yields a good outcome, has been established. Thus, assistance for TB control under the DOTS strategy is a significant effort from the perspective of human security. The following sections discuss TB control viewed from human security. (1) DOTS and human security

The DOTS strategy makes it possible to detect TB-infected persons, ensure that they are treated, and lower the risk of infecting others through the complete cure of patients, whereby it enables the prevention of infection of an entire community. In Japan, discrimination and prejudice against TB patients and tuberculosis have been removed due to the progress of TB treatment.39 In this sense, it may be stated that the DOTS strategy is an approach that translates the idea of human security into action. Further, it raises the entire level of the basic health and medical system that provides services to local residents. Hence, the approach may be applied to control measures for other diseases. As one example, the DOTS strategy may be applicable to AIDS treatment (anti-retroviral treatment - ART) that requires medication over a longer period of time than tuberculosis. The cycle of DOTS is relevant to the three phases of risk management: “prevention,” “action,” and “promotion.”40 That is, each phase is respectively addressed by strategies under DOTS: “halting the spread of TB through treatment,” “treatment,” and “development of a health system.”

(2) TB control for the poor

Tuberculosis is tightly associated with poverty as clearly indicated by the fact that it is referred to as a “disease of poverty” (Figure 2 – 7). Over 95% of TB-infected persons and TB deaths are concentrated in the developing world, and mostly the poor fall victim. People in poverty are often faced with a wide range of problems including nutritional conditions, density of housing (poor settlements and illegal settlements in urban districts, etc.), and work environment, thereby multiplying the risk of TB infection and worsening TB conditions.

In fact, it has been reported that the risk factor is 2.5 times higher among the poor than the non-poor and also that the TB prevalence rate is 1.6 times higher among the poor in urban districts than the non-poor in the Philippines (WHO

39 Shimao, Tadao: “Thoughts about future AIDS control measures learned from TB control”: Journal of AIDS Research 3: 45-49, 2001 40 Institute for International Cooperation, JICA: “Poverty reduction and human security – Discussion paper”: November 2005

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Regional Office for the Western Pacific).41 It is reported on China that 78% of TB patients belong to social strata that earn lower than the average income. Tuberculosis is concentrated among the poor. Hence, strengthening of TB control leads to poverty alleviation. The DOTS strategy basically places priority on delivering TB services through public health/medical institutions. However, there are some cases in which the poor are unable to receive such services. If that is the case, it will be necessary to adopt additional measures besides DOTS. Specific examples include free treatment, free food supply to TB patients under the Food-for-Cure by the World Food Programme, urban tuberculosis control, PPM (PPP), and community DOTS.

Figure 2 – 7: Poverty and TB infection risk

(3) Refugees and tuberculosis Refugees from war or civil war are confronted with diverse problems including

housing, food, and health problems. Tuberculosis is one of them. There are too

41 “Reaching the poor: challenges for the TB programmes in the Western Pacific Region”: WHO Regional Office for the Western Pacific, 2004. 33 pages, ISBN929061093X

Lowered nutritional condition Poor and dense work environment

Worseneddisease conditions

Increase in TB infection risk

Increase in the number of TB-infected persons

Worsened poverty/deathInfection to family members Deepened poverty

Poverty

TB infection

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many problems surrounding refugees. Hence, the problem of tuberculosis has been neglected. In fact, 25% of adults die of tuberculosis in refugee camps in Somalia. The death of an adult inflicts an adverse effect on his/her family, especially the children, thereby aggravating problems. The poor environment of refugee camps, much worse than that of poor settlements, magnifies the damage caused by tuberculosis. The fact that a TB patient must undergo the 6~8-month course regimen also creates difficulties. Thus, the TB problem indeed looms large in refugee camps.42

2 – 5: Gender and tuberculosis Tuberculosis poses a menace to women. That is, more women die of tuberculosis than of delivery each year (World Bank 1993). On the other hand, TB infection rates are higher in men than in women. However, the risk of being infected with TB and developing the full-blown disease is 2.3 times higher among women in their 20s~40s than their male counterparts. Similarly, the conditions of the disease are worse among women at the time of diagnosis.43

These problems stem from an inferior environment surrounding women in developing countries, family care being in women’s hands in many cases and difficulty of accessibility to external services including medicines. A glance at the ratio of men to women in some countries reveals that the proportion of women under treatment is lower than the percentage of projected TB-infected women compared with that of men. This evidently demonstrates an unequal situation of women. In recent years, various committees have been established to look into the relationships between gender and tuberculosis. JICA needs to collect information continuously on this issue and reflect the result accurately in its technical cooperation.45

42 “A human rights approach to TB. Stop TB Guidelines for Social Mobilization” WHO/CDS/STB/2001.9 43 “A human rights approach to TB. Stop TB Guidelines for Social Mobilization” WHO/CDS/STB/2001.9 45 Tuberculosis and gender (http://www.who.int/tb/dots/gender/page_l/en.index.html)

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Chapter 3: JICA’s cooperation policy on TB control This chapter discusses JICA’s cooperation policy and approach, and then looks into challenges in TB control. 3 – 1: JICA’s cooperation policy on TB control JICA gives priority to the countries in which tuberculosis brings about a heavy burden and TB control lags behind. It is JICA’s policy to extend its assistance to those priority countries with an emphasis on improving the quality of DOTS and expanding the operation of Beyond DOTS. JICA carries out a careful analysis of the country in question in terms of the implementation system in place, the country-specific cooperation plan and the significance of infectious disease control in the cooperation program for the health sector. In light of all these factors, JICA formulates a cooperation program. A general cooperation policy is that JICA extends assistance to the countries that meet the condition of 1. in the following list, stressing the cooperation of either 2. or 3., or in a combination of components from 2. and 3. For other countries that do not fall in the category 1., JICAs cooperation will not solely focus on TB control, but TB control could be included in a project for other infectious diseases (e.g. HIV/AIDS), or a project for strengthening rural health care. JICA will extend assistance towards capacity development in general for persons involved in TB control such as acceptance of participants in the group course held in Japan. 3 – 1 – 1: Give priority to High-Burden countries Countries where the burden of tuberculosis is serious and TB control lags behind are selected as the priority countries of JICA’s cooperation. The TB burden in a given country is measured by two aspects: first, a country where there are many TB patients (high-burden country) and, second, a country where the TB incidence rate is

<JICA’s cooperation policy on TB control> 1. Give priority to High-Burden countries, high-TB-incidence countries, and

countries where TB control lags behind 2. Place an emphasis on strengthening the quality of DOTS 3. Improve the capacity to implement Beyond DOTS for the vulnerable population

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high. Table 3 – 1 lists countries with a high number of TB patients44 and countries with high TB incidence rates45 in a descending order, respectively. These indicators show merely the static condition, but it is necessary to grasp the dynamic condition of how measures are taken to intensify TB control by analyzing changes in the past several years.

Table 3 – 1: High-burden countries and high prevalence rates

Name of country Order of

High-burden country

Number of TB patients

Order of prevalence

rate

Prevalence rate(per 100,000)

1 India 1 1,851,661 62 1682 China 2 1,319,328 80 1003 Indonesia 3 532,871 40 2394 Nigeria 4 371,642 32 2835 Bangladesh 5 321,996 45 2276 Pakistan 6 286,291 53 1817 South Africa 7 284,538 8 6008 Ethiopia 8 266.288 22 3449 Philippines 9 241,879 31 291

10 Kenya 10 219,582 6 64111 Democratic Republic of Congo 11 204.977 21 35612 Tanzania 14 131.078 23 34213 Uganda 16 106,285 18 36914 Mozambique 18 88,533 13 44715 Myanmar 19 88,345 60 17116 Zimbabwe 20 78,187 7 60117 Cambodia 21 71,130 11 50618 Afghanistan 22 50,249 61 16819 Swaziland 13,029 1 1,26220 Djibouti 6,045 2 76221 Namibia 14,164 5 69722 Lesotho 12,489 4 69623 Botswana 11,551 5 65424 Zambia 70,026 9 60025 East Timor 5,261 10 55626 Sierra Leone 26,266 12 47527 Malawi 52,751 14 40928 Ivory Coast 69,417 15 38229 Togo 22,910 17 37330 Congo 14,659 19 36731 Rwanda 32,627 20 361

44 “Countries with high number of TB patients ”: Estimated number of patients per year (incidence) 45 “Countries with high proportion of TB patients ”: Total TB incidence rate

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32 Burundi 25,188 24 33433 Central Africa 12,670 25 31434 Haiti 26,051 27 305

Infectious Disease Control Team, Human Development Department, JICA (June 11, 2007)

Reference: WHO Report 2007: Global TB Control Surveillance, Planning, Financing

1. Priority countries of cooperation for TB control (1) High-burden countries (with many TB patients): 22 high-burden countries (2) High TB incidence rate (a high proportion of TB patients)

・Countries with high HIV incidence rates ・Post-conflict countries

(3) Countries in which the DOTS strategy lags behind ・Countries in which the case detection rate and the treatment success rate have not

improved for the past 2~3 years (1) High-burden countries (22 high-burden countries: in terms of the estimated number

of TB cases) As explained in Chapter 1, over 80% of 9 million TB patients in the world are

concentrated in the 22 high-burden countries. JICA will extend cooperation to these countries with the highest priority.

In the past several years (as of 2005), an increasing number of new TB patients were detected in parallel with the expansion of HIV infection. Hence, there are some changes in the ranking around the 22nd high-burden country. As of 2005, WHO was looking into the possibility of increasing the number of high-burden countries from 22 to 30. In fact, the WHO annual report of 2005 left out a map of high-burden countries (HBCs).

As for countries other than the 22 countries, JICA is ready to review the priority countries, if required, depending upon the number of patients or incidence rate proportionate to those of the present priority countries, as will be discussed in the following section.

(2) Countries with high TB incidence rates [Table 3 – 2 (right-hand side)]

The fact that a country has a high TB incidence rate means that there is a high risk of a further increase in the number of TB patients in the country. It means, therefore, priority should be given to TB control.

Among countries with high TB incidence, there are two types as can be obviously seen from Tables 3 – 1 and 3 – 2: ① countries with many HIV-infected

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persons and ② countries after the end of civil war. The cooperation extended to each type of such countries is different in terms of its approach and content. An explanation is given in more detail in “3 – 3 – 1.” ※About trends in the TB case detection rate and treatment success rate

Viet Nam and Thailand are still counted as high-burden countries (HBCs), but cited as successful cases just as is Peru, which is no longer listed as an HBC. This is primarily because of marked progress in TB control measures undertaken by the the respectiev government. These two countries are, therefore, excluded from Figure 3 – 1. The exclusion is based upon the assumption that the governments of these countries succeed in strengthening TB control and that there is no longer high necessity for JICA to support the DOTS strategy, which is at the core of TB control, and the Beyond DOTS strategy. The progress of TB control can be measured from the trends in the number of TB patients and TB incidence rates as shown in Figure 3 – 3.

(3) Countries where the DOTS strategy lags behind

The progress of TB control is assessed from the rate of patients who are detected under DOTS (DOTS case detection rate) and the rate of patients who have completed treatment out of those detected patients (treatment success rate). The extent to which the DOTS strategy has been intensified can be measured by changes in the case detection rates under DOTS and the treatment success rates in the past 2~3 years.

Please refer to Figure 3 – 4 as for the performance of JICA’s cooperation in the aid priority countries of TB control.

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Table 3 – 2: Comparison of ranking by the estimated number of TB patients and estimated TB incidence rates

(2005)

Ranking of the estimated number of TB patients*

Persons Ratio (100,000)

HIV infection

rate among HIV

carriers 1 India 1,851,661 168 5.2 2 China 1,319,326 100 0.5 3 Indonesia 532,871 239 0.8 4 Nigeria 371,642 283 19 5 Bangladesh 321,996 227 0.1 6 Pakistan 286,291 181 0.6 7 South Africa 284,538 600 58 8 Ethiopia 266,288 344 11 9 Philippines 241,879 291 0.1 10 Kenya 219,582 641 28

11 Democratic Republic of Congo

204,977 356 17

12 Russian Federation

170,422 119 6.2

13 Vietnam 147,566 175 3 14 Tanzania 131,078 342 29 15 Brazil 111,050 60 14 16 Uganda 106,285 369 30 17 Thailand 91,374 142 7.6 18 Mozambique 88,533 447 50 19 Myanmar 86,345 171 7,1 20 Zimbabwe 78,187 601 60 21 Cambodia 71,130 506 6 22 Afghanistan 50,249 168 ≦0.05

*22 high-burden countries stipulated in 1998

Ranking of estimated incidence rates

Persons Ratio (100,000)

HIV infection

Rate among HIV

carriers 1 Swaziland 13,029 1,262 75.0 2 Djibouti 6,045 762 16.1 3 Namibia 14,164 697 56.2 4 Lesotho 12,489 696 64.5 5 Botswana 11,551 654 69.9 6 Kenya 219,582 641 528.0 7 Zimbabwe 78,187 601 60.2 8 South Africa 284,538 600 58.1 9 Zambia 70,026 600 55.1 10 East Timor 5,261 556 11 Cambodia 71,130 506 6.0 12 Sierra Leone 26,266 475 8.7 13 Mozambique 88,533 447 50.4 14 Malawi 52,751 409 49.6 15 Ivory Coast 69,417 382 24.1 16 Republic of

Kiribati 378 380

17 Togo 22,910 373 16.7 18 Uganda 106,285 369 30.0 19 Congo 14,659 367 25.0 20 Rwanda 32,627 361 16.0 21 D R Congo 204,977 356 16.7 22 Ethiopia 266288 344 10.6 23 Tanzania 131,078 342 29.3 24 Burundi 25,188 334 16.8 25 Central Africa 12,670 314 41.9 26 Gabon 4,256 308 33.9 27 Haiti 26,051 305 11.6 28 Tuvalu 32 305 29 Liberia 9,894 301 17.3 30 Mauritania 9,146 298 4.0 31 Philippines 241,879 291 0.1 32 Nigeria 371,642 283 19.4 33 Eritrea 12,409 282 12.7 34 Mali 37,558 278 9.6 35 Chad 26,482 272 17.9 36 Angola 42,849 269 0.2 37 Senegal 29,699 255 5.2 38 Papua New

Guinea 14,689 250 9.7

39 Gambia 3,677 242 13.1 40 Indonesia 532,871 239 0.8 41 Guinea 22,175 236 8.5 42 Madagascar 43,515 234 3.0 43 Equatorial Guinea 1,172 233 16.6 44 Sudan 82,964 228 8.8 45 Bangladesh 321,996 227 0.1 46 Somalia 18,442 224 5.0 47 Burkina Faso 29,538 223 11.0 48 Bolivia 19,329 211 0.8 49 Guinea Bissau 3,272 206 19.1 50 Ghana 45,328 205 12.2

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Figure 3 – 1: Estimated TB incidence rates – WHO (2005)

Source: WHO Report 2007: Global TB Control Surveillance, Planning, Financing

Figure 3 – 2: Estimated TB/AIDS co-infection rates – WHO (2005)

Source: WHO Report 2007: Global TB Control Surveillance, Planning, Financing

Figure 3 – 3: Progress in high burden countries

Areas with high HIV prevalence in TB cases

Areas with high HIV prevalence in TB cases

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Source: WHO Report 2007

Figure 3 – 4: Aid priority countries of TB control and JICA’s cooperation outcome

TB high burden countries (22 countries) Icidence rate ≧280 TB high burden countries: Incidence rate ≧280

Treatment success (%)

Case Detection Rate (%)

JICA’s cooperation Technical cooperation /(Advisor) Dispatch of JOCV Training in Japan Grant aid

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3 – 1 – 2: Place an emphasis on the strengthening the quality of DOTS JICA renders cooperation to capacity development through the expansion and strengthening of the DOTS strategy, which are the goals of MDGs and the HDI, so that the government of the recipient country will be able to achieve a “case detection rate of 70% of estimated sputum smear-positive patients and a treatment success rate of 85% of sputum smear-positive patients.” In particular, JICA adopts an approach to increase the case detection rate while maintaining a high treatment success rate by making the maximum use of the strategies unique to DOTS. (Prevention of multidrug-resistant tuberculosis – Please refer to Chapter 2: 2 – 2 – 2 “(1) Multidrug-resistant TB control.) JICA will focus upon the following measures: 3 – 1 – 3: Support the Beyond DOTS strategy From the perspective of human security, JICA supports measures to deliver TB control services to people who have difficult accessibility to public health and medical facilities. In the past, JICA rendered cooperation to Community DOTS, urban tuberculosis control, TB/HIV control measures, the implementation of a model project for PPM, and the formulation of guidelines and capacity development through OJT at the model site so that the NTP would acquire the management capacity of the Beyond DOTS strategy. Such cooperation has manifested excellent effects. As discussed in Chapter 2, the Beyond DOTS strategy contains measures to further scale up the DOTS strategy. Thus, efforts should be made to improve the

2. Key approaches in strengthening the quality of DOTS To reach the MDGs, JICA will take an approach that focuses upon the following issues so that the government of the recipient country will be able to expand the DOTS strategy and achieve the improvement of case detection rate while maintaining a high treatment success rate.

(1) To improve monitoring, evaluation and supervision under the national tuberculosis program Capacity building that enables the government of the recipient country to track down problems and operate the program while solving the problems on its own

(2) Improvements in the system of sputum microscopy and external quality assurance in the area of laboratory To improve sputum smear microscopy, which forms the foundation of TB control: To introduce and improve a management system of external quality assurance to control the quality

(3) To strengthen the logistics system of anti-tuberculosis drugs and testing reagents etc.

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quality of DOTS, which is at the heart of TB control, and only when it is certain that a given level of the quality of DOTS can be maintained, various measures should be adopted under the Beyond DOTS strategy. In some countries, related governmental organizations lack the ability to coordinate aid from donors. There are cases in which the Beyond DOTS strategy must be started in parallel with the maintenance and expansion of DOTS even though it has not been properly introduced and expanded. Thanks to the inflow of a large amount of money from the GFATM, etc., it is now easier to implement some of the Beyond DOTS strategies with support from international organizations or aid organizations than before when the government was carrying them out with its own budget. In countries or regions where the basic DOTS strategy has not been firmly established, there are a few foreseeable risk factors. For instance, one is that DOTS may be carried out in a form with a high probability of treatment failure. Another is that the payment of salaries to volunteers at the peripheral level and funding to NGOs will build a new medical service system in parallel with the existing public medical services, thereby incurring the risk of preventing the development of the public medical service system of the recipient country. It will be essential, therefore, to pay due consideration to these issues when cooperation is rendered. 3 – 2: Notes concerning JICA’s cooperation policy on TB control As for the approach to cooperation to “qualitative strengthening of DOTS” and “support Beyond DOTS to scale up DOTS” in aid priority countries, the following issues will be focused on, based upon JICA’s past experiences of providing cooperation to many countries. <Notes concerning the JICA’s cooperation policy on TB control> 1. To focus upon capacity development through human resource development and

system building 2. To pay special attention to ensure sustainability of maintaining and improving the

quality entailed in the TB control project 3. To introduce a system tailored for each country based upon the outcome obtained

from implementing a model project 4. To provide cooperation in accordance with the conditions of each aid priority

country by making the maximum use of the features of each scheme 5. To render cooperation in closer coordination with international organizations and

aid organizations

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3 – 2 – 1: Cooperation primarily for human resource development, institution building, and system building (i.e., capacity development)

Capacity development is one of the approaches to which JICA gives special weight and has a comparative advantage relative to other international organizations and aid organizations. Hence, it is a matter of course that it is of great importance in TB control as well, and the approach will play the pivotal role. That is, JICA will provide cooperation to the development of human resources related to governmental organizations, system building such as DOTS and Beyond DOTS, and institution building in which the national tuberculosis program is reinforced so that TB control can be carried out properly in the country. 3 – 2 – 2: Secure the sustainability of the quality maintenance and improvement

entailed in the TB control project The viewpoint of sustainability is a key part of any of JICA’s cooperation. The DOTS strategy entails, so to speak, a built-in mechanism to detect and correct a malfunction in TB control. JICA executes cooperation primarily for building a system of monitoring, evaluation, and supervision simplified to meet the conditions of each country and the development of human resources and institutions that are responsible for external quality assurance. 3 – 2 – 3: Introduce a system modified for each country through implementing a

model project, etc. DOTS and Beyond DOTS are universal concepts. However, these concepts need to be modified in accordance with the budget, human resources, and health administration system of each country. JICA’s cooperation will aim to build a sustainable and appropriate system by making the maximum use of the limited resources of each country based upon the result of model projects etc. 3 – 2 – 4: Make full use of the advantages of each scheme for effective cooperation

It is expected that JICA will be able to render effective cooperation by integrating various schemes including technical cooperation project, grant aid, and training courses based on the past cooperation relevant to health, and in particular, tuberculosis.

In each aid priority country, JICA needs to select the best approach. There are countries whose country-specific assistance plans and cooperation programs state that TB control is a priority aid issue, whereas there are other countries where JICA has no office or where its cooperation infrastructure is limited. Thus, depending upon the conditions of each country, JICA needs to opt for either a selective combination of the

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above schemes or cooperation that primarily focuses upon the training course. In particular, in the case when all the above conditions to offer cooperation to

TB control are met, a technical cooperation program has a significant advantage in impacting on policy making at the national level of the national tuberculosis control program responsible for policy formulation and implementation. The core of the program being a technical cooperation project, the whole program must be operated in good coordination with other schemes. This form of program will be promoted because it has been proven highly effective. Figure 3 – 5: Effective cooperation with full use of the features of each scheme 3 – 2 – 5: Cooperation in closer partnership with international organizations and

aid organizations A massive amount of input is essential for strengthening nationwide TB control. That is, it is difficult to strengthen the TB control of any country only through capacity development, which typically characterizes JICA’s cooperation, unless some creative

1. Formulation of TB control plan and progress management

2. Formulation of guidelines and training module

3. Monitoring, evaluation and supervision (Implementation of DOTS: Lab. External Quality Assuarance) 4. Logistics

National TB program

Province/prefectur

County official in charge of TB

Tuberculosis patients

Health center

Rural area

Health center

Village health volunteers, etc.

Urban district

Private medical facilities, pharmacies

Community DOTS

DOTS PPP, PPM

Grant aid ・Construction of a TB center or central TB center ・Provision of anti-TB drugs and microscopes ・Anti-TB drugs ・Microscopes

Aid

to N

GO

s by

loca

l ope

ratio

n ex

pens

es fo

r the

pro

ject

(for

mer

co

mm

unity

em

pow

erm

ent

supp

ort)

Tec

hnic

al c

oope

ratio

n pr

ojec

t

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ideas are added to designing the cooperation. Hence, it will be important to effectively strengthen the national tuberculosis program in partnership with many related donors. JICA has accumulated experience, produced excellent effects, and has a comparative advantage in supporting the entire national TB program, and the formulation of guidelines and training modules through a pilot project. Thus, towards the eventual aim of nationwide reinforcement, it has been effective to form partnerships with other donors which offer aid to scale up DOTS at the county level. In the case of nationwide cooperation, JICA has supported monitoring, evaluation, and supervision of projects towards quantitative expansion of operation while maintaining the quality of the DOTS strategy. These approaches have proven effective and should be expedited in the future (Figure 3 – 6).

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Figure 3 – 6: Example for strengthening partnership with international organizations and aid organizations

Conferences hosted by the national tuberculosis program (the field for adjustments)

Workshop (sharing information among donors)

Cooperation for organizing a conference in which all related donors participate under the initiative of the national tuberculosis program

1. Formulate a TB control program and progress management

2. Formulate guidelines and training modules

3. Monitoring, evaluation, and supervision (Implement DOTS; LAB external quality assurance)

4. Logistics

JIC

A’s t

echn

ical

Coo

pera

tion

Proj

ect

National TB program

Province/prefecture

County official in charge of TB

Tuberculosis patients

Rural area

Health center

Village health volunteers, etc

Community DOTS

Health center

DOTS

Urban district

Private medical facilities,

pharmacies

PPP, PPM

WHO support for the formulation of guidelines

Financial aid from the GFATM

Financial aid per district from the common basket

Food supply to TB patients under treatment from the WFP

Support for the implementation to NGOs from USAID

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3 – 3: Issues concerning the execution of JICA’s cooperation policy on TB control The problem of TB still imposes a heavy burden upon developing countries. Yet, the global goals to eradicate TB have not been achieved. There is great need for cooperation in the future. This chapter looks into JICA’s cooperation policy on tuberculosis and relevant notes to be kept in mind in “3 – 1” and “3 – 2.” <Issues concerning the execution of JICA’s cooperation policy for TB control> ■Strengthen the implementation system 1. A cooperation program to meet the needs and conditions of each country should be systematized. ・Measures for new schemes of cooperation in DOTS ・Measures for sub-Saharan Africa and countries after the end of civil war ・Effective use of loans 2. Input resources must be developed and strengthened. 3. Information collection and transmission must be strengthened. 4. The implementation system to deal with new issues needs to be strengthened. 3 – 3 – 1: To systematize cooperation programs to meet the needs and conditions of

each country (1) Measures for new schemes of cooperation in DOTS

Since 1995 when DOTS was established, many countries have been taking measures, more or less, to carry out TB control under DOTS. It is assumed that JICA will receive requests under a new scheme of cooperation in the future as will be discussed below. Hence, JICA needs to refine its approach to satisfy the requests.

JICA does not have much experience in the areas discussed in this section. It is necessary to accumulate experience through the formulation and implementation of each project. 1) Cooperation for a specific region of a target country

Many countries have been already carrying out the DOTS strategy at the national level. In the future, therefore, it is considered that JICA will be requested to render cooperation to one component of DOTS in a specific region. Also, in all likelihood, the number of requests to provide cooperation to a specific region, rather than to the central government, will increase from countries where a federal system is adopted or decentralization has advanced. In this case, JICA needs to come up with a new idea on how to diffuse the

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benefits limited to the region of cooperation or the site of a model to other areas in the nation.

2) Partial cooperation for DOTS It is likely that JICA will receive requests to provide cooperation to the sector of laboratory and diagnosis, which is one of the components of DOTS, or to the strengthening of Community DOTS, urban tuberculosis, or PPM, which comes under Beyond DOTS. All these cases cover only a part of TB control measures. Hence, it is essential how JICA will be able to provide cooperation in coordination with national tuberculosis control.

(2) Measures for sub-Saharan Africa and countries after the end of civil war

1) Sub-Saharan Africa (TB/HIV control) The countries with high estimated TB incidence among aid priority countries

fall in line with the counties in sub-Saharan Africa with high HIV infection rates. Thus, there is great need for cooperation in the countries in this region because their general infectious disease control measures lag behind. JICA has some experience in extending technical cooperation projects to the laboratory in TB control in sub-Saharan Africa. However, cooperation has been primarily directed to training health personnel in Japan. In the future, it is important to understand the characteristics of each region in order to strengthen JICA’s cooperation system in sub-Saharan Africa. For instance, SWAPs, common basket, and decentralization have been introduced in a number of countries. As a result, cooperation is now given to strengthen the county’s health service system and funds are also funneled into the county. (Recently, a change is ongoing to replace sector-based funding with nation-based funding. However, the fact remains that the powers to implement projects have been transferred to the county, which is an administrative unit of health administration.) Among donor countries that promote SWAPs, TB control and AIDS control are handled as a vertical program. In countries where TB control functions successfully under the vertical program, their central governments attach importance to monitoring, evaluation, and supervision toward lower administrative organizations in the prefecture or county in order to maintain a high quality of DOTS throughout the nation. As a result, the TB control capacity of the prefecture and county has been standardized at a high standard. In sub-Saharan Africa, on the other hand, the central government is not much involved in lower administrative organizations. In the technical cooperation projects that JICA implemented in countries other than those in sub-Saharan Africa, its counterpart was the central government

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(TB Control Div. or Infection Disease Control Div. of the Ministry of Health) based upon the reasoning that importance lies in the monitoring, evaluation, and supervision for the quality control of DOTS in order for the government of the recipient country to improve the quality of TB control. However, in sub-Saharan Africa, the central government’s authority has been restricted, and moreover, the outflow of personnel has been on the increase in parallel with decentralization, thereby thinning out the personnel that formed the main layer of JICA’s counterparts. In some cases, technical cooperation project receives a negative response from other related donors and from the government of the recipient country where the common basket has been applied. Thus, it is difficult to render cooperation using the schemes or designs adopted for Asian countries. It is necessary to incorporate new ideas. The key to cooperation in the future lies in the way in which the function to monitor, evaluate, and supervise the quality of DOTS is incorporated into the DOTS strategy currently implemented in the county.

<Possible schemes of cooperation>

① To build a management system (monitoring, evaluation, and supervision system) of the TB control system at the county level under decentralization

② To offer cooperation to the central government focusing upon collecting good practice at the local or field (county) level ➝ Support for systemization ➝ Support for dissemination

③ To select a specific field of TB control and then build good practice at the local/county level ➝ Support for systematization ➝ Support for dissemination

④ To render cooperation to TB control as part of the development of public health and regional medical systems

2) Countries after the end of civil war In such countries as Cambodia and Afghanistan where TB control has been neglected for a prolonged period of time among aid priority countries, the number and incidence rate of TB-infected persons have been on the increase. Immediately after the end of civil war, a country is faced with problems: the health and medical system is fragile; there are many security restrictions; and aid is conducted under special conditions where NGOs take over a public medical system such as contract-in/out.46 Thus, it is required to formulate a project

46 This is an approach in which an NGO is commissioned to deliver health and medical services in a health administrative district. The content of the services varies by country, but the NGO, consignee, receives a commission in a lump sum, with which the NGO procures the necessary materials and pays wages to health workers (which is decided based upon the standard set from the perspective of whether or not it is enough to sustain livelihood

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considering which scheme of cooperation is most suited to the conditions of each country. On the other hand, there is great need for other disease control as well as TB

control in these countries. Hence, it is essential to examine the possibility of cooperation based upon cooperation priority in the entire field of health and the features of TB control and add new ideas to schemes of cooperation. One particular feature of TB control is that half measures only cause more serious TB damage. Thus, it is essential to take measures to strengthen TB control with the following points in mind: it takes a period of 6~8 months for medication for a patient to be treated; during this period, medical professionals must thoroughly follow TB-infected persons; and if there is no follow-up system, drug-resistant TB may spread extensively. For instance, during the emergency rehabilitation period immediately ensuing the end of civil war, it is possible to formulate a program in partnership with related NGOs, consignees of contract-in/out (responsible for delivering health administration services at the county level), and international development fiancé organizations (in particular, the Japan Social Development Fund of the WB and the Japan Fund for Poverty Reduction of the ADB).

(3) Collaboration with loans

Together with reforms in Japan’s ODA implementation system, JICA needs to pave the way for the full utilization of yen loans by paying greater attention to their more effective and inclusive use. In the area of TB control, JICA has experience in forming partnerships with international fiancé organizations such as the WB and ADB in strengthening the supply of anti-tuberculosis drugs. JICA has also worked in collaboration with health sector-based loans. Upon formulating a project for this area, the relevance is explained based upon the reasoning that people’s improved health conditions will eventually lead to alleviating declining GDP although the direct reimbursement of expenses cannot be expected, unlike toll roads and electric power plants. It will be important to collect and analyze information on these cases.

3 – 3 – 2: Development and strengthening of input resources It is assumed that requests for cooperation will increase in number and may change in content in the future. It is urgently required to expand human resources. or whether a worker is able to devote him/herself to his/her work as opposed to the wages of public officials which are normally kept low). The approach has validity during a postwar emergency rehabilitation period, but may foment dependency in terms of the payment of wages and in developing the capacity of the county administration and management that should essentially be responsible for providing these health services.

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The Issue-based Department should standardize the Plan of Operation for improving the quality of DOTS and Beyond DOTS and clarify the contents of work required for each expert and the time of dispatch. Based upon the outcome, it needs to find and develop the necessary human resources. As regards the development of new projects in the future, as discussed above, it is believed that JICA will receive an increasing number of requests to provide cooperation to TB control in a part of a region or an area as well as the entire national tuberculosis project. It is important to analyze and standardize the feasible contents of cooperation and to explore and develop human resources who are able to fulfill these requirements. JICA has been in the middle of expediting reforms subsequent to its reorganization as an independent administrative corporation. That is, JICA aims to achieve more efficient implementation of projects and greater performance. At present, the Issue-based Department has also been promoting raising efficiency in its medium-range plan. As one approach, it proposes and promotes technical cooperation project under contract with a private organization. 3 – 3 – 3: To strengthen information collection and transmission concerning DOTS As explained in Chapter 1, the Stop TB Partnership has been playing the pivotal role in international cooperation in the area of tuberculosis. In the past, JICA took many opportunities to dispatch experts of projects carried out in various countries to the meetings of the Stop TB Partnership. In the future, JICA should take the role of transmitting information in the area of health as well as tuberculosis on every occasion including international conferences. In particular, based upon the conditions of counterparts learning from experience in cooperation projects in many countries, JICA should stress the importance of DOTS strategy at the core of TB control. JICA has been aware of the significance of the basic DOTS strategy and has, in fact, produced a good outcome in many countries. Since the time when more funds started to come into the area of HIV/AIDS control, there are cases here and there in which the basic DOTS is neglected. There is a movement to draw international cooperation, for instance, by giving a new attention-getting name to a component constituting TB control. This movement is a measure for developing countries in want of various resources to obtain new input, and cannot be totally denied because it has elements that contribute to strengthening TB control. On the other hand, from the viewpoint of sustainability, it is essential to continue cooperation that is based on the recognition that the Beyond DOTS strategy can be built upon the DOTS strategy underlying TB control, as has been done by JICA. For instance, the expansion of TB control under the circumstances in which the treatment success rate is still low may end up in an epidemic of multidrug-resistant tuberculosis.

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In the field in many countries, international aid coordination and donor meetings are frequently carried out in the areas of health and infectious disease control. Each of JICA’s offices has been taking an active part in them. The project side has been asserting the importance of DOTS in the field and aid coordination meetings for TB control. In the future, it will be necessary for JICA to take a step forward. That is, it should increase opportunities to emphasize more strongly the importance of aid to the DOTS strategy through making a summary report of JICA’s cooperation at international conferences. 3 – 3 – 4: To strengthen the implementation system to address new challenges In order to address the issues discussed in the Sections “3 – 3 – 1” to “3 – 3 – 3,” it is essential to strengthen the Issue-based Department, overseas offices, experts, and contract organizations further. Since the start of the GFATM, the area of tuberculosis has been undergoing changes in the concept of public health: from a global viewpoint, it is expected that there may be a considerable change in the DOTS strategy due to new anti-tuberculosis drugs and testing reagents under development; and striking and rapid changes have been already taking place including control for super strains of multidrug-resistant tuberculosis that goes beyond MDR-TB and HIV/AIDS control measures. Additionally, an international coordination system has been further strengthened. JICA needs to explore how it will be able to reinforce its implementation system. For instance, it should have a good grip on global standards and trends and effectively incorporate them into its cooperation; it should consider the possibility of establishing an issue-specific committee for health and medicine (tuberculosis) constituted of Japan’s related organizations and resources for the purpose of transmitting JICA’s cooperation policy.

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<Bibliography> 1. Masakazu Aoki: Tuberculosis science for physicians and nurses 1 – Basic knowledge

(Revised in 2004), Japan Anti-tuberculosis Association: 2004 2. Masakazu Aoki: Tuberculosis science for physicians and nurses 3 – Principles and practice

of chemotherapy①, Japan Anti-tuberculosis Association: 2004 3. Masakazu Aoki: Tuberculosis science for physicians and nurses 4 – Principles and practice

of chemotherapy②, Japan Anti-tuberculosis Association: 2004 4. Masakazu Aoki: Visual Note on Basic Knowledge of Tuberculosis (Revised in 2001), Japan

Anti-tuberculosis Association: 2001 5. Naomi Toyokichi: Conditions and leadership in cooperation to Health SWAPs – Based upon

a case study of SWAPs in Ghana (Report by JICA’s Associate researcher: 2002) 6. WHO Report 2005: Global TB Control Surveillance, Planning, Financing 7. AIDS Clinical Center, International Medical Center o Japan: Support to Anti-HIV therapy

and medication: 2002 8. WPRO/WHO: Reaching the poor; challenges for the TB programmes in the Western Pacific

Region. 2004 9. ICMR Bulletin: Tuberculosis and Poverty. Vol. 32 No. 3 March, 2002. ISSN 0377-4910 10. WHO: A human rights approach to TB. Stop TB Guidelines for Social Mobilization.

WHO/CDS/STB/2001.9

<Homepage> Tuberculosis Fact sheet N°104 (Revised March 2006) http://www.who.int/mediacentre/factsheets/fs104/en/#infection Stop TB Partnership http://www.stopth.org/ The International Union against Tuberculosis and Lung Disease http://www.iuatld.org/full_text/en/frameset/frameset.phtml Global Fund to Fight AIDS, Tuberculosis and Malaria (FGATM) http://222.theglobalfund.org/en

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Appendix 1: Major examples of cooperation Appendix 2: Basic check items

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Appendix 1: Major examples of cooperation Table A1 – 1: Projects of project-type technical cooperation in the area of TB control

Country

Name of project

Duration

Content and characteristics

Afghanistan TB control project 2004-2009 To promote the national TB control project, primarily in disseminating DOTS through strengthening NTP and NTI in partnership with other donors and NGOs, cooperation for processes of formulating National. TB Strategy, guidelines, annual plan at the government level.

TB control project (Phase 1)

1987-1994 Assistance for the integration of the Nepal National Tuberculosis Control Program in collaboration with the construction of the National Tuberculosis Center (Kathmandu) and the Regional Tuberculosis Center (Pokhara) with grant aid

TB control project (Phase 2)

1994-1999 Technical cooperation for the implementation of DOTS by using the existing health system at the model site and designing a DOTS model in mountainous regions that are not easily accessible geographically

Nepal

Community tuberculosis and lung health project (Phase 3)

2000-2005 To ensure medical treatment under the DOTS strategy through strengthening the referral system and expanding diagnostic and treatment bases: To build a model for urban tuberculosis control in Kathmandu: To carry out various activities including acute respiratory tract infectious disease control among children through IMCI under the DOTS strategy

Public health project 1992-1997 A model project to introduce DOTS in the Province of Cebu

TB control project 1997-2002 Cooperation for the nationwide operation, based upon the above project

Philippines

TB control improvement project

2002-2007 To operate the monitoring, evaluation, and supervision system and the laboratory network system nationwide: To show how to supervise NTP in regions where the performance of DOTS is poor

Solomon Islands

Primary health care promotion project

1991-1996 To strengthen the health system using the approach taken in PHC: To develop human resources in the area of health and medicine: To enhance health education: To control infectious diseases including malaria and TB through C/P training

TB control project (Phase 1)

1983-1992 To build the foundation of the TB control system, thereby contributing to detecting TB patients

TB control project (Phase 2)

1993-1998 The project was temporarily interrupted because of civil conflict. The DOTS strategy that was introduced after its resumption produced a marked improvement in treatment success in the model region.

Yemen

TB control project (Phase 3)

1999-2004 To strengthen the laboratory service network in order to expand national tuberculosis services nationally: To improve TB treatment by proper management of patients: To improve the supply system of medicines by establishing a stock control system: To improve the monitoring system by standardizing the record-keeping and reporting system

Cambodia TB control project (Phase 1)

2000-2004 To expand the DOTS services to the health center: To strengthen TB/HIV control: To take measures for Community DOTS

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TB control project (Phase 2)

2004-2009 To address the issue of PPM mainly in Phnom Penh: To improve the quality of DOTS: To strengthen TB/HIV control measures

Zambia AIDS and TB control project

2001-2006 To provide assistance to the laboratory at Zambia University Teaching Hospital: To carry out research for making a policy proposal concerning TB/HIV control measures: To strengthen the examination function for external quality control of sputum smear microscopy

Myanmar Project for infectious disease control

2005-2010 To visit each community and play a guiding role in improving the quality of DOTS: To develop and disseminate a TB control module at the township level: To hold training for laboratory technicians: To spread knowledge about TB control to the family and community: To build relationships with private medical facilities: To formulate and distribute a DOTS handbook

Pakistan TB control project 2006-2009 To improve the monitoring and evaluation of DOTS implemented by the central and state governments focusing upon the State of Punjab and the TB program carried out by the Ministry of Health: It is planned to render cooperation for improving the supervising method, sputum microscopy, and quality assurance

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Table A1 – 2: Grant aid projects for TB control

Project

Fiscal year

Amount

Content

Collaboration with project- type coop.

Indonesia: Project for the Improvement of Medical Equipment at Persahabatan Hospital

1994 259 million

Equipment to upgrade TB diagnosis (CT scanner, clinical biochemistry analyzer, radiography, gynecological laparoscopy, thoracoscopy, bronchoscopy, and compact ultrasonic diagnostic apparatus)

(Long-term expert)

Cambodia: Project for Infectious Disease Control

2003 395 million

Purchase of anti-tuberculosis drugs, vaccines, and cold chain

Cambodia: Project for Infectious Disease Control

2004 232 million

Procurement of anti-tuberculosis drugs ●

Cambodia: Project for Infectious Disease Control

2005 278 million

Procurement of anti-tuberculosis drugs ●

Cambodia: Project for Improvement of the National Tuberculosis Center in the Kingdom of Cambodia

1999 803 million

Remodeling of the facilities of the National Tuberculosis Center

Nepal: Project for the Construction of the National Tuberculosis Center

1987 1,431 million

Construction of the National Tuberculosis Center and Community Tuberculosis Center

Haiti: Project for Improvement of Medical Equipment

1984 320 million

Haiti: Project for Tuberculosis Elimination

1981 600 million

Construction of the Tuberculosis Control Center and Cigno Sanatorium

Bangladesh: Project for Improvement of Medical Equipment

1987 681 million

Medical equipment and vehicles for health centers such as the tuberculosis HQ, research/training institute, and tuberculosis center

Philippines: Project for the Establishment of the National Tuberculosis Institute

2000 415 million

Construction of the National Tuberculosis Institute and provision of equipment

China: Project for Improvement of Equipment for the Tibet Tuberculosis Control Center

1994 709 million

Radiography, spectroscopy, endoscopy, medical check-up vehicle, and computers

China: Project for Tuberculosis Control in Poor Areas (Phase II)

2002 402 million

Purchase of anti-tuberculosis drugs and laboratory equipment in nine provinces and three autonomous districts

China: Project for Tuberculosis Control in Poor Areas (Phase III)

2003 449 million

Purchase of anti-tuberculosis drugs and laboratory equipment in nine provinces and three autonomous districts

China: Project for Tuberculosis Control in Poor Areas (Phase IV)

2004 405 million

Purchase of anti-tuberculosis drugs and laboratory equipment in nine provinces and three autonomous districts

China: Project for Tuberculosis Control in Poor Areas

2000 321 million

Purchase of anti-tuberculosis drugs and laboratory equipment in nine provinces and three autonomous districts

Honduras: Project for Improving Medical Equipment at the National Health Laboratory

2004 146 million

Procurement of clinical laboratory equipment for the central and regional laboratories to strengthen clinical testing capacity for infectious disease surveillance

Zambia: Infectious Disease Control Project

2003 51 million

Procurement of anti-tuberculosis drugs and reagents and health center kits (diagnostic toolbox) for diagnostic tests

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Zambia: Infectious Disease Control Project (Phase II)

2004 415 million

Procurement of reagents for diagnostic tests

Swaziland: Project for Improving Health Care Service

1997 415 million

Procurement of medical equipment for the Tuberculosis Center (medical equipment and X-ray film viewers used at Clinical Laboratory and Radiography Dept.)

Swaziland: Project for Improving Health Care Service

1999 161 million

Procurement of medical equipment for the Tuberculosis Center (medical equipment and X-ray film viewers used at Clinical Laboratory and Radiography Dept.)

Afghanistan: National Tuberculosis Control Project

1977 75 million

Construction of the National Tuberculosis Institute and the Tuberculosis Center

Armenia: Project for Improvement of Medical Equipment

2001 495 million

Provision of medical equipment to the Republic TB Hospital

Yemen: Project for Expansion of the National Tuberculosis Center

1984 918 million

Construction of the Tuberculosis Center ●

Yemen: Project for Expansion of the National Tuberculosis Center

1985 108 million

Construction of the Tuberculosis Center ●

Yemen: Project for Expansion of the National Tuberculosis Control Program

1991 508 million

Remodeling of the TB sub-center and procurement of medical equipment for it

Yemen: Project for Expansion of Tuberculosis Control in the Southern Govemorate

2000 564 million

Facilities for education/training for persons involved in TB control and Mycobacterium testing and researches (Aden)

Yemen: Project for Expansion of Tuberculosis Control in the Southern Govemorate

2002 589 million

Education/training facilities for persons involved in TB control and diagnostic tests and researches (Aden)

Note: BCG is excluded from the above list because it is included in the EPI project.

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Table A1 – 3: Dispatch of JOCV members for strengthening TB control

Country Duration of dispatch

Occupation Content of request (including plans) Workplace assigned to the volunteer

Honduras 1991.12 ~1993.12

Public health nurse

There is one district hospital and 13 health centers in the Department of Gracias a Dios in the northern part of Honduras. This is the most underdeveloped area. The JOCV member is expected to give education to practical nurses working in the area on heath activities, health statistics, and infectious disease control (especially TB).

The First Hygiene Region, Ministry of Health and Social Welfare

Bangladesh 1992.7 ~1994.7

Public health nurse

It is expected to give health education to patients and staff at the central organizations related to TB. Responsibilities include making a plan, enforcing the plan, and preparing teaching materials. The JOCV nurse visits 42 TB clinics in local areas and trains instructors (unlicensed)

Tuberculosis Prevention Center, Ministry of Health and Family Welfare

Guatemala 1992.1 ~ 1995.1

Nurse It is expected to show nine registered nurses and 106 practical nurses in the hospital how to give nursing care and treatment to TB patients and ICU patients. It is also expected to hold lectures and study groups to impart knowledge of nursing, thereby raising the level of awareness about nursing.

San Vicente TB Hospital, Ministry of Welfare

Samoa 1992.1 ~ 1996.1

Clinical laboratory technologist

Responsibilities include the establishment of diagnostic tests (ZN coloring and identification in bacterial culture) in the Bacteriology Section of the Laboratory at the National Central Hospital, carrying out routine bacteriology, and teaching the techniques to students.

National Hospital, Ministry of Health

Bangladesh 1992.1 ~ 1994.12

Public health nurse

It is expected to give health education to patients and staff at the central organizations related to TB control. Responsibilities include making a plan, enforcing the plan, and preparing teaching materials. The JOCV nurse needs to visit 42 TB clinics in local areas and train instructors (unlicensed).

Tuberculosis Prevention Center, Ministry of Health and Family Welfare

Bangladesh 1992.12 ~1994.12

Clinical laboratory technologist

It is expected to give education to laboratory technologists primarily at the center (on bacteriological testing). The JOCV member is also expected to visit, together with nurses who go for their nursing activities, local areas to teach local laboratory technicians. The laboratories are well equipped with equipment and supplies provided by Japan. It is expected to teach the techniques of culture and resistance tests of tubercle bacilli.

Tuberculosis Prevention Center, Ministry of Health and Family Welfare

Ivory Coast 1993.4 ~ 1995.4

Public health nurse

The JOCV member is assigned to Pakobo Clinic under the jurisdiction of the Medical Office in the Tiassale region with a JOCV midwife. It is expected to carry out clinical activities in cooperation with local nurses. He/she will also visit villages within a range of 15 km and provide medical service and vaccination as well as

Medical Office in Tiassale, Ministry of Health and Welfare

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teaching control measures of endemic diseases (leprosy, TB, and onchocerciasis) and hygiene.

Honduras 1993.7 ~ 1995.7

Public health nurse

Infectious diseases in general: It is expected to spread knowledge and skills about infectious disease control, particularly TB, acute respiratory infectious diseases, cholera, and AIDS, to community practical nurses, midwives, health volunteer workers, and residents, individually or in groups: Especially requested is cooperation for TB control.

The First Hygiene Region, Ministry of Public Health and Social Welfare

Ivory Coast 1993.1 ~ 1995.12

Clinical laboratory technologist

The JOCV member is assigned to the Medical Office in the Tiassale region to carry out routine laboratory activities and enhance the function of the laboratory. The Office is responsible for endemic diseases (leprosy, TB, onchocerciasis, and Schistosoma haematobium) control. Thus, he/she will conduct sputum, blood, and urine tests related to these diseases.

Medical Office in Tiassale, Ministry of Health and Welfare

Solomon Islands

1994.4 ~ 1995.1

Nurse It is expected to conduct diagnosis, treatment (including suture), checkup on pregnant women and infants, vaccination, and follow-up of TB patients at the clinic within the Noro District Community Center. It is also expected to give education on health to community residents.

Noro Clinic, Government of Western Province

Malawi 1995.4 ~ 1997.7

Nurse The JOCV nurse is assigned to a Christian general hospital, with 170 beds in total, consisting of General Practice, Obstetrics, and a TB wing and also a nursing college. It is expected to teach and advise the staff about the management of pharmacy, inventory of medicines, and medication to outpatients and in-hospital patients. It is also to teach and advise the staff of the pharmacy about the supply of medicines at the health center in the district.

St. Joseph’s Hospital, Ministry of Health

Cambodia 1995.7 ~ 1997.7

Public health nurse

This cooperation constitutes a part of the rural development project provided through triangle cooperation with the four ASEAN countries (Indonesia, Malaysia, the Philippines, and Thailand). He/she is based at clinics in villages within the target area and carries out activities of teaching about public health including PHC, MCH, TB/malaria control, and ARI control to residents.

Ministry of Rural Development

Samoa 1995.1 ~ 1998.3

Clinical laboratory technologist

The Laboratory carries out mycobacterium tests (Z-N coloring and culture). It is expected to teach techniques to a local staff so that the Laboratory will be able to conduct tests including drug sensitivity tests.

Central Laboratory, National Hospital, Ministry of Health

Malawi 1996.4 ~ 1998.4

Clinical laboratory technologist

It is a general Christian hospital located within 20 km of Blantyre. It consists of General Practice, Obstetrics, and a TB wing. It is expected to raise the level of microscopic techniques (liver function, urine, and stool) through technical guidance and teaching the management of testing reagents to the staff.

Mulanje Mission Hospital, Ministry of Health

Dominican 1996.4 ~ Public health The Office has jurisdiction over public health and The Fourth Regional

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Republic 1998.4 nurse social welfare in the four provinces in the southwestern part. The JOCV nurse is expected to give medications and advice on living to TB patients, and visits hospitals and clinics for guidance. In cooperation with local nurses, he/she also teaches about family planning and provides vaccinations.

Office, Ministry of Health and Social Welfare

Honduras 1996.4 ~ 1998.4

Public health nurse

While working at the public health center under the jurisdiction of the Office, the JOCV member carries out public health extension activities including TB control to residents, health volunteers, and practical nurses who work at public health centers. Preventive education is provided individually or in groups depending upon the specific needs of each area.

The First Hygiene Regional Office, Ministry of Health

Paraguay 1996.4 ~ 1998.4

Public health nurse

The JOCV nurse is assigned to the Health Division of the Regional Medical Center and gives education to medical professionals and people involved in maternal and child health, TB control, and genital disease control, thereby enhancing the overall level of medical service in the Department of Paraguari.

Public Health Center in Paraguari, Ministry of Health

Solomon Islands

1997.7 ~ 1999.7

Nurse The Noro Clinic is responsible for the Noro District on New Georgia Island and neighboring islands. The JOCV nurse is engaged in diagnosis, drug prescription, treatment of slight wounds including suture for outpatients, checkup of pregnant women and checkup of infants, vaccinations, and follow-up of TB patients. She/he is also involved in regional health and health education.

Noro Clinic, Medicine and Welfare Bureau of Western Province

Dominican Republic

1997.7 ~ 1999.7

Public health nurse

The JOCV nurse carries out activities in public health to nurses of clinics and health extension workers in the region. He/she tries to expand local medical service based upon the national plan, “Improvements in TB control, expansion of inoculation, family planning, and maternal and child health.”

Office in Valverde D. N., Ministry of Welfare

Marshall 1997.7 ~ 1999.12

Nurse The JOCV nurse works at a general hospital in the capital (with 85 beds, 11 doctors, and 139 nursing members) and is engaged in daily clinical nursing together with the local staff so as to raise the level of nursing skills. The main diseases treated by Internal Medicine include diabetes, high blood pressure, pneumonia, and tuberculosis.

Majuro Hospital, Ministry of Health and Environment

Malawi 1998.4 ~ 2000.4

Clinical laboratory technologist

It is a general Christian hospital and consists of General Outpatients, Pediatrics, Surgery, Gynecology and Obstetrics, and a TB wing. It has 250 beds. In the hospital’s laboratory, the JOCV member supports its staff in blood, urine, stool, and marrow tests and bacteriological tests due to a high prevalence rate of infectious diseases.

Muranje Mission Hospital, Ministry of Health

Malawi 1998.1 ~ 2000.12

Public health nurse

The JOCV nurse carries out activities at the health center under the jurisdiction of the government’s local hospital equipped with 190 beds and

Lobi Health Center, Dedza District Hospital, Ministry of

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consisting of General Practice, Obstetrics, Pediatrics, and a TB wing. It is expected to improve residents’ nutrition and hygiene through teaching what and how should be cooked and eaten in order to expand the latitude of farmers.

Health

Bolivia 1998.1 ~ 2000.6

Public health nurse

The JOCV nurse is assigned to the only clinic in a village of about 1,000 people. He/she gives cooperation through holding lectures or visiting individual houses, together with his/her counterpart, on the health program, vaccination, TB control, and family planning.

San Isidro Clinic, Comarapa Hospital, Ministry of Health

Maldives 1999.4 ~ 2001.4

Clinical laboratory technologist

The JOCV member carries out laboratory work with an Indian technician and Maldivian assistant. The main tests include general urine tests, urinary sediments, general blood tests, parasites, tubercle bacilli, malaria, group bacterial drug sensitivity tests, group-bacilli drug sensitivity tests, and biochemical tests. It is also expected to train the assistant.

Male Local Hospital, Ministry of Health

Malawi 1999.4 ~ 2001.4

Pharmacist The hospital is a Christian general hospital with 178 beds and consisting of General Practice, Obstetrics, Pediatrics, and a TB wing. Malawi has a chronic shortage of pharmacists. The JOCV member, as the responsible person in charge of the pharmacy, extends cooperation in the procurement of medicines, inventory control, and dispensing of medicines (drugs dispensed at the counter and in the hospital).

St. Joseph’s Mission Hospital, Ministry of Health

Malawi 1999.4 ~ 2001.4

Clinical laboratory technologist

The JOCV member works at a Christian hospital (with 150 beds) located 80 km away in the west of the capital and trains local staff while carrying out daily tests. Tests primarily include microscopy of malaria and tubercle bacilli. The hospital plans to conduct bacterial culture. Thus, it wishes to have a JOCV member experienced in bacteriological testing.

St. Gabriels Mission Hospital, Ministry of Health

Malawi 1999.4 ~ 2001.4

Pharmacist It is a government-run central hospital equipped with 850 beds and General Practice, Obstetrics, Pediatrics, and a TB wing. The JOCV member works as an administrative pharmacist and looks into the best usage depending upon the conditions. Besides, he/she makes proposals and gives training to local staff. Also, he/she shows how to take an accurate inventory and estimate the required quantity of each drug for the proper purchase of medicines.

Malamulo Mission Hospital, Ministry of Health

Malawi 1999.4 ~ 2001.4

Physical therapist

The JOCV member is assigned to a government-run local hospital, with 163 beds, consisting of General Practice, Obstetrics, Pediatrics, and a TB wing. His/her main activities are akin to those in Japan in general. They include rehabilitation from hemiplegia caused by apoplexy or meningitis, broken bones by traffic accident, infantile paralysis, meningitis, and burns.

National Kasungu Hospital, Ministry of Health

Malawi 1999.4 ~ Physical The JOCV member is assigned to a National Lilongwe

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2000.10 therapist government-run central hospital, with 850 beds, consisting of General Practice, Obstetrics, Pediatrics, and a TB wing. His/her main activities are akin to those in Japan in general. They include rehabilitation from hemiplegia caused by apoplexy or meningitis, broken bones by traffic accident, infantile paralysis, meningitis, and burns.

Central Hospital, Ministry of Health

Malawi 2000.4 ~ 2002.4

Pharmacist It is a Christian hospital that has 262 beds and General Outpatients, Pediatrics, Surgery, Gynecology, and a TB wing. The JOCV member works as a pharmacist and is primarily responsible for the management of drugs and inventory control.

Muranje Mission Hospital, Ministry of Health

Malawi 2000.4 ~ 2002.4

Clinical laboratory technologist

It is a Christian hospital that has 262 beds and General Outpatients, Pediatrics, Surgery, Gynecology, and a TB wing. The JOCV member works as a clinical laboratory technologist. Basic knowledge and skills of testing in general are required.

Muranje Mission Hospital, Ministry of Health

Malawi 2000.7 ~ 2002.7

Pharmacist It is a Christian hospital with about 164 beds and is a medium-sized core hospital in the region. The wings consist of Men’s, Women’s, TB, and Pediatrics. The Outpatient Dept. treats all sorts of patients. The JOCV member is responsible for, in particular, inventory and the management of medical supplies.

Holy Family Mission Hospital, Ministry of Health

Malawi 2000.7 ~ 2002.7

Pharmacist It is a Christian hospital with about 230 beds consisting of General Outpatients, Surgery, Pediatrics, Gynecology and Obstetrics, Ophthalmology, and a TB wing. The JOCV member works as a pharmacist. He/she is chiefly in charge of counter work, inventory control, and ordering. A computer is used for the management of medical supplies. Hence, he/she is required to have the ability to teach the skills required.

Nkhoma Mission Hospital, Ministry of Health

Malawi 2001.4 ~ 2003.4

Physical therapist

It is a government-owned hospital with 163 beds that covers the entire area of Kasungu and consists of Men’s General Practice, Women’s General Practice, Obstetrics, Pediatrics, and a TB wing. The JOCV member primarily carries out rehabilitation from sequelae (or after effects) of cerebral vascular disorder and spinal cord injury. It is also important to give training to the hospital staff.

Kasungu District Hospital, Ministry of Health

Nepal 2001.7 ~ 2003.7

Public health nurse

The JOCV nurse is assigned to the city office of the city that is 450 km away from the capital. He/she is responsible for assisting the operation of six mobile community clinics in the city, maternal and child health, infectious disease control including TB, and planning a regional health program primarily comprising education and instruction to residents on public health.

Dharan City Office, Ministry of Local Development

Cambodia 2002.4 ~ 2003.1

Clinical laboratory

It is a general hospital with 415 beds and a staff of 375 (out of which 39 are physicians). In the

Laboratory, Svay Por District Referral

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technologist laboratory with a staff of ten technicians, the JOCV member gives advice on manual procedures of blood tests including blood cell counts and general urine tests. He/she is also requested to support the TB control program.

Hospital

Dominican Republic

2003.4 ~ 2005.4

Public health nurse

The JOCV member works at the provincial office in the area of the peninsula 250 km in the northeastern direction from the capital and offers cooperation to school health, expansion of immunization, and TB, dengue fever, and AIDS control by paying visits to the community and also by training of extension workers in the region. He/she becomes involved in the lives of the residents by and large. Hence, it is required that he/she has a broad view and a flexible way of thinking beyond the area of medicine.

Samaná Provincial Office, Ministry of Welfare

Botswana 2003.7 ~ 2005.7

Nutritionist The JOCV member carries out his/her activities as a dietician at a national primary hospital with 39 beds consisting of General Practice, TB, Obstetrics, Pediatrics, and a wing for a fee. It is required that he/she has basic knowledge and skills as a dietician and is also able to prepare a variety of nutritionally balanced dishes.

Thamaga Primary Hospital, Basic Health Bureau, Ministry of Health

Botswana 2004.4 ~ 2996.4

Nutritionist The JOCV member works as a dietician at a national primary hospital, with 65 beds, consisting of General Practice, TB, Obstetrics, Pediatrics, and a wing for a fee. It is required that he/she has basic knowledge and skills as a dietician and is able to prepare a variety of nutritionally balanced dishes.

Palapye Primary Hospital, Basic Health Bureau, Ministry of Health

Pakistan 2004.4 ~ 2006.4

Public health nurse

The JOCV nurse works at the education center (under the Ministry of Social Welfare) in a TB hospital (under the jurisdiction of the Ministry of Health) in Rawalpindi, a neighboring city of the capital. Patients who visit the hospital must receive counseling at the center. The JOCV member gives counseling on drugs and daily life.

Center for Tuberculosis Education, Ministry of Social Welfare and Special Education

Honduras 2004.7 ~ 2006.7

Infectious disease control

The JOCV member is assigned to a city located 300 km from the capital and works as a member of the district’s NGO. In the residential areas of African Hondurans in four districts, he/she carries out educational activities necessary for the control of AIDS, malaria, TB, and digestive organ infectious diseases. He/she also extends cooperation to enhance the collaborative system with community health centers.

Black Women’s Association of Honduras (NGO)

Honduras 2004.7 ~ 2006.7

Infectious disease control

The JOCV member is assigned to a city located 300 km from the capital and works as a member of the district’s NGO. In the residential areas of African Hondurans in four districts, he/she carries out educational activities necessary for the control of AIDS, malaria, TB, and digestive organ infectious diseases. He/she also extends cooperation to enhance the collaborative system with community health centers.

Black Women’s Association of Honduras (NGO)

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Pakistan 2004.1 ~ 2006.12

Public health nurse

The JOCV nurse becomes involved in activities for improvements in public health under the local development project (in health, hygiene, education, and juveniles) implemented by the Ministry of Social Welfare. He/she belongs to the project’s office in a village. He/she investigates regional needs and provides necessary information to residents through holding workshops (including education on TB control).

Local Development Project, Ministry of Social Welfare

Colombia 2005.7 ~ 2007.7

Clinical laboratory technologist

The JOCV member belongs to a hospital that handles about 830 specimens per day (more than half being blood tests) and carries out tests on urine, blood, immunology related, parasites, tubercle bacilli, HIV serum, biochemistry, and blood components (for transfusion), thereby contributing to raising the technical level of local laboratory technicians. A broad range of knowledge and techniques is required rather than advanced expertise.

Hospital San Juan de Dios, Provincial Ministry of Social Security

Zambia 2005.1 ~ 2007.11

Rural development extension worker

The JOCV member is assigned to an NGO that addresses the issues of occupational training and nutritional improvement among low-income residents in Lusaka. He/she formulates policies on 1) organizational management of the field staff of the TB control project (volunteer workers) and 2) collection and analysis of information associated with TB in the region. He/she is required to have knowledge on public health and hygiene.

AMDA Zambia (NGO), Ministry of Finance and National Planning

Gabon 2005.1 ~ 2007.11

Infectious disease control

In cooperation with the members of the Infectious Disease Control Team of the hospital, the JOCV member carries out the following activities: 1. to assist factual surveys on infectious diseases such as malaria, leprosy, TB, rabies, and hepatitis; 2. to give advice on the planning and assist the implementation of a preventive and education program; and 3. to give counseling to residents on infectious diseases.

Lambarene Local Hospital, Ministry of Health

Gabon 2005.1 ~ 2007.11

Public health nurse

In cooperation with the staff of the Institute, the JOCV member plans and manages the preventive and educational program concerning infectious diseases (malaria, AIDS, rabies, leprosy, and TB). Also, he/she helps organize a campaign for immunization, grasps the conditions of the health/hygiene of residents, and gives guidance on health management.

Institute of Infectious and Endemic Diseases Eradication, Ministry of Health

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Table A 1 – 4: Training courses in the area of TB control (Group training courses 1963 ~ 2004) Note)

Course

Background and objectives

Strategies of the course No. of

participants (countries)

Tuberculosis Laboratory Network for DOTS Expansion

Tuberculosis is still the leading infectious disease throughout the world. Under the flag of the WHO, DOTS expansion has been expedited. However, there are a number of problems in the quality improvement and accuracy control of bacteriological test, which is of overriding importance to diagnosis of patients and evaluation of the progress of treatment. In particular, it is essential to build a nation-wide tuberculosis laboratory network for effective DOTS expansion.

This course has been organized based upon experience obtained from the earlier course and TB projects carried out in many countries and also information from international organizations. Thus, the course aims to meet global needs in TB control. (The course has evolved from the course titled “TB control” established in 1963.)

The course consists of lectures, practical training, and study visits. (1) TB control program and the

roles of the Mycobacterium tuberculosis test

(2) Present state and problems of the M. tuberculosis test in TB control in developing countries

(3) Leadership training method and teaching method

(4) Evaluation of the laboratory and accuracy control of sputum smear microscopy

(5) Laboratory network and management in TB control

(6) Basic technology of the M. tuberculosis test

(7) Maintenance and operation of experimental equipment including microscopes

(8) Correct handling of experiments and experimental data

(9) Validation tests (10) Most advanced technology in

the M. tuberculosis test

242 persons (55 nations)

STOP TB Action Training Course

The course targets at doctors who are involved in the TB control program in developing countries. It provides training on recent TB control measures and aims at the development of human resources who have the capacity to promote and develop the TB control program using the most rational, realistic, and efficient approach under the social and economic conditions faced by their own countries. (The course has evolved from the original course titled “Laboratory works for TB control” established in 1976.)

The course consists of lectures, practical training, and study visits. (1) Basics of tuberculosis

(epidemiology, immunology, bacteriology, statistics, HIV and TB, management, and social, economic, and cultural aspects and hygiene education)

(2) National TB control (control measures in general, main components, TB and AIDS, research activities, and the WHO module)

(3) Epidemiological inquires (4) Formulation of action plans

830 persons (72 nations)

National Tuberculosis Program Management

The course introduces methodology on the implementation and evaluation of TB control programs at the national level to fight tuberculosis in developing countries. At the same time, its objective is to contribute to strengthening the program of each country through introducing the TB

The course consists of lectures, workshops, and study visits. (1) To learn the most recent TB

control approach (2) To learn TB control

improvement methods (3) To discuss various problems in

the implementation of a TB

404 persons (68 nations)

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control program of each participant’s country and exchanges of opinions. (The course has evolved out of the original course titled “To develop leaders in TB control (program management)” established in 1973.)

control program (4) To raise a common awareness

among participants in TB control

Note) Including the training courses specially offered

Table a 1 – 5: Training course in TB control (Country-specific training course)

Name of the course

Name of the project

Duration of cooperation

No. of

participants

Infectious disease

control

(TB and malaria)

Infectious disease control and public

health in Peru

1995 – 1996

23 persons

Table 1 – 6: Training course in TB control (Local in-country training course)

Name of the course

Outline of the course

(Name of the project)

Duration of cooperation

No. of

participants

Philippines: Supplementary

Project for TB Control for the

Poor

Supplementary Project for TB

Control in Poor Settlements in the

Philippines

(Local in-country training)

1998

26 persons

National TB control project Supplementary Project for TB

Control in Poor Settlements in the

Philippines

(Local in-country training)

1999 - 2002

223 persons

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Appendix 2: Basic check items Cooperation for TB control must follow the same procedures taken in any cooperation for the area of health and medicine. That is, prior to the selection of an approach, the first thing to do is to carry out a comprehensive analysis of the developmental conditions of the target country to explore the problems in the country’s area of health and to look into its priority sectors. In particular, TB control is built upon the infrastructure of the public health system. Hence, what is required is to have information on the public health system and its organizational chart and also on the degree to which the system functions. It is comparatively easy to convert data on TB into indicators, which means that there is greater availability of indicators. At the same time, it is also required to infer the conditions through indicators in the associated areas of health and medicine such as maternal and child health. The following table describes the check items. On how to use the following indicators, please refer to the knowledge site for presentation because there is a case in which they have been collected and presented in PowerPoint format prior to the dispatch of a preparatory evaluation study team. Basic check items

Check item/indicator

Unit/calculation method

Remarks

Entire area of health 1

National ten-year development planning, etc.

Analyze whether emphasis is placed upon the area of health and medicine or on which sector of health emphasis is placed from relationships with national strategies. Check the wage system of public officials and PRSP and also confirm whether the country has introduced the common basket.

2

Administrative structure and system

Check the degree of decentralization and the division of roles between the central government and local governments.

3 Financial conditions Proportion of expenditure spent in the area of health

4

National policy and strategy for health and medicine

Confirm the presence/absence of national policy on health and medicine for the following three to ten years and confirm how the areas of infectious disease control and TB control are delineated. In many countries, it is often the case that issues are merely inclusively listed. Hence, confirm whether these areas are clearly defined.

5 Finances of national health and medicine

Confirm the budgetary ratio appropriated to the area of tuberculosis.

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6

National health administrative structure and organizations

Same as the above 2.

7

Achievements and trends of cooperation from other donors

In particular, the WHO, GFATM, KNCV, and USAID

System of health administration 8 The number of health and

medical institutions by the referral system

Standards of establishment such as the number, population, and area

9 Personnel placement planning and actual placement

Medical workers allocated to each institution by type of occupation and number

10 Ratio of personnel expenses in expenditure for health

11 Presence/absence of a medical health system

Outline of the area of tuberculosis (1) Indicators to show burden 12 Incidence rate Ratio per 100,000

population of the estimated number of new TB patients per year

Prevalence rate Ratio per 100,00 population of the number of symptomatic TB patients at a given time

They are computed every five years from the national prevalence survey carried out by the WHO in earlier years in the country in question. They are projected on each category of smear-positive pulmonary TB and all forms of TB (smear-positive pulmonary TB, smear-negative pulmonary TB, and extrapulmonary TB).

(2) Indicators to show progress 14 Case detection rate It indicates the

number of TB patients detected out of the estimated number of TB patients in one country.

15 Cure rate It indicates the number of TB patients who have successfully completed the 6~8 month regimen.

16 DOTS coverage DOTS population coverage Percentage of population covered by DOTS

It indicates the percentage of population that has access to DOTS services.

Confirm ① case-finding rate, ② progress of cure rate, and ③ DOTS coverage towards attaining a case detection rate of 70% and a cure rate of 85%.

State of the public health system 17 Infantile mortality Mortality of babies

aged less than one year old/No. of births x 1,000

18 Mortality of children under the age of five

Death rate of children aged less

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than 5 years old/No. of births x 1,000

19 Mortality of pregnant women

Death rate of pregnant women/No. of births x 1,000

20 Main causes of death Top ten causes of death

21 Causes of death related to infectious diseases

Top five causes of death

22 Average life expectancy at birth

23 Percentage of deliveries attended by a medical professional

The number is used to assess the degree of penetration of the public health system.

24 Delivery rate at the medical institution

The number is used to assess the degree of penetration of the public health system.

25 Percentage of participation in pre- and post-delivery medical checkups

The recommended number of participations varies by each country. Use the number of the country in question. The ratio is used to confirm the degree of penetration of the public health system.

26 Mean annual population growth rate

27 Total population/population growth rate

28 Proportion of urban population

Calculate the percentage of urban population out of the total population of each country.

29 Literacy rate among adults Literate adults aged 15 or over/ population of people aged 15 or over

The percentage of people aged 15 or older who are able to read and write simple sentences used in everyday life while understanding the meaning.

30 Rate of enrollment in primary education

Number of children enrolled in primary education/population of primary school- aged children