GH Friedland, MD1

Tuberculosis and HIV

Models for TB programmes to contribute to the delivery of ART

What are the operational research questions?

Gerald Friedland, MDAIDS Program

Yale University School of Medicine

GH Friedland, MD2

• TB and HIV-two cultures• Minimal TB and HIV Program needs• Spectrum of collaboration/integration• Case studies• Operational research issues

Models of TB/HIV Care

GH Friedland, MD3

HIV/TB-Two Cultures

• TB culture: public health approach, with firmly established algorithms, fixed and standardized measures and outcomes

• TB services: geared for chronic care-but relatively short term, standardization, simplified regimen , epidemic control, difficulty with individual nuance and new TB diagnostic dilemmas with HIV disease

• HIV as an “intruder”: disrupting TB strategies andprograms

• HIV culture: individual patient and human rights approach, guidelines but no standardization, familiar with rapid treatment paradigm changes

• HIV services :clinically and patient oriented with only recent emerging public health practices; lifelong treatment, limited experience with TB treatment and public health approach

• TB as a challenge: discomfort with treatment in HIV setting

GH Friedland, MD4

• Comprehensiveness

• Continuity

• Competence

• Compassion

• Cost effectiveness

The Minimum for effective TB-HIV collaboration –

GH Friedland, MD5

The Minimum for effective TB-HIV collaboration – the TB side

• Counseling and Testing for to identify HIV infected• HIV/AIDS staff training/awareness• Co-trimoxazole prophylaxis for TB patients who are

HIV infected• Mechanism for referral for antiretroviral therapy for

TB-HIV co-infected patients who need it (?) • Primary and secondary HIV prevention education for

TB patients• Patient confidentiality

GH Friedland, MD6

• Active TB case finding for all HIV infected patients • TB staff training/awareness • Mechanism for referral for Dx and TB treatment(?)• Mechanism for continuation of HIV treatment• Tuberculin skin testing (TST) for HIV infected?• INH preventive therapy (IPT) for TST+• TB transmission prevention• Patient confidentiality

The Minimum for effective TB-HIV collaboration – the HIV side

GH Friedland, MD7

– Although delivery models differ, outcomes should be identical

– TB treatment success- cure/completion of therapy

– Reduction in HIV disease progression and mortality

– Decrease in transmission of both diseases

Models of TB/HIV CareOUTCOMES

GH Friedland, MD8

Need for many modelsOne model may not fit all countries

Differences in HIV and TB prevalenceDifferences in history, resources, culture, expertiseDifferences in feasibility

One model may not fit one country Urban vs. rural TB clinic vs. primary care clinic

Logical to maximize/exploit existing site infrastructureHospitals, clinics, existing TB DOTS and HIV VCT

programs, nascent HIV programs, availablehuman resources

Models of TB/HIV Care

GH Friedland, MD9

Current and Optimal TB and HIV Program Paradigms

Current TB and HIV Programs Paradigm

Optimal TB and HIV Programs Paradigm

National TB Program

HIV Services

VCTOI Px

AntiretroviralsAdherence Support

NationalHIV Program

NationalHIV Program

CommunicationCollaboration

TB Services

Sputum collectionDOT

Treatment SupportContact TracingLTBI Treatment

TB Services

Sputum collectionDOT

Treatment SupportContact TracingLTBI Treatment

HIV Services

VCTOI Px

AntiretroviralsAdherence Support

National TB Program

CommunicationCollaboration

GH Friedland, MD10

Which model of collaboration ?

TB HIV/AIDS

TB AIDS TB/AIDS

Separate

TB/ HIV patients referral

Full

One stop service for TB-HIV co-infected

TB AIDS

Partial

Some mixing

GH Friedland, MD11

1. HIV programs learn lessons from TB program with little to no integration of services

Malawi

2. TB programs serve as site for some integration and collaboration of services

START- Durban, Sizonqoba-Tugela Ferry

3. HIV and TB programs organized with full integration of services

Khayelitsha

Models of TB/HIV Care and Treatment

GH Friedland, MD12

Malawi model Anthony D Harries, HIV/AIDS Unit,

Ministry of Health, Malawi

• HIV program learns from and uses DOTS model• No true integration of TB and HIV care• Appropriate in Malawi

– Poor infrastructure with very few physicians – Large population with immediate need to start a

significant number of patients on ART• 1 million people infected with HIV• 170,000 people needing HAART

GH Friedland, MD13

Apply Tuberculosis Control structure to HIV treatment and care is one “model”

• Standardised diagnosis and case finding

(smear microscopy and well defined types of TB)

• Standardised treatment

(three treatment categories to cover all types of TB)

• Standardised recording and reporting system

(treatment cards, registers, cohort analysis, monitoring)

• Standardised system of drug procurement

• Management by paramedical officers

• Free drugs for patients

GH Friedland, MD14

Standardised Treatment Outcomes

TB Programme:• Cured • Treatment completed• Dead• Defaulted• Failed• Transferred out

ART delivery:• Alive and on ART• Dead• Defaulted• Stopped treatment• Transferred out

GH Friedland, MD15

TB programs serve as site for some integration and collaboration of services

The START study

• Demonstrate effectiveness and safety of HIV/TB integrated treatment strategy in an urban, resourced setting- Prince Zulu Communicable disease clinic, Durban, KwaZuluNatal, South Africa

• Partnership of:– I kithweni Muncipality Department of Health– CAPRISA- US NIH– Nelson R Mandela School of Medicine– Yale University, Columbia University– Irene Diamond Fund, Doris Duke Charitable Foundation

GH Friedland, MD16

START-PilotTB program staff strengthened

Patients with active TB offered HIV counseling & testing

ONCE-DAILY ART (DDI, 3TC, EFAVIRENZ) given concomitantly with standard TB DOT regimen (INH, RIF, ETH, PZA) 5 d/wk with weekend ART self administration

Adherence training and social support emphasized

Transition to ART self-administration at TB Rx completion-Referral to HIV Clinic

Assessment of viral load, CD4, mortality, side effects and toxicities

Assessment of acceptability and cost

GH Friedland, MD17

GH Friedland, MD18

Pilot START ResultsMean Viral load and CD4 change over 21 months

1

1 0

1 0 0

1 0 0 0

1 0 0 0 0

1 0 0 0 0 0

1 0 0 0 0 0 0

0 2 3 4 6 2 1

Me

an

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ad

(c

op

ies/

ml)

0

5 0

1 0 0

1 5 0

2 0 0

2 5 0

3 0 0

3 5 0

4 0 0

4 5 0

Me

an

Ab

solu

te C

D4

Co

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t (c

ell

s/u

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M e a n V ir a l L o a dM e a n C D 4 C o u n t

Self administration

GH Friedland, MD19

TB programs serve as site for some integration and collaboration of services

Sizonq’oba study

• Demonstrate effectiveness and safety of HIV/TB integrated

treatment strategy in a rural, resource-poor setting, Tugela

Ferry, KwaZuluNatal, South Africa

GH Friedland, MD20

The Sizonq’oba rural study

• Project outline: – Strengthening of TB DOT program– Merging TB DOT and Home Based Care Program – Training of physicians, nurses, community health workers-TB and HIV

– TB pts identified in hospital, receive VCT– Once-daily DOT ART added to Home-based /TB DOT program and given with

TB meds in community– Community and family social and adherence support– Community and clinical monitoring for benefit and risk. – Transition to self-administration at completion of TB therapy

– Cost effectiveness study– Sexual risk study

– Separate records, mostly separate staff, program monitoring, reporting, funding

GH Friedland, MD21

adherence support group

GH Friedland, MD22

Integrating 2 vertical services : HIV/AIDS and TB services , Khayelitsha, South Africa

David Coetzee, Eric Goemere

2000: opening HIV/AIDS clinics in public services, next to the TB clinic

2001: first HAART patient … > 1400 patients 9-05

2002: VCT re-enforced in TB service and easier access to HAART

2003: merging both buildings and stepwise integration of HIV and TB services

GH Friedland, MD23

Objectives of TB/HIV integration

• For TB patients• To stimulate VCT among TB clients

• 47 % counselled and 87 % accepted testing-(8-40 Gugulethu) 63 % co-infection

• To accelerate access to HAART for TB/HIV co-infected

• To reduce TB incidence among HIV patients

• To improve TB diagnostic algorithms

• To increase adherence and cure rate among TB patients by using the HIV adherence tools

• HIV 95% (36 mos vs TB ~75% Rx completion

• HIV adherence tools and counselors

GH Friedland, MD24

Objectives of TB/HIV integration

• For HIV patients

• To have an easier access to TB diagnosis and treatment

• To develop a one stop service

• To benefit from existing TB network to support HIV

• For the health services

• To pool TB and HIV staff and integrate training

• To improve staff morale

GH Friedland, MD25

develop a one stop service

• Both building have been merged • 2 different patient flows

– TB non co-infected :2 clinical visit/episode– HIV and co-infected :monthly clinical visit

• A positive impact on TB/HIV patients:– Reduced queuing time– Improved clinical monitoring– Allow adjustment for treatment interactions

• A negative impact on non-co-infected TB cases

GH Friedland, MD26

pool TB and HIV staff and integrate training

• Tb and HIV staff now able to rotate between services • No recruitment out of existing TB service but rather

re-enforcement • Improved staff morale with improved treatment

outcomes• New clinical career path for TB staff• Renewed doctor’s interest in TB

GH Friedland, MD27

Operational Issues in TB and HIV Care

• How to improve diagnosis of HIV in TB patients• Expand voluntary counseling and testing•Provide rapid point of care HIV testing• Provide routine counseling and testing in TB patients• Encourage provider based testing•Perform opt out vs. opt in testing

•How to improve diagnosis of TB and LTBI in HIV patients• Develop algorithms for clinical assessment of TB disease• Develop and use of rapid diagnostic tests

GH Friedland, MD28

Operational Issues in TB and HIV Care

• How to improve treatment of HIV in TB patients• Determine best setting(s) to initiate and continue antiretroviral

therapy in co-infected patients Degree of integration/collaboration

• Elucidate mechanisms to support adherence• Define the role of DOT in antiretroviral therapy

Identify most effective DOT dose, intensity and duration Determine most appropriate person(s) to provide

treatment• Determine role of non-physician health care workers• Determine role of community and family

• Determine training needs

• Determine how to minimize occupational/nosocomial risk from HIV and TB

GH Friedland, MD29

Operational Issues in TB and HIV Care

• How to improve treatment of HIV in TB patients

• Determine optimal time to start antiretroviral therapy

• Identify optimal antiretroviral regimens to use

• Determine how rifampin interactions with antiretroviral agent effect clinical outcomes

• Identify proper dose of antiretrovirals in the presence of rifampin

• Conduct observational and clinical trials to assess treatment effectiveness in co-infected patients

• Establish appropriate schedules for toxicity and efffectiveness monitoring

GH Friedland, MD30

Operational Issues in TB and HIV Care

•How to improve the treatment of TB in HIV patients• Determine ways to strengthen existing TB programs • Evaluate measures of treatment success• Examine role of newer diagnostic tests to assess treatment success.• Determine optimal duration of therapy

•How to accommodate differing TB and HIV traditions and practices