CDC’s Role in

PEPFAR Strategic Information and

Public Health Evaluation

Institute of Medicine

January 7, 2010

William C. Levine, MD, MSc

Global AIDS Program

CDC, Atlanta

2

Overview

Country-level and headquarters approaches toward

strategic information and PHE implementation

Examples:

PMTCT in Botswana

ART Track 1.0 and ART costing

I-RARE in South Africa

Kenya AIDS Indicator Survey

CDC Global AIDS Program (GAP) priorities and

contributions in support of PEPFAR

What is the problem?

● Situation Analysis and Surveillance

What are the contributing factors?

● Determinants Research

What interventions and resources are needed?

● Needs, Resource, Response Analysis & Input Monitoring

What interventions can work (efficacy & effectiveness)?

Special studies, Operations res., Formative res. & Research synthesis

Are we implementing the program as planned?

● Outputs Monitoring

What are we doing?

● Process Monitoring & Evaluation, Quality Assessments

Are interventions working/making a difference?

● Outcome Evaluation Studies

Are collective efforts being implemented on a large enough scale to impact the epidemic (coverage; impact)? ● Surveys & Surveillance

Understanding

Potential

Responses

Monitoring &

Evaluating

National

Programs

Determining

Collective

Effectiveness

ACTIVITIES

OUTPUTS

INPUTS

OUTCOMES

OUTCOMES

& IMPACTS

MONITORING

Problem

Identification

A Public Health Questions Approach

to Unifying Strategic Information

Are we

doing

the

right

things?

Are we

doing them

right?

Are we doing

them on a large

enough scale?

Case Study:

Routine HIV Testing in

Botswana

Background 1999: Botswana started Africa’s 1st free national PMTCT program

Voluntary counseling and testing during pregnancy 6 weeks of AZT for mothers; 4 wks for infants Free infant formula

Since late 2002, PMTCT services available in all public ANC clinics at no cost BUT

Poor uptake: Only 49% of pregnant women tested for HIV in 2002

Dec. 2003: Botswana president declared HIV testing to be performed routinely for those with medical need

2003 survey indicated knowledge of PMTCT facts predicted HIV test acceptance suggesting that pre-test education had great potential for impact

2004 pilot in 4 large public antenatal clinics used new pre-test education system and “opt-out” testing

HIV testing in antenatal care using voluntary vs. routine

testing strategies – Francistown, Botswana 2003-2004

(all differences p<0.05)

0

10

20

30

40

50

60

70

80

90

100

Voluntary Routine

Perc

en

t o

f p

reg

nan

t w

om

en

Tested

Returned after test

Given results

Percent of all HIV-positive pregnant women

receiving antiretrovirals during pregnancy, Botswana National PMTCT Program, 2002-2005

0

20

40

60

80

100

2002 2003 2004 2005

Perc

en

t o

f all

HIV

-po

sit

ive w

om

en

AZT

NVP

ARV therapy

Routine testing

began

National Impact

In late 2004 “routine” HIV testing was implemented nationally by the PMTCT program with CDC-Botswana assistance Routine testing a key reason Probably highest uptake in Africa

Successful Francistown protocol used as template for national implementation

Data used in development of generic PMTCT training curriculum

Broader Impact

International recognition and broad dissemination

Findings published in MMWR

Data used in development of generic PMTCT training curriculum

Influenced other country policies and programs

CDC Technical Protocols Supporting

PMTCT Program Development in

Botswana

• HIV antenatal sentinel surveillance (1999-2005)

• Survey of midwives and antenatal and postnatal women about PMTCT

(2003)

• Demonstration project on routine approach to HIV testing during

antenatal care (2004)

• Pilot of follow up for HIV-exposed infants using DNA PCR (2004)

• Field testing of PMTCT testing and counseling support tools for resource-

constrained settings (2005)

• Evaluation of adherence to short course ARV prophylaxis for PMTCT in

Botswana (2005)

• HIV incidence among pregnant and post-partum women (2007)

What is the problem?

● Situation Analysis and Surveillance

What are the contributing factors?

● Determinants Research

What interventions and resources are needed?

● Needs, Resource, Response Analysis & Input Monitoring

What interventions can work (efficacy & effectiveness)?

Special studies, Operations res., Formative res. & Research synthesis

Are we implementing the program as planned?

● Outputs Monitoring

What are we doing?

● Process Monitoring & Evaluation, Quality Assessments

Are interventions working/making a difference?

● Outcome Evaluation Studies

Are collective efforts being implemented on a large enough scale to impact the epidemic (coverage; impact)? ● Surveys & Surveillance

Understanding

Potential

Responses

Monitoring &

Evaluating

National

Programs

Determining

Collective

Effectiveness

ACTIVITIES

OUTPUTS

INPUTS

OUTCOMES

OUTCOMES

& IMPACTS

MONITORING

Problem

Identification

A Public Health Questions Approach

to Unifying Strategic Information

Are we

doing

the

right

things?

Are we

doing them

right?

Are we doing

them on a large

enough scale?

TRACK 1.0 ART Programs

Monitoring and Evaluating

National ProgramsActivities, Outputs, Outcomes

Track 1.0 ART Program

The Track 1.0 ART Program funded and administered by

CDC and Health Resources and Services Administration

(HRSA)

Four partners received Track 1.0 ART awards

AIDSRelief (Catholic Relief Services Consortium)

Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)

Harvard School of Public Health (Harvard)

Mailman School of Public Health of Columbia University

(Columbia)

Track 1.0 ART Quarterly

Reports Track 1.0 ART partners send standard quarterly data reports to CDC

and HRSA

Data reports sent via email in a spreadsheet or data file, accompanied by technical notes and description of achievements and challenges during the quarter

Reports must be approved by USG country teams prior to transmission to HQ

Data summarized at HQ and used for program monitoring by project officers at CDC and HRSA

Results, trends, and discrepancies reviewed and discussed with partners

Number of Persons on ART by Partner

and Quarter, as of September 30, 2009

0

250,000

500,000

750,000

1,000,000

1,250,000

FY04

Q4

FY05

Q1

FY05

Q2

FY05

Q3

FY05

Q4

FY06

Q1

FY06

Q2

FY06

Q3

FY06

Q4

FY07

Q1

FY07

Q2

FY07

Q3

FY07

Q4

FY08

Q1

FY08

Q2

FY08

Q3

FY08

Q4

FY09

Q1

FY09

Q2

FY09

Q3

FY09

Q4

Ever Started Current Started in Quarter

Program Totals

69% on ART

47,720 patients/quarter

1,002,122 Ever Started

On ART

EGPAF Project HEART:Percentage of Patients Ever Started on ART

Who Were Currently on ART, as of March 31, 2009

146

198

165 161

137 136124

115106

280

313 314

284 288

264 263256

227

318

353345 342 345

316

287 291279

0

50

100

150

200

250

300

350

400

Overall Rwanda Mozambique Nigeria Tanzania Lesotho Ethiopia South Africa Kenya

Baseline 6-Month 12-Month

Increases in median CD4+ cell counts

among cohorts of patients initiating ART

CD

4 C

ell

Co

un

t (c

ells

/ul)

n = 5,712 n = 10,581n = 22,936n = 9,162 n = 7,628 n =7,153N = 97,163

111

n = 7,759n = 26,178

Change in CD4 Count during 48 Months on ART Harvard MDH Program in Tanzania*

Months on ART*Shaded area = 95% CI

(n=13,575)

83.3 81.8 83.8

9.9 9.8 8.1

6.9 8.4 8.1

0%

50%

100%

6 months 12 months 18 months

Undetectable/< 40 cp/ML 40 - 500 cp/ML > 500 cp/ML

N=335 N=285 N=222

Proportion of patient with suppressed HIV RNAin Rwanda national program sample

% o

f p

atients

On Treatment, Viral Suppressionin Randomly Selected Patients, 2006 - 2008

88% 92% 87% 89%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2006 2007 2008 Combined

Year 2006 2007 2008 Combined

Total No. Sampled 863 2140 3161 6164

No. of Countries 3 5 3 6

PEPFAR Track 1.0 Implementing Partner

Site Evaluations

Conducted biannually by a member of the GAP Adult Care and Treatment Team

A variety of CDC Track 1.0 partner sites visited for evaluation of infrastructure, staffing, services offered, quality

Sites evaluated in the following areas: HIV/AIDS care and treatment (adult and pediatric) PMTCT Laboratory services Pharmacy

Site-specific and country implementing partner reports submitted to PEPFAR and in-country teams

Follow-up of major problems to ensure that they are addressed

HIV/AIDS Care and Treatment Program Evaluations

by PEPFAR Adult Treatment Technical Workgroup

Countries Evaluated since January 2007

Côte d’Ivoire

Guyana

Haiti (2007 and 2009)

Lesotho

Malawi

Mozambique

Namibia

Nigeria

Rwanda

South Africa

Swaziland

Tanzania

Uganda

Vietnam

Zambia

Zimbabwe

HIV/AIDS Care and Treatment Program Evaluations

by PEPFAR Adult Treatment Technical Workgroup

Haiti – 2009 Follow-up of Selected 2007

Recommendations 2007 recommendations fully implemented

Provide cotrimoxazole for all HIV-infected persons

Provide a “basic care package” nationally

Report selected PMTCT indicators quarterly

2007 recommendations in process of being

implemented

Train nurse practitioners to provide ART

Establish a National AIDS Council

Evaluate antiretroviral drug supply management

Standardize national early infant diagnosis

PEPFAR ART Costing

Project

Understanding Potential ResponsesInputs: Needs & Resource Analysis

PEPFAR ART Costing Project

Background

Centrally and country funded Public Health Evaluation study

63 Sites in seven countries (Nigeria, Ethiopia, Uganda,

Botswana, Vietnam, Mozambique, Tanzania)

Collaboration between CDC, USAID and PEPFAR country

program

Objectives

Estimate the annual per-patient cost of out-patient HIV

treatment

Inform PEPFAR planning and resource requirements for

treatment scale-up

Identify factors that drive costs

Create cost projection models for use at country and OGAC

levels

Key Products

Country reports

Five country reports disseminated or

currently in clearance

Two country reports in draft form

ART Cost Projection Models developed and

utilized at global and country levels

Intent to place country-level model into

public domain

Global Uses of PEPFAR Costing

Project Data and Model

First-generation costing model based on these data informed scale-up and resource-needs projections for the 2008 PEPFAR reauthorization legislation

Evolving model and growing dataset utilized to inform global planning and resource needs for ART budget requests in FYs 2009-2011

Use of PHE Costing Data for ART Program

Planning in Mozambique

During review of the 2009 Mozambique PEPFAR Country Operational Plan (COP), concerns raised that scale-up plans and allocated resources not aligned

Rapid cost-projection technical assistance provided from CDC Utilized just-available data from Costing PHE

country study and country-level model Enabled USG country team to project resource

needs given scale-up plans Informed modest modifications to COP and its

approval

Per-Patient Costs (PEPFAR, Direct)

over 5 years, Mozambique

$130$105

Future Directions and Priorities for

Costing and Modeling Efforts

Increased demands for accurate estimation of

resource requirements to justify budget requests

Costing activities being extended to all program

areas

Additional models in development

New prevention services model

Care model

Revised HCW model

Extension of ART Cost Projection Model to

incorporate VCT, PMTCT on front-end

Patient-level disease progression model

International Rapid Assessment

Response and Evaluation (I-RARE)

Understanding Potential ResponsesDeterminants and Formative Research

(I-RARE): Drug use and sexual risk among non-injecting

and injecting drug users in Cape Town, Pretoria and

Durban, South Africa

Objective: To assess patterns of drug use and sexual risk that increase vulnerability to HIV in South Africa

Methods: Qualitative assessment including observation, mapping, key informant interviews, focus groups and HIV testing

Study Population: Drug using commercial sex workers and MSM, injection drug and non-injection drugs users, service providers

Sample Size: 240 drug users and 20 service providers in each of three cities

I-RARE South Africa

Key Findings

High prevalence of overlapping drug & sexual risk behaviors

Mixing of vulnerable populations of drug-using CSWs, MSM, IDUs and NIDUs

High prevalence of HIV in drug-using study population (28%)

Barriers to accessing and utilizing risk reduction, substance abuse and HIV services

I-RARE South Africa

Policy and Programmatic Initiatives

Multi-sectoral consortia linking drug abuse treatment and HIV service delivery organizations developed in each participating city

Capacity developed among organizations working with the target populations to address HIV prevention and drug use Targeted outreach to drug users and drug-using sub-

populations (drug using sex workers and MSM)

Implementation of VCT in select drug treatment sites

Use of mobile VCT services for drug-using MSM

Kenya AIDS Indicator

Survey

Problem Identification /

Outcomes & Impact MonitoringSurveys & Surveillance

History of Surveillance

in Kenya

Antenatal sentinel surveillance 1990-2008

STI patient sentinel surveillance 1990-2008

Demographic and Health Surveys 1989, 1993, 1998, 2003 (with sero-component)

AIDS Indicator Survey 2007 First Kenya AIDS Indicator Survey Data collection: mid-August to mid-

December, 2007

Methods

Nationally representative household

survey of persons aged 15-64

Informed consent for interview,

blood draw, storage

Included testing for HIV, CD4, HSV-

2, and syphilis

Test results returned to patients

KAIS: CD4 Distribution among

HIV-infected adults not on ARV therapy

CD4 Cell Count

Category (cells/μl)Percent % Estimated Number

<250 18.1 214,000

250-349 12.1 144,000

350+ 69.8 825,000

Total 100.0 1,183,000

Coverage of Antiretroviral (ARV) Therapy among

Eligible HIV-infected Participants

KAIS: Key Recommendations

Scale-up supply and delivery of care & treatment to meet needs of newly-diagnosed persons

Emphasize prevention with positives Partner HIV testing Consistent condom use STI screening and treatment Family planning Supportive disclosure Cotrimoxazole for all and ARV for those eligible

CDC’s Priorities and

Contributions in Support of

PEPFAR

42

CDC’s Global Health Strategy

Work in partnership to: Assist Ministries of Health to plan, effectively manage, and evaluate

health programs

Achieve goals adopted by USG programs and international

organizations to improve health, including disease eradication and

elimination targets

Expand CDC’s global health programs that focus on the leading causes

of mortality, morbidity and disability, especially chronic disease and

injuries

Generate and apply new knowledge to achieve health goals

Strengthen health systems and their impact

OGHA

HHS

OGAC

State Department

CDC

Office of the Director

Global AIDS Program

Center for Global Health

GAP Management Relationships

44

What are CDC GAP’s key activities?

CDC GAP’s contributions that leverage CDC’s core strengths Implementation and transition to MoH and local implementing

partners for care, treatment, prevention Health systems strengthening Integrated lab capacity building Surveillance implementation, training and translation Human capacity development, focusing on public sector for

sustainability Data-driven program decision-making (both at HQ and in the field)

Consistent with the PEPFAR reauthorization legislation, CDC GAP providing leadership in: Program monitoring Impact evaluation research and analysis Operational research Cost effectiveness and impact analysis Training and retaining 140,000 health care paraprofessionals

45

HIV Care and

Treatment

Branch

International

Laboratory

Branch

Management and

Operations Office

Science

Office

Country

Management

Office

Policy and

Communication

Office

Office of

the

Director

43 Country Offices

(supporting an additional 37 countries through headquarters and regional offices)

HIV

Prevention

Branch

International

Program

Development

Branch

Epidemiology

and Strategic

Information

Branch

November 2009

Maternal and

Child Health

Branch

Program

Budget and

Extramural

Mgmt Branch

Health

Economics,

Systems, and

Integration

Branch

Proposed Organizational Chart

CDC/CGH/Division of Global HIV/AIDS (Program) – [GAP]

Global AIDS Program

Priorities for PEPFAR II

Increase host-country government capacity for

leading and managing HIV/AIDS programs

Strengthen surveillance, monitoring and evaluation,

and health information systems in support of

HIV/AIDS program development

Increase evidence-based HIV/AIDS prevention

programs

Expand quality HIV/AIDS care and treatment services

and transition these services to local ownership