DoD/PEPFAR ART Program

COL Nelson Michael, M.D., Ph.D.

Walter Reed Army Institute of ResearchU.S. Military HIV Research Program

Track 1.0 ART Program Meeting: Willard Intercontinental Track 1.0 ART Program Meeting: Willard Intercontinental HotelWashington, D.C.Washington, D.C.

August 11-12, 2008

DoD: A “Dual” Program

• Functions as an agency and an implementer.

• DoD HIV/AIDS Prevention Program (DHAPP), also seriving as the PEPFAR Executive Agent for DoD, and the U.S. Military HIV Research Program (USMHRP).

• DHAPP mil-mil: USMHRP mil-mil & mil-civ.

• Direct DoD PEPFAR funding in focus countries for COP FY08 ($83.3M) based on current MOA (May 2008):

• 50.2% support mil-mil programs (many reaching civ. populations)

• 49.8% for mil-civ efforts (~$41.5M COP FY08)

• Programs cover the full spectrum of PEPFAR program areas (country dependent).

• DoD provides direct TA to sites via clinical, lab and prevention experts.

• Level of in-country staffing for direct support/management varies.

DoD HIV/AIDS Programs in Africa (FY08)

Funding Sources

Red: PEPFAR Focus Country

Blue: PEPFAR Mini-Cop/Bilateral Country

Grey: DHAPP

White: No DoD Funding

USMHRP

Note: Sudan is a PEPFAR Mini-Cop country and DoD serves on PEPFAR Core Team but there is no DoD funding or presence in country.

• Maintain a low level of ex-pat/DoD technical staff with a focus on local resources for service delivery.

• Empower local leadership in determining course and approach to expansion.

• Expand clinic staff based on capacity of partner to absorb positions into annual budgets.

• Ongoing training capacity as part of the partner portfolio.

• Strengthen logistic infrastructure and capacity of local counterparts in areas of reagent and pharmaceutical supplies.

Sustainable Approach

USMHRP PEPFAR Programs

• Kenya

South Rift Valley: 2.5 million people

Kenya Department of Defense: 100K military + dependents

• Nigeria:

Nigerian Ministry of Defense: 380K active and retired military + dependents and ~1.5 million civilians

• Tanzania:

Southern Highlands: 6 million people

Tanzania Peoples Defense Forces: 120K military + dependents and ~800K civilians

• Uganda:

Kayunga District: 300K+ people

Catchment populations

Objectives of ART Activities

• Develop the local capacity to provide quality care and treatment services for HIV positive individuals, including necessary laboratory support.

• Enhance community networks through indigenous partners by linking treatment services with prevention and care.

• Increase the local capacity to support HIV treatment services by improving the technical knowledge and skills of indigenous staff and partners.

Continuum of Care in Resource Poor Settings

OVCOVC

Clinical Care &Support

Clinical Care &Support

Counseling and Testing

Counseling and Testing

PMTCTPMTCT

PreventionABC/IEC

PreventionABC/IEC

TransmissionPrevention

TransmissionPrevention

Home BasedPalliative

Care

Home BasedPalliative

Care

MTCTPlus

MTCTPlus

ARTART

Kenya DoD PEPFAR Sites

ART

TB/HIV

PMTCT

Nigeria DoD PEPFAR Sites

Tanzania DoD PEPFAR Sites

Uganda USMHRP* PEPFAR Sites

* DHAPP supports Uganda Peoples Defence Forces in country not depicted here or in ART and Care data on following slides.

Patients Currently on ART by Country (>41K)*

0

5,000

10,000

15,000

20,000

25,000

30,000

Mar. 05 Sep. 05 Mar. 06 Sep.06 Mar.07 Sep. 07 Mar. 08

KenyaNigeriaTanzaniaUganda

To

tal

Nu

mb

er o

f P

atie

nts

* As of March 31st, 2008.

Percent pediatric cases as of March 31st, 2008 ranges from 4.4% in military programs (TPDF) to 10.2% civilian programs (SRV).

Patients Receiving Facility Based Clinical Care by Country*

0

50,000

100,000

150,000

200,000

250,000

300,000

Sep. 04 Mar. 05 Sep. 05 Mar. 06 Sep.06 Mar.07 Sep. 07 Mar. 08

Kenya

Nigeria

Tanzania

Uganda

To

tal

Nu

mb

er o

f P

atie

nts

* As of March 31st, 2008.

Clinical Outcomes

Median CD4 Counts*

Baseline CD4

CD4 at

6 months

CD4 at

12 months

CD4 at

18 months

CD4 at

24 months

Median 136 246 316 376 398

Median Difference from Baseline

- 110 180 240 262

Proportion of patients alive after 6, 12 and 24 months of ART: 1,992 out of 2,259 (88%)

Proportion of patients, who started ART, remained on ART for 1 or more years: 2,115 out of 2,580 (82%)

• Kericho District Hospital (Kenya). Cohorts of patients on treatment for period specified above (adults and peds.).• Data: Unlinked data from patient files, n = 2,190.

As of March 31st, 2008

Capacity Developed

Program

Number of palliative care outlets

Number of staff trained in provision of HIV palliative care

Number of ART outlets

Number of staff trained in provision of ART

Number of laboratories with capacity to perform 1) HIV tests and 2) CD4 tests and/or lymphocyte tests

Number of individuals trained in the provision of laboratory-related activites

Kenya 388 810 131 835 11 12Nigeria 37 172 41 208 34 86Tanzania 162 792 111 1,673 60 186Uganda 30 227 17 164 10 41Total 617 2,001 300 2,880 115 325

Treatment and Care Laboratory Infrastructure

Treatment of Common Opportunistic Infections

Infection Diagnosis Treatment Med. Supply*

Pulmonary TB Sputum/X-ray/AFB smear plus CXR - varies by country

MOH based Usually available

Cryptococcocal Meningitis CrAg** Fluconazole Erratic

Pneumocystis Carinii pneumonia Clinical symptoms CTX Adequate

Bacterial Pneumonia Clinical symptoms Antibiotics Adequate

Cutaneous fungal infections Clinical symptoms Antifungal creams and tablets

Erratic

Muco-cutaneous candidiasis Clinical symptoms Antifungal creams and tablets

Erratic

Diarrhea diseases Clinical symptoms Supportive therapy Adequate

HSV Clinical Symptoms Acyclovir Out of stock in Tanzania

Toxoplasmosis Clinical Symptoms High dose CTX Adequate

* Similar availability across countries, though some variation.** Kenya and Tanzania.

Cotrimoxazole Preventive Therapy

CTX provision varies by country and in accordance with local MOH guidance.

• Kenya HIV infected adults, adolescents and children are started on CTX after HIV diagnosis. Remain on CTX regardless of

ARV, treatment, clinical or immunological status.

HIV exposed infants are started on CTX from the age of 4-6 weeks and are only discontinued when an HIV negative status is confirmed.

Rate of uptake for qualified patients registered in the program is 90%. 10% of patients are allergic to sulphur base drugs.

• Nigeria All HIV positive, not just ART eligible initiated on CTX.

Drug availability- the drug cannot be imported and SCMS cannot purchase locally (certification issue). The Country will soon be issuing the drugs to our sites through the National Program.

• Tanzania All eligible patients for ART (CD4<200) get CTX prophylaxis.

Approximately 90% of eligible patients are provided with CTX.

• Uganda CTX given to all HIV+ patients (Dapsone given to those sensitive to CTX).

DoD procures over 80% of the CTX as govt. stock outs are common.

Malaria Prevention

• Kenya Malaria is the 2nd highest cause of morbidity (14 - 20% of out patient visits). Education on malaria prevention done at every military unit, Medical Reserve Station, ANC and ART clinics (military

and public). All military troops are provided with insect side treated mosquito nets. Pregnant women in malaria zones are provided with Intermittent Preventive Treatment using Sulphadoxine

Pyimethamine (PMI and other sources).

• Nigeria Limited to bed-nets and no presence of PMI in country.

• Tanzania Patients on ART are provided with antimalarial treatment in the CTC and provided health education on malaria

prevention.

Bed nets are provided to both children and pregnant women through ANC and CTC (linkage with PMI).

• Uganda All HIV+ patients receive malaria education at HIV clinic.

All HIV+ patients receive insecticide treated bed nets and early diagnosis and/or treatment for malaria as part of basic preventive care package (distribution between 95-100% of all patients via trained treatment club members - PLH).

Newly diagnosed HIV+ mothers receive preventive treatment.

Current and Future Directions

• Expanding services to lower level facilities and addressing HR/task shifting.

• Continue to transition technical capacity to partners and move towards more of a management role.

• Improve Early Infant Diagnosis (EID) and microbiology diagnostic capabilities.

• Continue to develop local partners capacity to evaluate their own services focusing on improving quality.

• Take more advantage and expand upon PHE opportunities and research experience to work with partners to:

Evaluate best methods of service delivery and how to expand. Address aspects of long term treatment and treatment failure.

Integrated Care, Treatment and Research

WHO

The Emergency Plan

The Global Fund

The World Bank

HIV Care and Treatment

HIV Research

DoD/HHS/NIH/CDC

Global HIV Vaccine Enterprise

IAVI/HVTN

WHO/UNAIDS

ANRS/MRC/EU/EC

Private Industry

Academia

Provides a comprehensive community-based platform to

support ethical research

Informs best practices and practical solutions in resource limited

settings for care and treatment

Enhancing ART ProgramsPublic Health Evaluation Initiatives

Current PHE activities or those to be submitted:

• Kenya

FY07 CLADE Study FY08 PMTCT, Pending FY09 Care and Treatment, Pending

• Tanzania

FY08 Early Mortality, Pending Pre-ART, Pending

• Uganda

FY08 Early Mortality, Pending PMTCT, Pending Facility Based AIDS Care, Pending

CLADE: Clinic-based ART & Diagnostic Evaluation A Public Health Evaluation of Routine vs. Viral Load Guided ART in ART Clinics in Rural Kenya

1:1

RoutineCare

VL GuidedCare

Primary Endpoints:1. Viral Failure2. Cost-Effectiveness

Eligibility:• > 18 y/o • CD4 < 200, or • TB/HIV with CD4 <350• No prior ART• Identified by clinic staff as eligible to begin ART

18 mo Ministry of Health follow-up

Secondary Endpoints:1. Combined clinical

outcome (AIDSprogression asdefined by 2 new WHO III or 1 newWHO IV event)

2. Death3. Hospitalization4. OIs5. Adherence6. Lost-to-follow-up7. Viral resistance in

treatment failuresand all viral failuresat the final study visit

8. Feasibility of VLmonitoring

9. Costs of VL monitoring10. GCP adherence

Baseline:• Clinical exam• Routine Labs• WHO staging• CD4, Arm-B Viral Load (VL)• Resistance testing (population based, random n=200)

Routine Care:• F/u q6mo with CD4s+WHO Staging or prnViral Load Guided Care:• F/u q6mo with VL, CD4, WHO Staging or prn

n=840

6-12 mo enrollment

24-30 mo study follow-up per participant (~ 1900 pt-years)

Primary Analyses:1. Chi Square/Fishers Exact tests and hazards analyses for VL endpoint2. Cost-effectiveness based upon viral success and variable costs 3. Routine descriptive statistics based upon metrics of feasibility, GCP, and comparative secondary endpoints

As of July 29, 2008