U.S. Department of Defense PEPFAR ART Program September 25, 2006 Presented by Tiffany Hamm, Ph.D. U.S. Military HIV Research Program Walter Reed Army Institute for Research

DoD PEPFAR Country Programs Treatment Services for Military and Civilian Personnel in Africa: Funding and Implementation Sources Funding/ Implementation Blue: DoD only Red: Combined DoD and other agency/partner Yellow: Other agency/partner only

DoD: A “Dual” Program Functions as an agency and an implementer. DoD HIV/AIDS Prevention Program (DHAPP) 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 FY07 ($62.7M): 62.4% support mil-mil programs (many reaching civ. populations) 37.6% for mil-civ efforts (~$23.5M COP FY07) 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.

USMHRP Treatment 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

Kenya DoD Treatment Sites ART TB/HIV PMTCT

Nigeria DoD Treatment Sites

Tanzania DoD Treatment Sites

Uganda DoD Treatment Sites

Progress In Care and Treatment as of March 2007 Total Number of Patients (number of facilities) 56%61% 60%57%60%66%57% (21) (8) (23) (4) %: percent female

Cumulative Achievements in Care and Treatment Total Number of Patients 52% * ***** Programs initiated and began reporting: * Tanzania, ** Uganda, *** Nigeria (6) (25) (10) (20) (42) (56) 48% 60% 59% (number of facilities) %: percent female

Current Pediatric ART as of March 2007 Number of Children (0-14 yrs.) (number of facilities) (21) (4) (23) (8)

USMHRP’s First Pediatric ART Patient

Cumulative Achievements in Pediatric ART Number of Children (0-14 yrs.) (6) (10) (20) (25) (42) (56) ****** Programs initiated and began reporting: * Tanzania, ** Uganda, *** Nigeria (number of facilities)

PMTCT Services Number of Pregnant Women (number of facilities) *** (41) (49) (59) (74) (108) (192) Programs initiated and began reporting: * Tanzania, ** Nigeria

TB/HIV Services Number of Patients (number of facilities) (1) (2) (3) (7) (16) (28) *** Programs initiated and began reporting: * Nigeria, ** Tanzania

DoD USMHRP ART Program Start Date: Kenya, Apr. 2004; Tanzania, Jan Programs built upon capacity initiated through HIV research activities Sites: Kericho District Hospital (Kenya), Mbeya Referral Hospital (Tanzania) Immediate catchment population: 2.5 million and 1 million Sample: Patients on treatment longer than 18 months (adults and peds.) Data: Unlinked data from patient files

Clinical Outcomes Baseline CD4 CD4 at 6 months CD4 at 12 months CD4 at 18 months Median Median Difference from Baseline Median CD4 Counts* Proportion of patients alive after 6 and 12 months of ART: 1,888 out of 2,117 (89%)** Proportion of patients, who started ART, remained on ART for 1 or more years: 1,518 out of 1,714 (88%)** Proportion of patients, who have been on ART for at least 1 year, are still on the original ARV regimen: 820 out of 1,488 (55%)** * Kenya and Tanzania, ** Kenya only

Percent patients on 1st and 2nd Line Proportion of patients on 1st and 2nd line regimens: Switch to second line determined through clinical and symptomatic assessments (WHO staging), declining CD4 (after 6 months on ART >30% drop), and review of patient adherence (pill count, self reports). Viral loads (VL) done in Kenya, Tanzania and Uganda to inform decision to switch to second line. Cut off <400-1,000 copies/ml. VL capacity planned for Nigeria in Cross-sectional study in Kenya in late 2006 (n=172, not controlled for time on treatment) showed 12% of patients had detectable VL (>400). Currently planning PHE comparing “older” monitoring vs. VL+ every three months. Across sites, planning cross-sectional VL study of patients on treatment longer than 6 months to determine viral suppression among patient populations. 95.5% 0.5%

Prevention and Clinical Services DoD programs started with a focus on behavior prevention, VCT and PMTCT. Introduction of ART led to an increase in demand for CT upon which prevention messages and efforts were strengthened. Integration of PMTCT with HIV treatment services. Inclusion of peer education programs as an aspect of clinical care in military settings. Participate actively in USG roll out of prevention for positives (both OGAC TWG and country team levels) with risk reduction counseling is an integral part of ART adherence counseling. Linkage of hospital services to community resources for adherence and HBC among community groups surrounding health facilities to reinforce prevention/prevention for positives messages.

Sustainable Approach 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. Build upon existing systems and functional mechanisms/roles/bodies. Develop ongoing training capacity as part of the partner portfolio. Strengthen logistic infrastructure and capacity of military counterparts in areas of reagent and pharmaceutical supplies. Barriers Reliant on USG and local logistics in many cases for civ. programs. Long term solutions to HR recruitment/retention and infrastructure support.

Impact of Activities Trained over 2,200 individuals in ART and 1,300 in palliative care. Improved HIV clinic, CT, ANC, lab, TB clinic and delivery ward infrastructure. Integrated HIV treatment and prevention into general medical education in the realms of internal medicine, pediatrics and ob/gyn. Improved lab and pharmacy services and capacity in stock management and forecasting. Enhanced patient data collection and usage. Stronger linkages between/among community programs and clinical services: Kenya: LWHC, Samoei, Kericho Youth Center Nigeria: Barracks HIV/AIDS Committees, local NGOs Tanzania: Networking of NGOs, women’s barracks groups Uganda: CAI, Kayunga Youth Center

The Way Forward Expand services to lower level facilities and address HR/task shifting. Continue to transition technical capacity to partners and move towards more of a management role. Improve local partners capacity to evaluate their own services focusing on improving quality. 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.

n=600 CLADE: Clinic-based ART & Diagnostic Evaluation: A Public Health Evaluation of Routine vs. Viral Load Guided ART in Rural Kenya 1:1 Routine Care VL Guided Care Primary Endpoint: Viral Failure (defined by VL>50 copies/ml By HIV-1 reverse transcriptase PCR reaction (Amplicor HIV-1 Monitor Test, v1.5, Roche Diagnostic)) Eligibility: > 18 y/o CD4 < 200, or TB/HIV with CD4 <350 No prior ART 12 mo Secondary Endpoints: 1.Death 2.Hospitalization 3.OIs 4.WHO Stage 5.Adherence 6.Lost-to-follow-up 7.Proportion in agreement between CD4+WHO vs. “blinded” VL in “Routine Care” arm 9.Proportion 2 nd Line 10.Viral resistance 11.Adverse events 12.Disease Progression Baseline: Clinical exam Routine Labs WHO staging CD4, Viral Load (VL) Resistance testing Routine Care: Via “older” Kenya MOH Guidelines F/u q6mo with CD4s+WHO Staging or prn VL prn Viral Load Guided Care: Via “newer” Kenya MOH Guidelines F/u q3mo with VL, CD4, WHO Staging or prn Use of algorithm guided care for 2 nd line switch D. Shaffer Sep 23, 2007 Co-Primary Endpoint: Viral Failure, Disease Progression, or Death

Clinical Outcomes Continued: Kenya Proportion of patients still on the same regimen after 1 year of treatment: Regimen Number of PatientsProportion of Patients InitiatedStill Active D4T30 3TC NVP % D4T30 3TC EFV % D4T40 3TC NVP % D4T40 3TC EFV % D4TSYR 3TC EFV % AZT 3TC EFV/NVP 10880%