U.S. Department of DefensePEPFAR 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/partnerYellow: 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

0

5,000

10,000

15,000

20,000

25,000

Kenya Nigeria Tanzania Uganda

Enrolled in Care

Ever on ART

To

tal

Nu

mb

er o

f P

atie

nts

(number of facilities)

56% 61%61% 60%57%60% 66% 57%

(21)

(8)

(23)

(4)

%: percent female

Cumulative Achievements in Care and Treatment

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

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

Enrolled in Care

Ever on ART

To

tal

Nu

mb

er o

f P

atie

nts

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

0

100

200

300

400

500

600

700

800

900

Kenya Nigeria Tanzania Uganda

Female

Male

Nu

mb

er o

f C

hil

dre

n (

0-14

yr

s.)

(number of facilities)(21)

(4)

(23)

(8)

USMHRP’s First Pediatric ART Patient

Cumulative Achievements in Pediatric ART

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

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

Female

Male

Nu

mb

er o

f C

hil

dre

n (

0-14

yr

s.)

(6)(10)

(20)

(25)

(42)

(56)

* ** ***

Programs initiated and began reporting: * Tanzania, ** Uganda, *** Nigeria

(number of facilities)

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

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

Tested for HIV

Received NVP

PMTCT ServicesN

um

ber

of

Pre

gn

ant

Wo

men

(number of facilities)

* **

(41) (49)(59)

(74)

(108)

(192)

Programs initiated and began reporting: * Tanzania, ** Nigeria

0

500

1,000

1,500

2,000

2,500

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

Female

Male

TB/HIV ServicesN

um

ber

of

Pat

ien

ts (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. 2005

• 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 148 242 302 358

Median Difference from Baseline

118 154 179

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:

1st line2nd line

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 2008.

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

RoutineCare

VL GuidedCare

Primary Endpoint:

Viral Failure

(defined by VL>50 copies/mlBy HIV-1 reverse transcriptasePCR 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. Death2. Hospitalization3. OIs4. WHO Stage5. Adherence6. Lost-to-follow-up7. Proportion in agreement between

CD4+WHO vs.“blinded” VL in“Routine Care” arm

9. Proportion 2nd Line10. Viral resistance11. Adverse events12. 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 2nd line switch D. Shaffer

Sep 23, 2007

Co-Primary Endpoint:

Viral Failure, DiseaseProgression, or Death

Clinical Outcomes Continued: Kenya

Proportion of patients still on the same regimen after 1 year of treatment:

Regimen

Number of Patients Proportion of Patients

Initiated Still Active

D4T30 3TC NVP 511 306 60%

D4T30 3TC EFV 542 309 57%

D4T40 3TC NVP 164 93 57%

D4T40 3TC EFV 124 91 73%

D4TSYR 3TC EFV 137 13 9%

AZT 3TC EFV/NVP 10 8 80%