Linkage to HIV Care and Treatment via Clinical Research--the USMHRP

Approach

COL Nelson Michael, M.D., Ph.D.Walter Reed Army Institute of Research

U.S.Military HIV Research Program

20 June 2008

Global Campaign for Microbicides

Outline

• HIV and the military

• Background and approach

• Worldwide network

• Research studies

• Care and treatment

HIV - A Worldwide Threat

• HIV disproportionately affects the most productive age strata of society in the developing world.

• This leads to destruction of individuals, families, communities and political institutions.

• The impact of HIV/AIDS adds to burdens of poverty, disease, and conflict to erode regional stability.

• HIV/AIDS is a threat to deployed US military, peacekeepers, and aid workers.

HIV Threatens World Security

Ongoing United Nations Peacemaking MissionsUNAMSIL1999-

MINURSO1991-

UNMIBH1995-

UNMOP1996-

UNFIL1978-

UNIKOM1991-

UNMISET2002-

UNMIK1999-

UNOMIG1993-

UNMOGIP1949-

UNTSO1948-

UNMEE1974-

UNFICYP1964-

MONUC1999-

UNDOF2000-

HIV Adult prevalence rate

15.0% - 39.05%

5.0% - 15.0%

1.0% - 5.0%

0.5% - 1.0%

0.1% - .05%

0.0% - .01%

Not available

Goals:

• Defuse regional conflicts• Prevent enemies from using WMD• Support global economic growth• Reduce the toll of HIV/AIDS and

other infectious diseases• Transform the US military for the

21st century

HIV/AIDS is a US National Security Threat

• In 1986, USMHRP was initiated as a result of US Congressional directive

• Mission:

Develop a GLOBALLY effective HIV-1 vaccine

Targeted HIV-1 genotype and epidemiologic surveillance to guide vaccine development

Evaluation and implementation of disease prevention modalities through clinical research at the Military Treatment Facilities

USMHRP support of the President’s Emergency Plan for AIDS Relief

Background and Mission

USMHRP

Walter Reed Army Institute of Research

• State of the art vaccine research and development facility in Rockville, MD

• Five international vaccine development sites

• Twenty international surveillance sites

• Seven military medical center treatment facilities (MTFs)

USMHRP Worldwide Network

Philosophy of USMHRP

integrate prevention and care and treatment into all research program activities

• A credible prevention program must accompany any vaccine research study

• HIV care for vaccine participants is an international standard

• General standards of medical care must be adequate to: provide parity compared to HIV care distinguish product related adverse events from disease

• In resource poor settings, medical benefits (including care for HIV+) should be available to the community to avoid coercive inducement to volunteer

• Development of local capacity to execute and manage programs/services is critical to ensure sustainability

Integrating Research and Prevention, Care and Treatment

Research

CommunityFamily

Health CarePreventionTreatment

• Maintain a low level of US technical staff

• 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.

• Develop ongoing training capacity as part of the partner portfolio.

• Strengthen logistic infrastructure and capacity of counterparts.

Sustainable Approach

• 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 an.

• 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

Impact

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 activities

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

Program

Treatment and Care Laboratory Infrastructure

As of March 31st, 2008

Capacity Developed

Current 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

Tota

l Num

ber o

f C

lient

s

HISIS - HIV prevalence & incidence

HISIS No. of seroconverter

Person years Incidence absolute Incidence

95% CI lowIncidence 95% CI up

Retention rate

Overall Incidence

40 641 6.24 4.4 8.1

Year one 24 170 14.10 8.9 19.3 89.5%

Year two 7 163 4.29 1.2 7.4 84.8%

Year three 3 150 2.00 0.2 4.2 80.0%

Year four 6 158 3.80 0.8 6.8 74.5%

• 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.

The Way Forward

Summary

• USMHRP is dedicated to the development of a globally effective HIV vaccine relying on discovery, NHP, and clinical trials.

• USMHRP executes clinical research in seamless integration with prevention, care, and treatment programs.

• USMHRP works in multilateral partnership with global HIV prevention and care stakeholders.