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.