1. 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

2. Outline HIV and the military Background and approach Worldwide network Research studies Care and treatment

3. 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.

4. HIV Threatens World Security

5. 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 21 st century HIV/AIDS is a US National Security Threat

6. 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

7. 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)

8. USMHRP Worldwide Network

9. 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

10. Integrating Research and Prevention, Care and Treatment Research Community Family Health Care Prevention Treatment

11. 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

12. 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

13. As of March 31st, 2008 Capacity Developed

14. Current ART by Country (>41K) Total Number of Clients

15. HISIS - HIV prevalence & incidence HISISNo. of seroconverter Person yearsIncidence absolute Incidence 95% CI low Incidence 95% CI up Retention rate Overall Incidence 406416.244.48.1 Year one2417014.108.919.389.5% Year two71634.291.27.484.8% Year three31502.000.24.280.0% Year four61583.800.86.874.5%

16. 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

17. 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.