The University of Alabama at Birmingham proposes to coordinate a three-site HPTU in Lusaka, Zambia, Port- au-Prince, Haiti, and in Birmingham. The emphasis of the proposal is to find cost-effective strategies for HIV prevention emphasizing mother to child transmission, barrier/microbicide research, STD control, and linked behavior change work. Specific research concepts are presented in this proposal. UAB is joined by collaborators from four US schools of medicine/public health (Cornell, Harvard, Miami, Vanderbilt); the oldest HIV/AIDS non-governmental agency in Haiti (GHESKIO); and multiple governmental and non-governmental entities in Zambia including the District Health Board (responsible for the large network of Lusaka primary care clinics), the University Teaching Hospital, the Virology Laboratory, and the University of Zambia School of Medicine. Expatriate staff working on all trials abroad will do so under the field policy direction of the on-site study directors, Drs. Moses Sinkala and Chewe Luo in Zambia, Jean Pape in Haiti. Existing cohorts suitable for immediate research consideration include: pregnant women in Lusaka clinics, discordant couples in both Lusaka and Port-au-Prince, low- and high-risk women in barrier method studies in Birmingham, and persons with tuberculosis and STDs in Port-au-Prince. The Birmingham site will extend our existing studies of inner city women enrolled in studies of female condoms and microbicides, perhaps the largest such active cohort in the US. A collaboration with the AVEU/HVTU at UAB (M. Mulligan, Principal Investigator) and Vanderbilt (P. Wright, Principal Investigator) for Zambia and Haiti collaboration respectively, ensures maximum potential for pediatric vaccine trials. The Principal Investigator (S. Vermund) of this collaborative HPTU presentation is on both the Executive Committee and the Prevention Leadership Group of the HPTN, facilitating maximum communication and coordination. Management structures, ethics review committees and processes, community advisory boards, and scientific oversight Committees are in place. Support from national and local officials in Zambia and Haiti is documented. The application describes field scientific and logistical experience that suggests the three sites will continue to function at a high level, even in impoverished settings that do present specific challenges. Since other research and service funding supports these cohorts, the costs to maintain them prior to trials beginning are minimal.
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