Over 33 million people worldwide are estimated to be living with HIV in 2009, with almost 16 million of these being women. Most live in Sub-Saharan Africa where 60% of HIV infections are in women. Sub-Saharan Africa also has a high proportion of women using hormonal contraception, particularly the injectable progestin depot-medroxyprogesterone acetate (DMPA). While recent studies have documented the efficacy of antiretroviral pre-exposure prophylaxis (PrEP) in reducing risk of HIV acquisition, in the CAPRISA-004 study, HIV incidence remained high (5.6 per 100 woman-years) in the experimental group receiving tenofovir gel;most women in this study used DMPA. Determining whether hormonal contraception has an effect on HIV acquisition is a critical unanswered public health issue. We are requesting funding to support initial development of a multi- center, randomized trial to evaluate the impact of use of the copper IUD versus DMPA for prevention of HIV acquisition in women. Secondary aims of the future trial are to evaluate whether age or HSV-2 infection status modifies any effect of contraceptive use on HIV acquisition, and whether study arm has any impact on pregnancy and contraceptive continuation rates. The trial will be conducted at 2-3 clinical research sites in Southern Africa. We will randomize women using or wanting to use injectable contraception to DMPA every 3 months or copper IUDs. Participants will return for clinic visits including HIV testing every 3 months for a period of one year. This R4 planning grant will be used to support investigators'time, travel, and supplies to: a) establish te multidisciplinary protocol team;b) identify collaborators and clinical sites that can successfully recruit, enroll, and follow-up sufficient numbers of eligible participants, and conduct appropriate informed consent, clinical and data collection procedures, c) develop necessary study documents including the study protocol, the statistical and data management plans and the study manual of procedures, d) develop a detailed budget for the entire research study period including for appropriate sub-contracts, and e) work with collaborators to develop informed consent forms and training materials. Completion of these aims is expected to result in the development and submission of an R01 grant application. We anticipate that the time dedicated to the R34 planning period will enhance the efficiency and quality of the future trial. With an estimated 2.6 million new HIV infections worldwide in 2009, the need for simple, effective and inexpensive prevention approaches is critical. If IUDs can lower the risk of HIV acquisition in a population of women who would otherwise use injectable contraceptives, our results could make an important contribution to the Millennium Development Goal of halting and beginning to reverse the spread of HIV/AIDS by 2015.
We are requesting funding to support initial development of a multi-center, randomized trial to evaluate the impact of use of the copper IUD versus DMPA for prevention of HIV acquisition in women. Because HIV infection primarily affects women of reproductive age, determining whether hormonal contraception has an effect on HIV acquisition is a critical unanswered public health question. The proposed Clinical Trial Planning Grant will support important planning activities for the clinical trial including the identification of collaborators and clinical sites, development of necessary study documents including the study protocol and manual of procedures and creation of a detailed budget for the trial.
