TOPICAL ESTROGEN TO THICKEN THE VAGINAL EPITHELIUM AND PREVENT INFECTIONS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goal of this research is to explore the use of topical estrogen in women as a means to thicken the vaginal epithelium and prevent HIV infection from vaginal intercourse. We also aim to show that application of topical estrogen can reverse the possible effects of depo medroxyprogesterone acepate (DMPA) on vaginal epithelium thereby making it possible to continue its widespread use as a contraceptive even if studies should show that, used without estrogen, it tends to increase the risk of HIV acquisition in high prevalence communities.. Simultaneously, we hope to show that the use of topical estrogen can prevent infection with a number of other sexually transmitted infections in both DMPA users and non-users. The major activities proposed to achieve the above objectives include: 1) a small clinical study on current DMPA users to evaluate whether use of a topical estrogen can thicken the vaginal epithelium, 2) a larger clinical study to evaluate whether thickening of the vaginal epithelium through application of topical estrogen can reduce the rate of STI (and, if possible HIV) infection among sexually active heterosexual women, 3) a qualitative component to assess acceptability of the topical estrogen among women and their partners, 4) (depending on the outcome of the above components), assisting with registration of the product for this indication and assisting with training and promotion of the use of topical estrogen as an adjunct to DMPA for prevention of STI (and HIV) infection among DMPA users and perhaps also women who do not use DMPA. Planning sessions were completed at a meeting Hormonal Contraception and HIV Transmission Sponsored by NIH. Applications for Funds to carry out the study have been requested from the International Partnership for Microbicides.