Background The HIV epidemic is driven by social, cultural and economic gender inequalities that limit women's ability to protect themselves from infection. A critical need in stemming the spread of the HIV/AIDS pandemic is to expand the range of methods that women can use for the prevention of all sexually transmitted infections, including vaginal microbicides. A microbicide- a product used vaginally to prevent infection - would offer the potential for women to protect themselves from HIV and other sexually transmitted infections (STIs). To be truly female-controlled, the ideal microbicide would be effective, safe, acceptable, affordable, colourless, odourless, tasteless, easy to store and use, and available in a variety of preparations. It should also be available in contraceptive and non-contraceptive formulations and obtainable without a prescription. However, because the first microbicide to be developed is unlikely to be an "ideal" product with all these characteristics, the immediate priority is to develop a microbicide that provides protection if used consistently by those who need it most. In terms of the benefit of the microbicide in protecting male partners from STIs, no previous studies have addressed this issue, however, researchers in this field believe that a woman's male partner would also be protected from infection if she used a vaginal microbicide. Microbicides have been shown to be effective against many sexually transmitted pathogens in vitro and they appear to be most effective in vivo as prophylaxis against cervical infection by N. gonorrhoeae, C. trachomatis and vaginal infection by T. vaginalis. Despite the established need for a female-controlled barrier method, many scientists, pharmaceutical companies and investors remain skeptical about the feasibility of achieving this goal. In part, this uncertainty derives from the lack of conclusive scientific data demonstrating that, as a class, female-controlled barrier methods have the potential to reduce the transmission of STIs. Without results from well-controlled clinical trials that test the efficacy of these methods, their potential role in an overall program of HIV prevention will remain subject to debate. A US based non-profit research organisation, with a strongly feminist agenda, is planning a Phase II study of a microbicide in an African country. Laboratory tests show that the product blocks HIV attachment to target cells in vitro and in animals. In Phase I testing in five countries, the product caused no significant signs of irritation and women generally found it acceptable and easy to use. The proposed Phase II trial is a randomized, double blind trial designed to further assess the safety and effectiveness of this product. It will be conducted with co-investigators from a medical university in the host country. The project sites are two family planning clinics in two locations, which have been renovated for the study in order for the laboratory facilities to be upgraded and for more nursing and support staff to be employed. Recruitment and site selection Approximately 300 women will use the gel or placebo for one year by applying it vaginally at least three times weekly as well as before intercourse. To participate in this trial, women must be 18 years or older, HIV-negative when they enroll and they must reside in the community for at least one year prior to study, with no intention of leaving for another year. Individual informed consent will be obtained from each participant by one of the researchers with the aid of a translator if necessary. Consent will not be sought from male partners. After enrolling in the trial, women will come to the clinic monthly to be examined for signs of irritation and tested for sexually transmitted infections; every three months they will be tested for HIV and asked a series of product acceptability questions. At these visits the women will receive free condoms and counselling, both for safer sex and to ensure that they understand the trial requirements and objectives. Prior to being tested for HIV and receiving their results if they choose, (women have the option not to get their results) they will engage in pre- and post-test counselling. If a woman is found to have a treatable STI she will receive treatment; if she is found to have HIV or another condition she will be referred to health and support services (secondary/tertiary hospitals or social workers) available in the local area. There will be no contact tracing, though those found to have an STI (including HIV) will be encouraged to bring in their partner for testing. Women diagnosed as HIV-positive can continue to participate in the trial if they choose, so that leaving the trial does not signify HIV serostatus. All participants will receive modest monetary compensation for time and transport for each visit as well as refreshments.
Questions for discussion: 1. Since men would be exposed to the experimental product during intercourse, should investigators seek their informed consent? 2. If a woman becomes HIV positive during the trial, should her regular partner be informed? What if she has more than one partner?
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