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PROGRAM Preclinical Trial Research and Preparation For over a decade, the Population Council has taken a multidisciplinary approach to the search for an effective, female-initiated method of HIV/STI prevention. To prepare for both human testing and the eventual use of a microbicide product should one be successfully developed, Council researchers have articulated the need for a vaginal microbicide to AIDS experts, scientists, funding agencies, and other policymakers; engaged in education and dialogue with the communities where trials take place; and included the people who would use the product in its development.
In 1994 Council researchers began a collaboration with a group of women’s health advocates to incorporate women’s views and perspectives early in the product development process. This international group, the Women’s Health Advocates on Microbicides (WHAM), met regularly for several years, giving input to the Council’s early program development, reviewing study protocols, and helping to design a study on women’s preferences for formulations of existing over-the-counter spermicides, with important implications for developing microbicides. In 1997, Council staff and WHAM members convened an international symposium to address the ethical challenges involved in microbicide clinical testing (See "Ethics and Informed Consent," below) and wrote a widely distributed report on its findings.[1] Council researchers have also conducted acceptability research to assess potential microbicide users’ perspectives, because products will not be effective if they are unappealing. Such research has been carried out both in the context of clinical trials and in free-standing studies. Interviews conducted in clinical trials of Carraguard®, as well as in a study of the Microlax® applicator used to dispense Carraguard, have shown that both men and women generally find Carraguard acceptable and would recommend it to friends if it were available. In several qualitative studies about a hypothetical product, men and women expressed an interest in using a microbicide as well. A study conducted in South Africa found that providers, community members, and policymakers felt that microbicides have the potential to have a major impact on the HIV pandemic. Projects Publications/Resources on this topic 2004 See Also Contact: microbicide@popcouncil.org [1] Heise, Lori, C. Elizabeth McGrory, and Susan Y. Wood. 1998. “Practical and ethical dilemmas in the clinical testing of microbicides: A report on a symposium.” New York: International Women’s Health Coalition. (contact publications@popcouncil.org to request a hard copy of this publication)
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