Barcelona 2013
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| Abstract #304 - E-Posters English | ||||
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Session: 50.113: E-Posters English (Poster) on Sunday in Chaired by Authors: Presenting Author: Dr. Cynthia Woodsong - International Partnership for Microbicides, United States |
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| Additional Authors: Dr. Jordi Casabona, Sra Cristina Sanclemente, Dra. Anna Esteve, Dra. Victoria Gonzalez, Grupo HIVITS TS, | ||||
| Aim: Three large-scale trials of vaginal microbicides for HIV prevention, one testing a vaginal gel and two testing a vaginal ring, are currently in the field, with results expected in 2014-2015. If results of any of these trials are positive, the product/s must be made available as quickly as possible. Social and behavioral science data provides important information about for microbicide introduction. Key issues include users? understanding of how microbicides work and how they are meant to be used. This paper will summarize what has been learned in microbicide trials about comprehension of use instructions and use requirements, partial efficacy (when compared to correct and consistent condom use), and direction of effect (who is protected. Examples will be presented from multiple clinical trials, with a focus on two microbicide gel trials, and two trials of vaginal rings, conducted in sub-Saharan Africa. | ||||
| Method / Issue: The two gel trials were randomized placebo controlled trials with a study design that differed only in the active gel formulation being tested. Trial participants applied a vaginal gel containing an anti-retroviral daily for six weeks. A total of 380 women participated in the trials, and in addition to acceptability and adherence data provided during product use, data were collected in focus groups with 162 trial participants and individual interviews with 55 male partners of participants at the end of the study. The first vagina ring study was a randomized trial of the safety and acceptability of a placebo ring worn for 12 weeks, with a new ring provided every four weeks. 170 women participated in this trial, and as above, at the end of the trial, focus groups and individual interviews were conducted with 48 women and 19 male partners, respectively. The second vaginal ring trial was a placebo-controlled trial testing safety and acceptability of a vaginal ring containing an anti-retroviral. 280 women wore a vaginal ring for 12 weeks, with a new ring provided every four weeks. | ||||
| Results / Comments: Building on the experiences and data collected in previous trials, these trials adapted counseling on vaginal gel or ring use, explicitly addressing common misunderstandings, fears, concerns, and challenges that were identified by trial participants. Additionally, locally-appropriate illustrated materials for product use instructions were developed (examples will be shown). The materials, and the counseling and instructions that accompany them, provide a foundation for development of materials needed for future product introduction programs. The microbicide trials have also revealed a number of misperceptions that women and their partners have about the nature and type of product efficacy that microbicides may provide. | ||||
| Discussion: After two decades of clinical trials it is still an open question whether a topical vaginal product containing ?microbicides? can prevent sexually transmitted HIV infection. However, effective introduction efforts must anticipate how clinical trial experiences will translate to a non-trial environment. Although specific counseling about product efficacy cannot be delivered until efficacy is demonstrated, lessons learned from previous trial experiences form a framework for the types of information that will be required. | ||||
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