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Abstract ISSUES: Microbicide efficacy trials include data collection on sexual behavior and testing women for HIV, STIs, and pregnancy. Enrolled women are required to use the study product before each sex act. These aspects of trial screening and participation raise challenges for the study counselors providing counseling to the women. Ethically it is imperative that researchers provide trial participants with appropriate, high-quality counseling to facilitate trial adherence, to ensure proper understanding of test results and study participation, and to meet participants’ study needs during their trial participation. DESCRIPTION: A Phase 3 efficacy trial of Carraguard® is currently underway at three sites in South Africa: Gugulethu in Cape Town (University of Cape Town); Soshanguve, outside Pretoria (University of Limpopo); and Isipingo, south of Durban (Medical Research Council). A trial-specific counseling manual was developed, including procedures for voluntary HIV and STI testing, risk reduction, ongoing informed consent, and study product adherence. At each site, counselors meet regularly with investigators and mentors to address the issues that arise through the development of strategies and ongoing counselor development. The average age of women screened for the trial is 31, and that of their partners is 36. These women typically have low condom usage, (an average of 32% at last sex act reported at screening) with very high rates of STI infection (from 18% to 43% HIV prevalence across sites). A review of counseling meeting minutes and discussions with counselors has revealed that HIV, other STIs, negotiating condom use, understanding study procedures, and study product adherence are the most recurrent issues in counseling sessions. Through exploring the concerns and struggles that face microbicide trial participants, this paper will bring into to focus the importance of appropriate and responsive counseling procedures within microbicide trials. CONCLUSION: The appropriate and careful training and mentoring of counselors beyond just HIV pre- and post-test counseling is crucial to providing an ethical and relevant counseling service to microbicide trial participants. Holistic counseling contributes to recruitment and retention of participants in microbicide trials. Poster Session
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