Bentley M, Fullem A, Srirak N, Jogelkar N, Khumalo-Sakutukwa G, Mwafulirwa L, Celentano D, Kelly C, Rosenberg Z, Nelson K; International Conference on AIDS.

Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPpC1170.

A. Fullem, Massachusetts HIV/AIDS Surveillance, Boston, Massachusetts, United States

Background: The aim of this study was to evaluate, during a Phase I safety trial, the acceptability and use of BufferGel, a topical microbicide that buffers vaginal pH in the presence of semen. Methods: Literate, HIV/STD negative, sexually abstinent and sexually active women in 4 international sites (Thailand, India, Zimbabwe, and Malawi)inserted one applicator (~5ml) of BufferGel vaginally twice per day for 14 days. Acceptability was assessed through survey and daily diary data among women, and exit focus groups interviews with both women and men. Results: Overall study compliance, procedures, and product use was high across sites. In Malawai and Zimbabwe, women were less likely to comply with the study rule not to finger-cleanse/douche their vagina during the trial. Use of condoms during the trial was reported as difficult by 11-47% of sexually active women. BufferGel was considered "wet/drippy" or "sticky" by about one-third of women in India, but this was infrequently reported in the other sites. Women in the two African sites were unanimous that they would use BufferGel if it were safe and available, women in Thailand only somewhat less willing, but 83% of abstinent and 40% of sexually active women in India were "completely unwilling" to use Buffer-Gel if it were available. Conclusions: Assessing acceptability and use of topical microbicides during a clinical trial provides valuate information for Phase II/III trials and future product development. Qualitative data from both men and women provide contextual and culture-specific information. Overall acceptabilty of BufferGel was high across the sites, except in India. This may be related to cultural norms and/or a lower perception of risk of STDs/HIV among Indian women, compared to women in the other sites.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Anti-Infective Agents
• Anti-Infective Agents, Local
• BufferGel
• Clinical Trials as Topic
• Clinical Trials, Phase I as Topic
• Coitus
• Female
• Gels
• HIV Infections
• Humans
• India
• Malawi
• Male
• Safety
• Sexually Transmitted Diseases
• Spermatocidal Agents
• Thailand
• Vagina
• Zimbabwe

Other ID:

• GWAIDS0001753

UI: 102239246

From Meeting Abstracts