Acceptability of novel, microbicide BufferGel during a phase I safety trial in Thailand, India, Zimbabwe, and Malawi

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 (−5 ml) of BufferGel vaginally twice per day for 14 days. Acceptability was assessed through survey and daily diary data among women, and exit focuis group interviews with both women and men. Results Overall study compliance, procedures, and product use was high across sites. In Malawi and Zimbabwe, about one-third of women reported that it was difficult not to 'finger-cleanse' during the trial. Across all sites, 58% reported disliking the need to use condoms during sex, and men were particularly vocal about this. When the question, 'would you use BufferGel if it were approved?', 100% and 90% of women from Zimbabwe and 90% of women from Malawi reported affirmatively. In contrast, 62% of Thai women and 33% of Indian reported that they would definitely use BufferGel, while 37.5% and 34.3% reported that they 'might' use it if it were available. However, women in India did not feel at risk for using such a product, although they thought higher risk women would use it. When asked if BufferGel could be used without a partner's knowledge, the majority of women and men felt that it would not be possible because of the 'wetness' or 'messiness' of the product during and after sex. Conclusions Assessing acceptability and use of topical microbicides during a clinical trial provides valuable information for Phase II/III trials and future product development. Qualitative data from both men and women provide contextual and culture-specific information. Overall acceptability of BufferGel was high across sites, but highest among women in Zimbabwe and Malawai. This is no doubt related to cultural norms and a higher perception of risk among African women, compared to the other two sites.