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Abstract BACKGROUND: The real-world use-effectiveness of a microbicide will depend on both its clinical efficacy and on women’s and couples’ willingness to consistently use the product. Women may need messages and strategies other than disease protection in order to negotiate microbicide use with their partners. We present responses from couples participating in a safety trial of the candidate microbicide Carraguard® that may point to such strategies. METHODS: We enrolled 55 HIV-negative, low-risk couples who were monogamous and not regular condom users in a triple-blind, placebo-controlled trial with product use for six months. Acceptability data were collected through structured questionnaires and open-ended questions asked at intervals from the two-week visit through to closing; GEE logistic regression was used to test for trend in responses over time. At the six-month closing study visit, couples were also asked about hypothetical product characteristics they would find important in a vaginal microbicide. RESULTS: Overall acceptability was high with 92% of women and 83% of men reporting that they liked the gel somewhat or very much. Among women at the two-week visit, 56% reported that gel use resulted in increased sexual pleasure, and 46% reported that it resulted in increased frequency of sexual intercourse; by the closing visit these figures rose to 67% (p=0.04) and 57% (p=0.05), respectively. Among men, 54% reported increased sexual pleasure at the two-week visit, rising to 72% at closing (p<0.01); and 41% reported increased frequency of intercourse, rising to 63% at closing (p<0.01). When asked about hypothetical product characteristics, most women (60%) and men (81%) considered extra lubrication “very important.” Characteristics considered “very important” by significantly more men than women included making the vagina tight (91% of men vs. 43% of women, p<0.0001), slowing the time to ejaculation (72% of men vs. 23% of women, p<0.0001), and a good smell (77% of men vs. 32% of women, p=0.0001). DISCUSSION: The high proportion (increasing with duration of use) of both men and women reporting that gel use improved the pleasure and frequency of sex suggests that future marketing of microbicides using a combined message of pleasure and protection may be feasible. The importance that men, in particular, placed on gel attributes related to sexual pleasure should be considered in both the formulation and the social marketing of microbicide products. Track D: Pathways to Access a Successful Microbicide: Advocacy, Policy, and Mobilization
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