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02676_2 ACCEPTABILITY OF CARRAGUARD AMONG HETEROSEXUAL COUPLES IN A SIX-MONTH CLINICAL TRIAL IN THAILAND Blanchard, Kelly1 In phase II trials Carraguard use has been shown to be safe and acceptable in women. To evaluate safety and acceptability among heterosexual couples, we conducted a six-month, randomized, triple-blinded trial of Carraguard (3% carrageenan) compared to 2.5% methyl cellulose placebo in Chiang Rai, Thailand. We enrolled 55 low-risk couples who were in good health, were monogamous, did not use condoms regularly, and were free of HIV or other sexually transmitted infections (STIs). Couples were randomized to Carraguard or placebo gel and were asked to use the gel each time they had vaginal sex. The couples came for monthly follow-up visits including genital/pelvic exams, STI testing, interview and counseling. Follow up and adherence with gel use instructions were >90% at each scheduled visit. There were no significant differences in acceptability between the two study arms, and acceptability remained high for the duration of the study. At study close, 85% of men and 92% of women reported they liked the gel somewhat or very much; 73% of men and 67% of women reported increased sexual pleasure; and 63% of men and 56% of women reported increased sexual frequency during the study. None of the men thought the gels had caused them any symptoms; 44% thought women could use the gel without her partner noticing it, and 94% thought that any increase in lubrication during sex was an advantage. Carraguard use was acceptable to low-risk heterosexual couples in northern Thailand. Kelly Blanchard |
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