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02463_2 ACCEPTABILITY OF CARRAGUARD® AMONG HIV-INFECTED WOMEN AND MEN IN A SAFETY TRIAL IN SOUTH AFRICA Braunstein, Sarah* Introduction: Microbicides may offer HIV-infected women and men protection against sexually transmitted infections, and may protect their partners from HIV and other infections. It is therefore important to understand acceptability of potential microbicides among this population. Methods: We assessed acceptability during a Phase I safety study of Carraguard, the Population Councils lead candidate microbicide, among 20 healthy HIV-positive sexually abstinent women and men, and 20 HIV-positive sexually active women in Durban, South Africa. Participants were randomized to use Carraguard, placebo (methyl cellulose), or condoms only. Women inserted gel vaginally every evening for 14 days, and men applied gel to the penis every evening for 7 days. Acceptability data were collected in interviewer-administered questionnaires and in-depth interviews. Results: Preliminary, blinded, quantitative findings for 20 sexually abstinent women and 20 men are included here; results for sexually active women and qualitative findings will be included in the final presentation. Gel application did not cause any pain or irritation in men. Fifteen percent of women (2 out of 13) reported pain or irritation during some gel insertions, and 8% (1 out of 13) after some gel insertions. Men and women gave the same overall ratings for the study product: 62% liked it very much, 30% liked it somewhat, and 8% were neutral. Few men (23%) and women (15%) disliked the amount of gel they had to apply/insert. Few women and men (between 0 and 8%) disliked the gels color, smell, or packaging. Most women (63%) reported that they prefer sex to be somewhat lubricated, but 62% of women (8 out of 13) and 54% of men (7 out of 13) felt the gel was sometimes, often or always too wet. About half (54%) of men and 39% of women felt the gel could be used without their partners knowledge. All participants said they would buy the gel to use with their spouse/steady partner if available as a microbicide, and 69% of women (11 out of 16) and 63% of men (12 out of 19) said they would prefer to use a microbicide alone over condoms alone or both. Conclusion: The study gels were generally acceptable to the HIV-positive sexually abstinent women and men in this study. Sarah Braunstein |
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