OBJECTIVES: The objectives of this study were to determine what volume of a microbicide placebo gel is acceptable when applied intrarectally before receptive anal intercourse (RAI); and to evaluate responses to properties of the gel, its application, and its use. STUDY DESIGN:HIV-uninfected men who reported unprotected RAI with serodiscordant or unknown-status partners were enrolled in a volume escalation trial. RESULTS: Up to 35 mL of gel with the physical properties of Femglide (transparent and odorless) was acceptable to the majority of participants. Choice of different levels of viscosity may be needed. For some men, volumes judged acceptable when tried without intercourse were not acceptable when used during sex. Overall, participants reported high intentions to use microbicides when available. Condom use was inconsistent despite advice to use condoms. CONCLUSIONS: Microbicides that would require up to 35 mL of volume to be effective would be acceptable to men who engage in high-risk RAI.
RCT Entities:
OBJECTIVES: The objectives of this study were to determine what volume of a microbicide placebo gel is acceptable when applied intrarectally before receptive anal intercourse (RAI); and to evaluate responses to properties of the gel, its application, and its use. STUDY DESIGN:HIV-uninfectedmen who reported unprotected RAI with serodiscordant or unknown-status partners were enrolled in a volume escalation trial. RESULTS: Up to 35 mL of gel with the physical properties of Femglide (transparent and odorless) was acceptable to the majority of participants. Choice of different levels of viscosity may be needed. For some men, volumes judged acceptable when tried without intercourse were not acceptable when used during sex. Overall, participants reported high intentions to use microbicides when available. Condom use was inconsistent despite advice to use condoms. CONCLUSIONS: Microbicides that would require up to 35 mL of volume to be effective would be acceptable to men who engage in high-risk RAI.
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