Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team

Abstract

Background and objectives: Incomplete condom use during anal sex persists among gay men; microbicides may provide additional protection. Despite the absence of efficacy or safety data, many gay men use sexual lubricants containing nonoxynol-9 (N-9), a detergent-based spermicide under evaluation for efficacy as a vaginal microbicide.

Goal: Evaluate unprotected sex, lubricant use, and attitudes regarding possible participation in clinical trials of rectal microbicides among high-risk human immunodeficiency virus-(HIV) seronegative U.S. gay men in six cities.

Study design: A total of 3,257 gay men were interviewed and responded to a self-administered questionnaire at enrollment into a longitudinal cohort study of HIV seroincidence.

Results: Among 2,216 men who practiced receptive anal intercourse in the previous 6 months, 438 (20%) reported they never used condoms. More than three fourths of 3,093 men who had anal sex used lubricants more than 80% of the time. 41% of whom actively sought N-9 containing products. About two thirds said they were definitely or probably willing to participate in rectal microbicide clinical trials.

Conclusion: Condom use is imperfect among men who report anal sex. N-9 lubricants are popular. Most gay men in this cohort indicate willingness to participate in rectal microbicide studies.