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

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.