Abstract

Objectives: To evaluate the acceptability of COL-1492, a vaginal gel containing 52.5 mg nonoxynol-9, in an HIV prevention trial.

Methods: Sex workers participating in a phase II/III triple blind, randomised trial in Benin, Côte d’Ivoire, South Africa, and Thailand were interviewed on the gel’s acceptability at monthly scheduled clinic visits. Safer sex counselling, male condoms, and study gels were given at each monthly visit; a gynaecological examination and HIV test were performed. Phase III interviews considered the participants’ appreciation of the gel. On the first, second, and fifth follow up visits, the study volunteers completed more extensive questionnaires.

Results: Responses were similar between treatment arms. Women indicated not liking their gel in 1.8% of the visits; 98.1% of the women found the gel easy to apply; 30.1% said that it affected sexual intercourse. These effects were mostly improvements (92.6%) by facilitating intercourse (73.6%). Intercourse was more often affected in women reporting painful sexual intercourse (OR: 2.59 (95% CI 1.63 to 4.12)) and in older women. The latter effect differed among centres.

Conclusion: Most participants found their assigned gel acceptable and the vast majority of reported effects on intercourse were favourable. The type of gel had no significant impact on the findings.