"Tell Juliana": acceptability of the candidate microbicide VivaGel® and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study.

This study assessed acceptability of the candidate microbicide VivaGel(®) and two placebo gels among 61 sexually active young US and Puerto Rican women at three sites. Participants were randomly assigned to use one of the gels twice per day for 14 days. At trial completion, 59% of the women in the VivaGel(®) group reported being likely to use the gel in the future, whereas 23% were unlikely to use it and 18% were undecided. Participants reported problems with all three gels, including the "universal" placebo containing hydroxyethyl cellulose (HEC). The most frequent complaints were leakage, interference with sexual behavior, and decreased sexual satisfaction. Some of the complaints are not new but remain unresolved. Women's perceived risk of HIV infection may determine whether the gels are used. Users also may want a choice of viscosity. Poor acceptability of vaginal microbicide formulations may result in poor adherence to gel use during efficacy trials and compromise validity of results.

RCT Entities:   Population Interventions Outcomes