Acceptability of a Carrageenan-Based Candidate Vaginal Microbicide and Matching Placebo: Findings from a Phase II Safety Trial among Women in Chiang Rai, Thailand

Abstract Objective: To evaluate extended acceptability of vaginal use of a carrageenan-based candidate microbicide and placebo in northern Thai women. Methods: As part of a randomized, placebo-controlled, triple-blinded clinical trial, women were asked to insert gel with each vaginal sex act and at least three times per week for 1 year. Used applicators were collected monthly; acceptability questions were asked quarterly. Results: One hundred sixty-five women were enrolled (83 microbicide, 82 placebo); 148 (90%) remained in the study for 12 months. Gel use was high, with ≥87% returning at least three used applicators per week at each visit. Although acceptability was generally high, some decline in positive reporting was noted in terms of ease of application, timing of gel insertion, and gel volume over time. Approximately one quarter reported gel use increased her sexual pleasure. Over one quarter reported that gel volume of 5 mL was too much. All women with a steady partner at 12 months reported talking...