P50.04
Background: The MTN-008 trial, the first multi-dose study of a microbicide gel (2:1 randomized to tenofovir 1% or HEC placebo gel) during pregnancy, included daily pregnant participant gel insertion at home for 5 days. Because pregnancy may pose unique challenges to consistent gel use and acceptability these factors were assessed.
Methods: Participants completed a web-based computer-assisted self-interview (CASI) at Days 0 and 6 about gel attitudes and behaviors. At Day 6 trained research staff conducted a short interviewer-administered questionnaire with both structured and open-ended questions. Frequencies of quantitative data were tabulated in SAS; qualitative data were manually summarized.
Results: CASI data include 96 participants in both active and placebo gel arms. Self-reported adherence was high with 88% reporting daily gel use and the majority reporting no difficulty with daily use. The most common reason for nonuse was forgetting. Participants reported generally neutral perceptions of gel characteristics. Two-thirds thought the gel was runny, many complained of bothersome gel leakage and several cited this reason for not inserting a full dose. A small number of women (6–8%) reported pain, other physical discomfort, or mental discomfort associated with the process of applicator insertion, and fewer than 5% reported the same in regards to the gel itself. Although the majority were not worried the gel would cause problems for their pregnancy or babies, one-quarter to one-third felt somewhat worried about these issues. Ten percent of women said they would not use the gel in the future when not pregnant, while 38% would prefer to use gel only before sex and 32% had no preference between daily and pre-coital gel use.
Conclusions: Self-reported adherence to gel for 5 days at home was high. Gel was generally acceptable, but many complained of a runny consistency and leakage. There were no frequent or strong concerns about the effects of the gel on the pregnancy/ fetus reported.
