Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026)

Abstract

This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants’ acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N\u2009=\u200926; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n\u2009=\u200914; 53.8%) or more (n\u2009=\u200911; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n\u2009=\u200913; 50%) or that they liked condoms and the gel equally (n\u2009=\u20098; 30.8%). Side effects across products included leakage (n\u2009=\u20098; 30.8%), diarrhea (n\u2009=\u20094; 15.4%), or soiling (n\u2009=\u20091; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention. Trial Registration: NCT03239483.