Journal Article

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

Peda Melissa, Kramzer Lindsay, Devlin Bríd, Bauermeister, José A, Marzinke, Mark A, Hendrix, Craig W, Lucas, Jonathan, Macagna Nicole, Dunne, Eileen F, Dezzutti, Charlene S, Gundacker Holly, Cranston, Ross D, Ayudhya Ratiya Pamela Kunjara Na, Piper Jeanna, Singh, Devika, Nuttall, Jeremy, Hoesley Craig, Tingler, Ryan C, Johnson, Sherri, Jacobson, Cindy E, Dominguez, Clara, Brown, Elizabeth, Ho, Ken, McGowan, Ian

2022

Overview

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 = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 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.

• Publisher: Springer Nature B.V
• Subject: Acceptability / Adults / Biomedicine / Condoms / Diarrhea / Disease prevention / Drug delivery systems / Health behavior / HIV / Human immunodeficiency virus / Placebos / Prevention / Prevention programs / Preventive medicine / Rectum / Registration / Side effects