Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026)
José A Bauermeister, Ryan C Tingler, Clara Dominguez, Eileen F Dunne, Craig Hoesley, Ken Ho, Sherri Johnson, Jonathan Lucas, Nicole Macagna, Elizabeth Brown, Holly Gundacker, Melissa Peda, Cindy E Jacobson, Lindsay Kramzer, Devika Singh, Charlene S Dezzutti, Ratiya Pamela Kunjara Na Ayudhya, Mark A Marzinke, Jeanna Piper, Bríd Devlin, Jeremy Nuttall, Ian McGowan, Craig W Hendrix, Ross D Cranston, MTN 026 team, José A Bauermeister, Ryan C Tingler, Clara Dominguez, Eileen F Dunne, Craig Hoesley, Ken Ho, Sherri Johnson, Jonathan Lucas, Nicole Macagna, Elizabeth Brown, Holly Gundacker, Melissa Peda, Cindy E Jacobson, Lindsay Kramzer, Devika Singh, Charlene S Dezzutti, Ratiya Pamela Kunjara Na Ayudhya, Mark A Marzinke, Jeanna Piper, Bríd Devlin, Jeremy Nuttall, Ian McGowan, Craig W Hendrix, Ross D Cranston, MTN 026 team
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 = 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.
Keywords: Dapivirine; HIV; HIV prevention; Microbicides; Rectal.
Conflict of interest statement
Conflict of interest The authors declare that there are no conflict of interest.
© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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Source: PubMed