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Clinical Trial
. 2022 May;26(5):1333-1346.
doi: 10.1007/s10461-021-03490-8. Epub 2021 Oct 17.

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

José A Bauermeister  1 , Ryan C Tingler  2 , Clara Dominguez  3 , Eileen F Dunne  4   5 , Craig Hoesley  6 , Ken Ho  7 , Sherri Johnson  8 , Jonathan Lucas  8 , Nicole Macagna  8 , Elizabeth Brown  3 , Holly Gundacker  3 , Melissa Peda  3 , Cindy E Jacobson  9 , Lindsay Kramzer  9 , Devika Singh  9 , Charlene S Dezzutti  9   7 , Ratiya Pamela Kunjara Na Ayudhya  9 , Mark A Marzinke  10 , Jeanna Piper  11 , Bríd Devlin  12 , Jeremy Nuttall  12 , Ian McGowan  7 , Craig W Hendrix  9   10 , Ross D Cranston  13 ; MTN 026 team
Affiliations
Clinical Trial

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

José A Bauermeister et al. AIDS Behav. 2022 May.

Abstract
in English, Spanish

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.

Este estudio describe la aceptabilidad de un microbicida rectal (RM) con dapivirina (DPV) formulado como un gel por hombres y mujeres de dos países (Estados Unidos y Tailandia) que participaron como parte del Microbicide Trials Network (MTN)-026. Evaluamos la aceptabilidad de un gel rectal de DPV y un placebo como parte de un estudio de Fase I (N = 26; 18 hombres, 8 mujeres). Los participants informaron una aceptabilidad favorable sobre el gel del estudio; la mayoría de los participantes informaron que les gustó el gel igual (n = 14; 53.8%) o más (n = 11; 42.4%) que cuando comenzaron el estudio. Más de la mitad de los participantes señalaron que preferirían el gel sobre los condones (n = 13; 50%) o que les gustaban los condones y el gel por igual (n = 8; 30,8%). Los efectos de los productos incluyeron fugas (n = 8; 30,8%), diarrea (n = 4; 15,4%) o ensuciamiento (n = 1; 3,8%). La alta aceptabilidad de un gel rectal enfatiza su promesa para la prevención biomédica de acción corta y justifica futuras investigaciones para la prevención del VIH.

Keywords: Dapivirine; HIV; HIV prevention; Microbicides; Rectal.

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Conflict of interest statement

Conflict of interest The authors declare that there are no conflict of interest.

Figures

Fig. 1
Fig. 1
Study visit schedule
See this image and copyright information in PMC

References

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