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

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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.

Resumen

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.

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Acknowledgements

The study team gratefully acknowledges the study participants of MTN-026 and the International Partnership for Microbicides (IPM) and the Microbicide Trials Network (MTN) for providing the study product. We are also grateful to the local research teams for their work. In the Thailand site, we recognize the work of Dr. Pachara Sirivongrangson, Dr. Suparat Khemnark, Dr. Suthat Chottanapund, Dr. Chaiwat Ungsedhapand, Dr. Anupong Chitwarakorn, Dr. Wasin Matsee, Dr. Andrew Hickey, Dr. Boonyos Raengsakulrach, Wannee Chonwattana, Kusuma Auethavornanan, Jaray Tongtoyai, Pikunchai Luechai, Patsaraporn Khongsom, Anchalee Warapornmongkholkul, Warunee Thienkrua, Chariya Utenpitak, Wichuda Sukwicha, Pitthaya Disprayoon, Somsak Yafant, Rinda Wongbenchaporn, Jirawat Suksamosorn, Nichnawee Kamchaithep, and Navakan Navanuch. We also recognize the contributions by the Pittsburgh site team, including Carol Mitchell, Dani Camp, and Stacey Edick, and the Alabama site team, including Faye Heard, Shay Warren, Megan Tilley, and Kadie Fry.

Funding

The study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the official positions of the U.S. Centers for Disease Control and Prevention.

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Authors and Affiliations

  1. University of Pennsylvania, 418 Curie Blvd, Room 222L, Philadelphia, PA, 19104, USA

    José A. Bauermeister & Ryan C. Tingler

  2. Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Clara Dominguez, Elizabeth Brown, Holly Gundacker & Melissa Peda

  3. ivision of HIV/AIDS Prevention, D, Centers for Disease Control and Prevention, Atlanta, GA, USA

    Eileen F. Dunne

  4. Thailand Ministry of Public Health-US CDC Collaboration, Bangkok, Thailand

    Eileen F. Dunne

  5. University of Alabama at Birmingham, Birmingham, AL, USA

    Craig Hoesley

  6. Microbicide Trials Network, Pittsburgh, PA, USA

    Cindy E. Jacobson, Lindsay Kramzer, Devika Singh, Charlene S. Dezzutti, Ratiya Pamela Kunjara Na Ayudhya & Craig W. Hendrix

  7. FHI 360, Durham, NC, USA

    Sherri Johnson, Jonathan Lucas & Nicole Macagna

  8. University of Pittsburgh, Pittsburgh, PA, USA

    Ken Ho, Charlene S. Dezzutti & Ian McGowan

  9. Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Mark A. Marzinke & Craig W. Hendrix

  10. Division of AIDS/NIAID/NIH, Bethesda, MD, USA

    Jeanna Piper

  11. International Partnership for Microbicides, Silver Spring, MD, USA

    Bríd Devlin & Jeremy Nuttall

  12. University of Barcelona, Barcelona, Spain

    Ross D. Cranston

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  1. José A. Bauermeister
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the MTN 026 team

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Correspondence to José A. Bauermeister.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Bauermeister, J.A., Tingler, R.C., Dominguez, C. et al. Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Behav 26, 1333–1346 (2022). https://doi.org/10.1007/s10461-021-03490-8

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