Literature DB >> 34657218

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

José A Bauermeister1, Ryan C Tingler2, Clara Dominguez3, Eileen F Dunne4,5, Craig Hoesley6, Ken Ho7, Sherri Johnson8, Jonathan Lucas8, Nicole Macagna8, Elizabeth Brown3, Holly Gundacker3, Melissa Peda3, Cindy E Jacobson9, Lindsay Kramzer9, Devika Singh9, Charlene S Dezzutti9,7, Ratiya Pamela Kunjara Na Ayudhya9, Mark A Marzinke10, Jeanna Piper11, Bríd Devlin12, Jeremy Nuttall12, Ian McGowan7, Craig W Hendrix9,10, Ross D Cranston13.   

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.
© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Entities:  

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

Mesh:

Substances:

Year:  2021        PMID: 34657218      PMCID: PMC9024063          DOI: 10.1007/s10461-021-03490-8

Source DB:  PubMed          Journal:  AIDS Behav        ISSN: 1090-7165


  35 in total

1.  Rectal-specific microbicide applicator: evaluation and comparison with a vaginal applicator used rectally.

Authors:  Alex Carballo-Diéguez; Rebecca Giguere; Curtis Dolezal; José Bauermeister; Cheng-Shiun Leu; Juan Valladares; Lisa C Rohan; Peter A Anton; Ross D Cranston; Irma Febo; Kenneth Mayer; Ian McGowan
Journal:  AIDS Behav       Date:  2014-09

Review 2.  Understanding, Contextualizing, and Addressing PrEP Stigma to Enhance PrEP Implementation.

Authors:  Sarah K Calabrese
Journal:  Curr HIV/AIDS Rep       Date:  2020-09-23       Impact factor: 5.071

3.  Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial.

Authors:  Rebecca Giguere; Christine Tagliaferri Rael; Alan Sheinfil; Ivan C Balán; William Brown; Titcha Ho; Curtis Dolezal; Cheng-Shiun Leu; Albert Liu; Kenneth H Mayer; Javier R Lama; Ian McGowan; Alex Carballo-Diéguez; Ross D Cranston
Journal:  AIDS Behav       Date:  2018-02

4.  Acceptability of a Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-033 Study).

Authors:  José A Bauermeister; Ryan C Tingler; Sherri Johnson; Nicole Macagna; Jonathan Lucas; Clara Dominguez-Islas; Daniel Szydlo; Julie Ngo; Cindy E Jacobson; Lindsay Kramzer; Devika Singh; Charlene S Dezzutti; Ratiya Pamela Kunjara Na Ayudhya; Jeanna Piper; Bríd Devlin; Craig W Hendrix; Ken Ho
Journal:  AIDS Educ Prev       Date:  2021-10

Review 5.  Use of antiretrovirals for HIV prevention: what do we know and what don't we know?

Authors:  Jared M Baeten; Robert Grant
Journal:  Curr HIV/AIDS Rep       Date:  2013-06       Impact factor: 5.071

Review 6.  The development of rectal microbicides for HIV prevention.

Authors:  Ian McGowan
Journal:  Expert Opin Drug Deliv       Date:  2013-11-25       Impact factor: 6.648

7.  Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women.

Authors:  Annalene Nel; Neliëtte van Niekerk; Saidi Kapiga; Linda-Gail Bekker; Cynthia Gama; Katherine Gill; Anatoli Kamali; Philip Kotze; Cheryl Louw; Zonke Mabude; Nokuthula Miti; Sylvia Kusemererwa; Hugo Tempelman; Hannelie Carstens; Brid Devlin; Michelle Isaacs; Mariëtte Malherbe; Winel Mans; Jeremy Nuttall; Marisa Russell; Smangaliso Ntshele; Marlie Smit; Leonard Solai; Patrick Spence; John Steytler; Kathleen Windle; Maarten Borremans; Sophie Resseler; Jens Van Roey; Wim Parys; Tony Vangeneugden; Ben Van Baelen; Zeda Rosenberg
Journal:  N Engl J Med       Date:  2016-12-01       Impact factor: 91.245

8.  Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa.

Authors:  Annalene Nel; Linda-Gail Bekker; Elizabeth Bukusi; Elizabeth Hellstrӧm; Philip Kotze; Cheryl Louw; Francis Martinson; Gileard Masenga; Elizabeth Montgomery; Nelisiwe Ndaba; Ariane van der Straten; Neliëtte van Niekerk; Cynthia Woodsong
Journal:  PLoS One       Date:  2016-03-10       Impact factor: 3.240

9.  The Promise of Intravaginal Rings for Prevention: User Perceptions of Biomechanical Properties and Implications for Prevention Product Development.

Authors:  Kate Morrow Guthrie; Sara Vargas; Julia G Shaw; Rochelle K Rosen; Jacob J van den Berg; Patrick F Kiser; Karen Buckheit; Dana Bregman; Lara Thompson; Kathleen Jensen; Todd Johnson; Robert W Buckheit
Journal:  PLoS One       Date:  2015-12-22       Impact factor: 3.240

10.  How to Construct a Mixed Methods Research Design.

Authors:  Judith Schoonenboom; R Burke Johnson
Journal:  Kolner Z Soz Sozpsychol       Date:  2017-07-05
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  1 in total

Review 1.  Promise, perils and cautious optimism: the next frontier in long-acting modalities for the treatment and prevention of HIV.

Authors:  Morgan M Philbin; Amaya Perez-Brumer
Journal:  Curr Opin HIV AIDS       Date:  2022-03-01       Impact factor: 4.283

  1 in total

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