José A Bauermeister, Willey Lin, Jessica Webster, Louis L Listerud, Tyler Burgese, Allison Agwu, Jessica Coleman Lewis, Thuy Anderson, Lisa Hightow-Weidman, Craig Hendrix, Renata Arrington-Sanders
{"title":"Assessing the Acceptability of a Tenofovir-Based Rectal Microbicide Douche among Young Men who Have Sex with Men: Results from ATN-DREAM (ATN 163).","authors":"José A Bauermeister, Willey Lin, Jessica Webster, Louis L Listerud, Tyler Burgese, Allison Agwu, Jessica Coleman Lewis, Thuy Anderson, Lisa Hightow-Weidman, Craig Hendrix, Renata Arrington-Sanders","doi":"10.1007/s10461-025-04763-2","DOIUrl":null,"url":null,"abstract":"<p><p>Young men who have sex with men (YMSM) remain disproportionately affected by HIV, yet adherence to daily oral pre-exposure prophylaxis (PrEP) remains suboptimal. Rectal microbicides formulated as douches offer a behaviorally congruent alternative by leveraging existing douching practices. This study assessed the acceptability of a tenofovir-based rectal microbicide douche among YMSM. Eight YMSM (M = 20.9 years; range 18-24 years) participated in a Phase I, open-label, single-arm trial evaluating the safety, pharmacokinetics, and tolerability of a single 600 mg dose of tenofovir delivered in a 125mL rectal douche (NCT04686279). This mixed-methods study included post-dosing behavioral surveys and qualitative in-depth interviews (IDIs) to assess acceptability, tolerability, and perceptions of the product's usability. Interviews were transcribed, coded, and analyzed thematically. Descriptive statistics summarized participant characteristics, douching behaviors, and willingness to use the product in different contexts. Participants reported high acceptability of the rectal microbicide douche, particularly its ease of use and integration into existing sexual health routines. Most (87.5%) indicated they would find the product acceptable for HIV prevention, and 75% reported they would likely use it before every receptive anal intercourse (RAI) event. The episodic dosing regimen was perceived as a benefit, especially for casual sexual encounters. Barriers included product design concerns, privacy, and cost. A rectal microbicide douche was highly acceptable among YMSM, supporting its potential as a novel HIV prevention strategy. Findings underscore the importance of behaviorally congruent interventions and highlight key considerations for future product development, including improved packaging, affordability, and accessibility.Trials Registration: NCT04686279.</p>","PeriodicalId":7543,"journal":{"name":"AIDS and Behavior","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"AIDS and Behavior","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10461-025-04763-2","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Young men who have sex with men (YMSM) remain disproportionately affected by HIV, yet adherence to daily oral pre-exposure prophylaxis (PrEP) remains suboptimal. Rectal microbicides formulated as douches offer a behaviorally congruent alternative by leveraging existing douching practices. This study assessed the acceptability of a tenofovir-based rectal microbicide douche among YMSM. Eight YMSM (M = 20.9 years; range 18-24 years) participated in a Phase I, open-label, single-arm trial evaluating the safety, pharmacokinetics, and tolerability of a single 600 mg dose of tenofovir delivered in a 125mL rectal douche (NCT04686279). This mixed-methods study included post-dosing behavioral surveys and qualitative in-depth interviews (IDIs) to assess acceptability, tolerability, and perceptions of the product's usability. Interviews were transcribed, coded, and analyzed thematically. Descriptive statistics summarized participant characteristics, douching behaviors, and willingness to use the product in different contexts. Participants reported high acceptability of the rectal microbicide douche, particularly its ease of use and integration into existing sexual health routines. Most (87.5%) indicated they would find the product acceptable for HIV prevention, and 75% reported they would likely use it before every receptive anal intercourse (RAI) event. The episodic dosing regimen was perceived as a benefit, especially for casual sexual encounters. Barriers included product design concerns, privacy, and cost. A rectal microbicide douche was highly acceptable among YMSM, supporting its potential as a novel HIV prevention strategy. Findings underscore the importance of behaviorally congruent interventions and highlight key considerations for future product development, including improved packaging, affordability, and accessibility.Trials Registration: NCT04686279.
期刊介绍:
AIDS and Behavior provides an international venue for the scientific exchange of research and scholarly work on the contributing factors, prevention, consequences, social impact, and response to HIV/AIDS. This bimonthly journal publishes original peer-reviewed papers that address all areas of AIDS behavioral research including: individual, contextual, social, economic and geographic factors that facilitate HIV transmission; interventions aimed to reduce HIV transmission risks at all levels and in all contexts; mental health aspects of HIV/AIDS; medical and behavioral consequences of HIV infection - including health-related quality of life, coping, treatment and treatment adherence; and the impact of HIV infection on adults children, families, communities and societies. The journal publishes original research articles, brief research reports, and critical literature reviews. provides an international venue for the scientific exchange of research and scholarly work on the contributing factors, prevention, consequences, social impact, and response to HIV/AIDS. This bimonthly journal publishes original peer-reviewed papers that address all areas of AIDS behavioral research including: individual, contextual, social, economic and geographic factors that facilitate HIV transmission; interventions aimed to reduce HIV transmission risks at all levels and in all contexts; mental health aspects of HIV/AIDS; medical and behavioral consequences of HIV infection - including health-related quality of life, coping, treatment and treatment adherence; and the impact of HIV infection on adults children, families, communities and societies. The journal publishes original research articles, brief research reports, and critical literature reviews.5 Year Impact Factor: 2.965 (2008) Section ''SOCIAL SCIENCES, BIOMEDICAL'': Rank 5 of 29 Section ''PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH'': Rank 9 of 76