Assessing the Acceptability of a Tenofovir-Based Rectal Microbicide Douche among Young Men who Have Sex with Men: Results from ATN-DREAM (ATN 163).

IF 2.7 2区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
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
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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.

评估年轻男男性行为者对替诺福韦直肠杀微生物剂的可接受性:来自ATN- dream (ATN 163)的结果。
男男性行为的年轻男性(YMSM)仍然不成比例地受到艾滋病毒的影响,但坚持每日口服暴露前预防(PrEP)仍然不是最佳选择。直肠杀菌剂配制为冲洗提供了一种行为一致的替代方案,利用现有的冲洗做法。本研究评估了一种基于替诺福韦的直肠杀微生物剂在男性男性中的可接受性。8个YMSM (M = 20.9年;年龄在18-24岁之间)参加了一项I期、开放标签、单臂试验,评估单次600mg替诺福韦125mL直肠灌洗(NCT04686279)的安全性、药代动力学和耐受性。这项混合方法的研究包括给药后行为调查和定性深入访谈(IDIs),以评估产品的可接受性、耐受性和对产品可用性的看法。采访被转录、编码并按主题进行分析。描述性统计总结了参与者的特征、冲洗行为和在不同情况下使用该产品的意愿。参与者报告了直肠杀微生物剂灌洗液的高可接受性,特别是其易于使用和融入现有的性健康程序。大多数人(87.5%)表示,他们认为该产品可用于预防艾滋病毒,75%的人表示,他们可能会在每次接受性肛交(RAI)活动之前使用该产品。断断续续的给药方案被认为是有益的,特别是对于随意的性接触。障碍包括产品设计、隐私和成本。直肠杀微生物剂灌洗液在男性男性中被高度接受,支持其作为一种新的艾滋病毒预防策略的潜力。研究结果强调了行为一致性干预的重要性,并强调了未来产品开发的关键考虑因素,包括改进包装、可负担性和可及性。试验注册:NCT04686279。
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来源期刊
AIDS and Behavior
AIDS and Behavior Multiple-
CiteScore
6.60
自引率
13.60%
发文量
382
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
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