Bauermeister José A, Lin Willey, Webster Jessica, Listerud Louis L, Burgese Tyler, Agwu Allison, Lewis Jessica Coleman, Anderson Thuy, Hightow-Weidman Lisa, Hendrix Craig, Arrington-Sanders Renata
University of Pennsylvania, Philadelphia, PA, USA.
Johns Hopkins University, Baltimore, MD, USA.
AIDS Behav. 2025 May 29. doi: 10.1007/s10461-025-04763-2.
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.
与男性发生性行为的年轻男性（YMSM）受艾滋病毒的影响仍然不成比例，但每日口服暴露前预防（PrEP）的依从性仍然不理想。以灌洗方式配制的直肠杀菌剂通过利用现有的灌洗做法提供了一种行为上一致的替代方案。本研究评估了一种基于替诺福韦的直肠杀菌剂灌洗剂在YMSM中的可接受性。八名YMSM（平均年龄M = 20.9岁；范围18 - 24岁）参与了一项I期开放标签单臂试验，评估在125毫升直肠灌洗剂中单次给予600毫克替诺福韦的安全性、药代动力学和耐受性（NCT04686279）。这项混合方法研究包括给药后行为调查和定性深入访谈（IDI），以评估产品的可接受性、耐受性和对其可用性的看法。访谈内容被转录、编码并进行主题分析。描述性统计总结了参与者特征、灌洗行为以及在不同情况下使用该产品的意愿。参与者报告直肠杀菌剂灌洗剂的可接受性很高，特别是其易用性以及与现有性健康常规的融合性。大多数（87.5%）表示他们会认为该产品可用于预防艾滋病毒，75%报告他们可能会在每次接受肛交（RAI）事件前使用它。这种间歇性给药方案被认为是一个优点，特别是对于偶然的性接触。障碍包括对产品设计的担忧、隐私和成本。直肠杀菌剂灌洗剂在YMSM中具有很高的可接受性，支持其作为一种新型艾滋病毒预防策略的潜力。研究结果强调了行为上一致的干预措施的重要性，并突出了未来产品开发的关键考虑因素，包括改进包装、可承受性和可及性。试验注册号：NCT04686279。
