Arnold Trisha, Giorlando Kayla K, Barnett Andrew P, Gaudiano Brandon A, Antonaccio Cara M, Elwy A Rani, Patrick Edet Precious, Ward Lori M, Whiteley Laura, Bailey Sarah, Rogers Brooke G, Leigland Avery, Rusley Jack C, Brown Larry K
Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.
Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, United States.
JMIR Res Protoc. 2025 Jun 20;14:e65921. doi: 10.2196/65921.
BACKGROUND: Given the high rates of HIV infection among young Black men who have sex with men in Jackson, Mississippi, and the underuse of pre-exposure prophylaxis (PrEP) in this population, there is a critical need for innovative interventions to promote PrEP use. Acceptance and commitment therapy (ACT) is a promising intervention for health behavior change. OBJECTIVE: This study aims to develop and test an intervention, ACTPrEP, to increase PrEP use among young Black men who have sex with men. METHODS: We conducted in-depth interviews with 20 young Black men who have sex with men and 10 PrEP staff to inform the development of ACTPrEP, an intervention that uses ACT to improve PrEP use. Specific ACTPrEP adaptations from the qualitative interviews included service settings (interventionists should be PrEP informed and well-integrated), target audiences (provide check-in calls, be caring, and authentically relate), modes of delivery (flexible delivery), and cultural adaptation (normalize PrEP use). A pilot randomized controlled trial will evaluate the feasibility and acceptability of ACTPrEP compared to that of Enhanced Standard of Care in promoting PrEP use among young Black men who have sex with men (N=66). We will specifically evaluate group differences in the proportion of participants who initiate PrEP, PrEP adherence, and PrEP persistence. Measures will be collected at baseline, 6 weeks, and 12 weeks. RESULTS: Research activities began in September 2023 and will be ongoing through June 2026. Preliminary findings are anticipated to be available in late 2026. CONCLUSIONS: This study will inform the development of a larger randomized controlled trial to evaluate the efficacy of ACTPrEP for increasing PrEP use among young Black men who have sex with men. TRIAL REGISTRATION: ClinicalTrials.gov NCT05087680; https://clinicaltrials.gov/study/NCT05087680. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65921.
背景：鉴于密西西比州杰克逊市与男性发生性关系的年轻黑人男性中艾滋病毒感染率较高，且该人群中暴露前预防（PrEP）的使用率较低，迫切需要创新干预措施来促进PrEP的使用。接纳与承诺疗法（ACT）是一种有前景的促进健康行为改变的干预方法。 目的：本研究旨在开发并测试一种名为ACTPrEP的干预措施，以提高与男性发生性关系的年轻黑人男性对PrEP的使用。 方法：我们对20名与男性发生性关系的年轻黑人男性和10名PrEP工作人员进行了深入访谈，为ACTPrEP的开发提供依据，ACTPrEP是一种利用ACT来改善PrEP使用情况的干预措施。从定性访谈中得出的ACTPrEP的具体调整包括服务环境（干预人员应了解PrEP并能很好地融入其中）、目标受众（进行跟进电话、关心他人并真诚相处）、交付方式（灵活交付）和文化适应（使PrEP的使用常态化）。一项试点随机对照试验将评估ACTPrEP与强化标准护理相比，在促进与男性发生性关系的年轻黑人男性中使用PrEP的可行性和可接受性（N = 66）。我们将具体评估开始使用PrEP的参与者比例、PrEP依从性和PrEP持续性方面的组间差异。在基线、6周和12周时收集测量数据。 结果：研究活动于2023年9月开始，将持续到2026年6月。预计2026年末可获得初步研究结果。 结论：本研究将为开展一项更大规模的随机对照试验提供依据，以评估ACTPrEP在增加与男性发生性关系的年轻黑人男性中使用PrEP的疗效。 试验注册：ClinicalTrials.gov NCT05087680；https://clinicaltrials.gov/study/NCT05087680。 国际注册报告识别码（IRRID）：DERR1-10.2196/65921。
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