Ybarra M L, Feaster D J, Garofalo R, Bull S
Center for Innovative Public Health Research, San Clemente, CA, USA.
Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9.
Disparities in sexually transmitted infections (STI) including human immunodeficiency virus (HIV) among sexual minority boys and young men are substantial. Effective HIV and STI prevention programs that include access to pre-exposure prophylaxis (PrEP) medication do not consistently include younger sexual minority men. Text-messaging programs for HIV prevention have been associated with increases in HIV testing among sexual minority adolescent boys, but these programs have not incorporated a focus on PrEP or STIs beyond HIV.
We will conduct a two-arm randomized trial with 1:1 allocation comparing the superiority of text messaging-based intervention focused on HIV and STI prevention to a generic HIV education program with content focused on promoting a "healthy lifestyle" (e.g., self-esteem). Outcomes include testing for HIV and other STIs, increasing PrEP and PEP use, and HIV incidence. Generalized linear models will be used to estimate treatment effects on primary study outcomes, with longitudinal models (estimated based on Generalized Estimating Equations) specified to examine effects over time. Mediation will be assessed based on a product of coefficients approach with bootstrapped standard errors.
This is the first randomized controlled trial (RCT) with a national sample of cisgender sexual minority adolescent boys and young men 13-22 years of age exploring the efficacy of a text messaging-based intervention in increasing HIV and STI testing, and PReP and PEP use. Findings will inform the scalability of text messaging programs for sexual health promotion and at-home STI testing, and will demonstrate impacts of a behavioral health intervention on HIV incidence.
ClinicalTrials.gov NCT06230367 . Date of registration: 1/29/2024.
性少数群体男孩和年轻男性在包括人类免疫缺陷病毒（HIV）在内的性传播感染（STI）方面存在巨大差异。有效的HIV和STI预防项目，包括提供暴露前预防（PrEP）药物，但并不总是涵盖较年轻的性少数群体男性。针对HIV预防的短信项目与性少数群体青少年男孩的HIV检测增加有关，但这些项目并未将重点放在PrEP或HIV以外的性传播感染上。
我们将进行一项双臂随机试验，按1:1分配，比较以短信为基础、侧重于HIV和STI预防的干预措施与侧重于促进“健康生活方式”（如自尊）的通用HIV教育项目的优越性。结果包括HIV和其他性传播感染的检测、增加PrEP和暴露后预防（PEP）的使用以及HIV发病率。将使用广义线性模型估计对主要研究结果的治疗效果，并指定纵向模型（基于广义估计方程估计）来检查随时间的效果。将基于系数乘积法和自抽样标准误差评估中介作用。
这是第一项针对13至22岁顺性别性少数群体青少年男孩和年轻男性的全国性样本进行的随机对照试验（RCT），探讨基于短信的干预措施在增加HIV和STI检测以及PrEP和PEP使用方面的效果。研究结果将为性健康促进和家庭性传播感染检测的短信项目的可扩展性提供信息，并将证明行为健康干预对HIV发病率的影响。
ClinicalTrials.gov NCT06230367。注册日期：2024年1月29日。
