Novel Machine Learning HIV Intervention for Sexual and Gender Minority Young People Who Have Sex With Men (uTECH): Protocol for a Randomized Comparison Trial

Abstract

Background: Sexual and gender minority (SGM) young people are disproportionately affected by HIV in the United States, and substance use is a major driver of new infections. People who use web-based venues to meet sex partners are more likely to report substance use, sexual risk behaviors, and sexually transmitted infections. To our knowledge, no machine learning (ML) interventions have been developed that use web-based and digital technologies to inform and personalize HIV and substance use prevention efforts for SGM young people.

Objective: This study aims to test the acceptability, appropriateness, and feasibility of the uTECH intervention, a SMS text messaging intervention using an ML algorithm to promote HIV prevention and substance use harm reduction among SGM people aged 18 to 29 years who have sex with men. This intervention will be compared to the Young Men's Health Project (YMHP) alone, an existing Centers for Disease Control and Prevention best evidence intervention for young SGM people, which consists of 4 motivational interviewing-based counseling sessions. The YMHP condition will receive YMHP sessions and will be compared to the uTECH+YMHP condition, which includes YMHP sessions as well as uTECH SMS text messages.

Methods: In a study funded by the National Institutes of Health, we will recruit and enroll SGM participants (aged 18-29 years) in the United States (N=330) to participate in a 12-month, 2-arm randomized comparison trial. All participants will receive 4 counseling sessions conducted over Zoom (Zoom Video Communications, Inc) with a master's-level social worker. Participants in the uTECH+YMHP condition will receive curated SMS text messages informed by an ML algorithm that seek to promote HIV and substance use risk reduction strategies as well as undergoing YMHP counseling. We hypothesize that the uTECH+YMHP intervention will be considered acceptable, appropriate, and feasible to most participants. We also hypothesize that participants in the combined condition will experience enhanced and more durable reductions in substance use and sexual risk behaviors compared to participants receiving YMHP alone. Appropriate statistical methods, models, and procedures will be selected to evaluate primary hypotheses and behavioral health outcomes in both intervention conditions using an α<.05 significance level, including comparison tests, tests of fixed effects, and growth curve modeling.

Results: This study was funded in August 2019. As of June 2024, all participants have been enrolled. Data analysis has commenced, and expected results will be published in the fall of 2025.

Conclusions: This study aims to develop and test the acceptability, appropriateness, and feasibility of uTECH, a novel approach to reduce HIV risk and substance use among SGM young adults.

Trial registration: ClinicalTrials.gov NCT04710901; https://clinicaltrials.gov/study/NCT04710901.

International registered report identifier (irrid): DERR1-10.2196/58448.

Keywords: HIV; YMHP; Young Men’s Health Project; harm reduction; mHealth; machine learning; mobile app; mobile health; mobile phone; motivational interviewing; sexual and gender minority; substance use; text messaging.