Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 1, 2025
Date Accepted: Sep 24, 2025
Optimizing an App-Based Just-in-Time Adaptive Intervention for Stimulant Using Sexual Minority Men Living with HIV: Protocol for a Community Engaged Research Approach and Hybrid-Experimental Design
ABSTRACT
Background:
In the United States, sexual minority men (SMM) are disproportionately affected by HIV. For this population, intersecting sexual minority and HIV-related stress add to general life stressors to increase health risks. Stress is associated with HIV progression and is linked to transmission risk behaviors (e.g. medication non-adherence and substance use). Substance use is a particularly important risk factor for HIV transmission. In addition to injection drug use risk, recreational use is associated with sexual transmission risk behaviors and increased risk for HIV among SMM. Interventions targeting stress response may be particularly useful for HIV risk reduction among substance-using SMM (SUSMM) living with HIV (LWH). Positive affect interventions have shown promise in reducing stress in the context of chronic illness, including HIV. However, few studies have examined these interventions and their potential health benefits for SUSMM-LWH.
Objective:
This protocol is for a project (R34DA053999) which builds on our pilot work in the area of positive affect induction as a potential intervention approach to reduce stress and improve health outcomes among SMM-LWH. The aim of our protocol is to take a community-engaged research (CEnR) approach, using the multiphase optimization strategy (MOST), to iteratively tailor our app-based positive affect intervention, TeaTime, for SUSMM-LWH.
Methods:
In Phase 1, we enrolled 10 SUSMM-LWH into an open phase pilot using our existing app-based ecological momentary intervention (EMI), which uses a just-in-time adaptive intervention (JITAI) design. We worked alongside a community advisory board to tailor our intervention content and app design, using focus group feedback. In Phase 2, we are conducting a pilot factorial optimization trial to assess acceptability and feasibility of adding two new features that may enhance our intervention design and delivery. Specifically, we implement a 2x2 factorial design, randomizing 80 SUSMM-LWH to receive (1) random craving prompts and/or (2) smart watch integration.
Results:
The project was funded February 2022 and data collection for Phase 1 was completed in December 2023. Phase 2 was launched July 2024, and data collection is ongoing. The results for Phase 1 are expected to be submitted for publication by August 2025.
Conclusions:
In this protocol we combine methods from social science, intervention science, and software development into one innovative approach to enhance and optimize an app-based, just-in-time-adaptive, ecological momentary intervention with SUSMM-LWH. Findings from this study will aid us in arriving at a fully optimized intervention ready for evaluation and implementation. In a future RCT, the ecological momentary assessment (EMA) design will also allow us to collect day-level data on intervention efficacy
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