Factorial optimization trial protocol of a JITAI app for stimulant cravings and minority stress in SMM living with HIV

For sexual minority men (SMM) living with HIV (LWH) intersectional sexual minority and HIV-related stress add to general life stressors to increase health risk, including substance use and other HIV TRB. Intersectional minority stress also contributes to significant mental health disparities among SMM LWH. Interventions targeting stress may improve mental health, as well as promote HIV risk reduction among substance-using (SU) SMM LWH. This project builds on a proof-of-concept pilot where we adapted a positive psychological intervention for app delivery, using a just-in-time adaptive intervention (JITAI) design to address intersectional minority stress among SMM LWH.

This study takes a community-engaged research approach and uses the multiphase optimization strategy (MOST) to adapt our exisiting JITAI for SUSMM-LWH. As part of the “preparation phase” of MOST, we enrolled eight SUSMM-LWH in a open-phase pilot to use our app for 90 days. App-adaption was an iterative process, where we met with participants every 30-days to receive feedback on the app. We worked with a community advisory board, which met with us after each focus group to review participant feedback and make decisions regarding app adaptation. Changes to the app were made in real-time during “programming sprints”, allowing participants to test the new app features between focus group sessions. After this pilot, we finalized the app updates and began beta testing. We recently finalized the app and are preparing to launch the next phase of this study. As part of the “optimization phase” of MOST, we will conduct a microrandomized trial (MRT) embedded within a factorial optimization trial. To do this, we will enroll 80 SUSMM-LWH in 2x2 factorial optimization trial of the app for 90-days to assess the acceptability and feasibility of adding two new app features to our JITAI app: random craving prompts and smart watch integration. As part of the MRT, all participants will experience microrandomization of JITAI activities within the app over the 90 days. Specifically, when participant’s report stress or cravings in the EMA, they will be microrandomized at a 2:1 ratio to receive a JITAI activity. Participants will complete a blood draw at baseline and the three-month follow-up assessment, as well as provide a hair sample. Participants will also complete a brief qualitative interview at the follow-up assessment to assess acceptability and feasibility of the adapted app.    

Findings from this mixed-methods study consist of quantitative self-report data for app usability and acceptability, objective data on app engagement (e.g., frequency of use, EMA compliance, JITAI activity completion), and qualitative interview data. Further, we will examine feasibility and acceptability of hair sample collection and blood draws. Analyses will also be conducted to examine preliminary efficacy using objective biological and biometric outcome data (CD4, Viral Load, watch data) as well as self-report data.