A Theory-based mHealth Intervention for Methamphetamine-using MSM: Study Protocol for a Randomized Controlled Trial (Getting Off) (Preprint)

BACKGROUND Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased HIV prevalence and transmission and substandard advancement along the HIV prevention and care continuum. Given the growth of mobile health (mHealth) technologies, it is no longer necessary to limit meth treatment options to physical, brick-and-mortar sites, and administration using generic, nontailored content. OBJECTIVE In a 2-arm randomized controlled trial (RCT; N=300), we aim to evaluate the use of an mHealth intervention (Getting Off) to assess the impact and noninferiority of a cross-platform app (developed from a manualized meth treatment intervention) to help MSM reduce meth use and HIV sexual risk behaviors and improve their advancement along the HIV prevention and care continuum (HIV testing, pre-exposure prophylaxis uptake and persistence, and antiretroviral therapy uptake and adherence). METHODS Participants will be randomized into 2 arms: arm A, with immediate access to the app (immediate delivery: n=150), or arm B, with delayed access to the app after a 30-day period (delayed delivery: n=150). Participants in both arms will use the same Getting Off app and will have 30 days to complete the 24 sessions. Participants will be assessed at the 1-, 2- (delayed delivery arm only), 3-, 6-, and 9-month timepoints to determine observed treatment effects and will be compared with a historical matched sample of participants (n=~600) who received the brick-and-mortar group-based Getting Off intervention. RESULTS Recruitment began in January 2019 for phase 1, the formative phase. In January and February 2019, 4 focus groups (N=36) were formed to provide input on the adaptation of the group-based manual intervention to a mobile app. Data collection for phase 2, the RCT, is expected to be completed in January 2023. The final results are anticipated in April 2023. CONCLUSIONS By creating a culturally responsive mobile app, Getting Off aims to reduce meth use and improve sexual health outcomes among meth-using MSM. The Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent, and highly scalable meth treatment for MSM. TRIAL REGISTRATION Clinicaltrials.gov NCT03884946; https://clinicaltrials.gov/ct2/show/NCT03884946. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/22572.