Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 16, 2020
Date Accepted: Jan 21, 2021
A Theory-based mHealth Intervention for Methamphetamine-using MSM: Study Protocol for a Randomized Controlled Trial (Getting Off)
ABSTRACT
Background:
Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased rates of HIV prevalence and transmission, as well as substandard advancement along the HIV Prevention and Care Continua. Meth use among MSM is deeply integrated into socio-sexual networks including the use of smartphone applications (“app”) and websites to find sexual partners. Given the growth of mobile health (mHealth) technology, it is no longer necessary or reasonable to limit meth treatment options to physical sites, clustered in urban areas, and administered using generic, non-tailored content.
Objective:
In a two-arm randomized controlled trial (N=300), Getting Off will assess the impact and non-inferiority of a cross-platform app (developed from an established manualized Getting Off meth treatment intervention) to help MSM (18 to 65 years) reduce or eliminate meth use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum including uptake of HIV testing, pre-, and post-exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive.
Methods:
Participants will be randomized into one of two arms: Arm A: Immediate access to the Getting Off app (Immediate Delivery [ID]: n=150); or Arm B: Participants will have access to the Getting Off app after a delayed 30-day period (Delayed Delivery [DD]: n=150). Participants in both arms will receive the same Getting Off app and participants in both arms will be given 30-days to complete the 24 sessions. The randomized two-arm repeated measures design will assess participants at 1-, 2- (DD arm only), 3-, 6-, and 9-months post-randomization to determine longitudinal intervention effects, overserved treatment effects, and a historical comparison with a matched sample of participants (n=600) who have attended 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, four separate focus groups (N=36) were conducted to provide input on the adaptation of the Getting Off group-based manual to a cross-platform computerized mobile app. The data collection for Phase 2, the randomized controlled trial, is expected to be completed in January 2023. Final results are anticipated for April 2023.
Conclusions:
By creating a culturally responsive, cross-platform computerized mobile app, Getting Off aims to reduce methamphetamine use and improve sexual health outcomes among meth-using MSM. Given the severe personal and public health consequences of meth use, 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 and other high-risk populations. Clinical Trial: ClinicalTrials.gov Identifier: NCT03884946 https://clinicaltrials.gov/ct2/show/NCT03884946
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