Abstract In 2019 men who have sex with men (MSM) accounted for 70% of the 34,800 new HIV diagnoses and 66% of the 1.2 million total HIV infections in the United States. Among this high priority population, MSM living with HIV, stimulant use is a major barrier to achieving viral load control, necessary for reducing HIV transmission and improving long term health outcomes. Additionally, having HIV and substance use disorder diagnoses, as well as being racial/ethnic minority MSM, exacerbate the barriers to accessing and completing in-person drug treatment services. reSET is the first FDA approved prescription mobile therapeutic software designed to treat substance use disorders in adults. In patients with a primary diagnosis of stimulant use disorder, reSET has been found efficacious in reducing stimulant use, both for patients who are already in drug treatment and as a standalone substance use treatment for incarcerated persons. However, reSET has not been tested in any medical settings, including HIV care settings, as an all-virtual SUD treatment for patients living with HIV. To effectively mitigate the HIV epidemic among ethnically diverse MSM living with HIV, we propose a two-arm RCT of an all-virtual 12-week stimulant disorder treatment for MSM living with HIV who are on antiretroviral therapy (ART). The study will include 426 racial/ethnically diverse MSM (~50% African American and ~23% Latinx). Participants will be patients of the AIDS Healthcare Foundation (AHF) HIV treatment centers (10 participating clinics) located in four US metro areas with AHF’s highest numbers of HIV cases with stimulant use (Atlanta, Dallas/Fort Worth, Fort Lauderdale and Los Angeles). Participants with moderate to severe stimulant use disorder will be randomized to two conditions: (1) referral to outpatient substance use disorder treatment (treatment as usual/ control condition) or (2) reSET (experimental condition) to: (Aim 1a) test the effectiveness of standalone all-virtual reSET in achieving lower stimulant use across 3-, 9- and 15-months compared to TAU; (Aim 1b) test the effectiveness of standalone all-virtual reSET in increasing the likelihood of viral suppression across the 3-, 9- and 15-months follow-up periods compared to TAU; (Aim 2) examine the moderating effect of race/ethnicity (Blacks/African Americans, Latinx, and Whites) on the relationship between condition and stimulant use (primary outcome) and VL suppression (secondary outcome); and (Aim 3) to evaluate in the context of the RE-AIM framework, the reach, effectiveness, adoption, implementation, economic impact, and implementation maintenance of the experimental treatment within AHF. If found effective, reSET implemented in conjunction ART could, present a major scalable advancement in optimizing ‘treatment as prevention’ among sexual minorities living with HIV and stimulant use disorder.

Project Narrative This study will examine, within HIV medical care settings, the effectiveness and implementation of reSET (the first FDA approved prescription mobile therapeutic software for the treatment of substance use disorders in adult patients) as a standalone all-virtual stimulant use treatment for racial/ethnically diverse MSM living with HIV. Compared to referral to outpatient substance use disorder treatment, this study will evaluate (1) reSET’s effectiveness in achieving lower stimulant use and increasing the likelihood of viral load suppression in the follow-up period from 3 to 15 months, (2) the moderating effect of race/ethnicity on the impact of condition on stimulant use and viral load suppression, and (3) the reach, adoption, implementation (plus economic impact), and implementation maintenance of reSET in an HIV healthcare system. If effective, reSET implemented in conjunction with antiretroviral therapy could present a major scalable advancement in improving HIV treatment as prevention among stimulant-using sexual minorities living with HIV.