reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

University Of Miami School Of Medicine, Coral Gables FL

Investigators

Linked publications, trials & patents

Abstract

In 2019, there were approximately 1.2 million people living with HIV in the United States. 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 exacerbate the barriers to accessing and completing in-person drug treatment services. reSET is the first FDA approved prescription digital therapeutic 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 substance use 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 standalone stimulant use disorder treatment for patients living with HIV. To effectively mitigate the HIV epidemic among persons living with HIV, we propose a two-arm RCT of an all-virtual 12-week stimulant disorder treatment for persons living with HIV who are on antiretroviral therapy (ART). The study will randomize 426 participants who are patients of participating HIV healthcare centers in US metro areas with the highest rates of HIV cases with stimulant use. The participants will be randomized to one of two conditions: (1) referral to outpatient substance use disorder treatment (treatment as usual/ control condition) or (2) reSET (experimental condition) to: (Aim 1a, primary outcome) Investigate the effectiveness of reSET in achieving lower stimulant use and (Aim 1b, secondary outcome) higher proportion of viral suppression at 3-, 9 and 15-months compared to treatment as usual; (Aim 2) Test for differentiators of reSET’s effectiveness on stimulant use and viral load suppression; and (Aim 3) In the context of the RE-AIM framework, evaluate the reach, effectiveness, adoption, implementation (including cost-effectiveness), and maintenance of reSET. If effective, reSET implemented in conjunction with antiretroviral therapy among people living with HIV and stimulant use disorder, could present a major scalable advancement in improving HIV treatment as prevention.