Dr. Cathy Reback Receives R01 Award
FRI is pleased to announce that Dr. Cathy Reback, along with Co-Investigators Drs. Jesse Fletcher, also from FRI, and Adam Carrico from University of Miami, have received a grant from the National Institute on Drug Abuse entitled, “Getting Off: A Theory-based mHealth Intervention for Methamphetamine-using Men who Have Sex with Men (MSM).” The Phase II study builds upon the established efficacy of Drs. Reback’s and Steve Shoptaw’s group-based manualized methamphetamine abuse treatment intervention, “Getting Off: A Behavioral Treatment Intervention for Gay and Bisexual Male Methamphetamine Users,” and the highly promising findings from the successful Stage I proof-of-concept study conducted by Drs. Reback, Carswell, Gryczynski, and Fletcher. This five-year study will complete translation of the Getting Off group-based manual into a cross-platform (iOS and Android) mobile app and assess the app’s efficacy and non-inferiority in a randomized controlled trial (RCT). The Getting Off app, like the group-based intervention before it, will use the principles of Cognitive Behavioral Theory and Stages of Change to help MSM reduce or eliminate methamphetamine 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). Following the development of the group-based Getting Off intervention into a cross-platform computerized mobile app, including formative work and a feasibility pilot test, the study will conduct a RCT trial to evaluate reductions of methamphetamine use and HIV sexual risk behaviors, and increased advancement along the HIV Prevention or Care Continuum, using three approaches: a) Efficacy Trial – a two-arm RCT to determine intervention effects through comparison of the Immediate Delivery (ID; n=150) and Delayed Delivery (DD; n=150) arms; b) Efficacy Trial – an observed treatment effects analysis to compare pre/post data from the pooled ID and DD conditions (N=300); and, c) Non-inferiority Trial – a two-arm historical matched comparison design to evaluate the outcomes of the Getting Off app (ID + DD; N=300) relative to a matched sample of participants having previously attended the brick-and-mortar, group-based Getting Off intervention (N~600; total N=900). The RCT uses repeated measures to assess participants at baseline, 1-, 2- (DD condition only), 3-, 6-, and 9-month follow-up. This study could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent and highly scalable methamphetamine treatment to this very high-risk population.