Dr. Cathy Reback Receives R01 Award
FRI is pleased to announce that Dr. Cathy Reback, along with Dr. Sean Murphy from Weill Cornell Medical College (MPIs), have received a five-year R01 grant from the National Institute on Drug Abuse entitled, “Optimizing PrEP Implementation and Cost-effectiveness among Sexual and Gender Minority Individuals with a Substance Use Disorder.” In addition to Drs. Reback and Murphy, the interdisciplinary investigative team of experts includes Drs. Steve Shoptaw and Raphael J. Landovitz (UCLA), David Benkeser (Emory University), and Ali Jalali (Weill Cornell Medical College). This study builds upon the highly promising findings from our open-label Phase I A.S.K.-PrEP (Assistance Services Knowledge-PrEP) pilot, which utilized PrEP navigation with text message (SMS) support to increase PrEP initiation among transgender women (TW) and men who have sex with men (MSM). This Phase II study will implement a RCT with a Stepped Care design of ASK-PREP vs. standard of care (SOC) to determine optimal intervention response among TW/MSM with a Substance Use Disorder (SUD; N=285; n=95 TW; n=190 MSM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n=214) or SOC (n=71). Participants in the Stepped Care arm receive the same ASK-PrEP intervention that was delivered in the pilot study and will be assessed at 3-months for intervention response; responders will be maintained in ASK-PrEP, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone). The specific aims are to: 1) Evaluate a Stepped Care approach promoting advancement along the PrEP Care Continuum and reductions in substance use among TW/MSM with a SUD; 2) Estimate the cost of implementing and sustaining each intervention and conduct a cost-effectiveness analysis to determine the value of each intervention relative to SOC, and to each other, from the healthcare-sector, state-policymaker, and societal perspectives; Secondary Aim 1) Determine the individual effects of specific substances, routes of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators of outcomes; and Exploratory Aim) Evaluate intervention engagement and response by chosen PrEP modality (oral daily or long-acting injectable). The “intent-to-treat” RCT uses repeated assessments at baseline and at 3-, 6-, 9-, and 12-months post enrollment. Although PrEP is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes, and the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. Thus, this Phase II RCT could have significant public health impact by identifying scalable and effective PrEP interventions that match intensity and participant needs to maximize efficacy while minimizing costs.