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, “Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression.” In addition to Drs. Reback and Murphy, the interdisciplinary investigative team of experts includes Drs. Tom Blue (FRI), Raphael J. Landovitz (UCLA), and Ali Jalali (Weill Cornell Medical College). This study builds on the promising findings from two HRSA-funded demonstration projects, The Alexis Project and Text Me, Girl!, which utilized Peer Health Navigation (PHN) and SMS (i.e., text messaging), respectively, for advancing trans women living with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative-effectiveness, required resources/costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with a SUD, have not been evaluated. This Phase II comparative-effectiveness RCT will randomize participants (N=225) into: PHN alone (n=75), SMS alone (n=75), or PHN+SMS (n=75). Using the same time points as the HRSA projects, the repeated-measures design will assess participants at baseline, 3-, 6-, 12-, and 18-months post-randomization. The specific aims are to: 1) Conduct a comparative effectiveness research trial to determine the relative effectiveness of PHN vs. SMS vs. PHN+SMS in terms of: Primary (a) virologic suppression; and Secondary outcomes (b) HIV Treatment Adherence Self-Efficacy Scale scores; (c) the AIDS Health Belief Scale scores; (d) the Inventory of Socially Supportive Behaviors scores; and (e) urine drug screen results; 2) Identify the resources required to prepare for, implement, and sustain each intervention, and estimate the associated costs; 3) Conduct a comprehensive cost-effectiveness analysis to determine the relative value of each intervention from the healthcare-sector, state-policymaker, and societal perspectives; and, a Secondary Aim to determine heterogeneous intervention effects across interventions due to social and structural determinants of health and individual-level characteristics. Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among trans women, and guiding service provision and public policy.

FRI’s community research site, Friends Community Center located in Hollywood, CA, was recently awarded the “Reducing Inequities in Priority Populations” grant funded through a partnership between Together Toward Health and Public Health Institute. Funding awarding aims to identify community-based organizations who provide services to populations disproportionately impacted by COVID-19 and Mpox. The project aims to serve hard-to-reach and historically underserved populations across Los Angeles County, specifically LGBTQ+ populations.

This project will focus on culturally appropriate outreach and engagement with LGBTQ+ individuals to increase good health outcomes surrounding COVID-19 and Mpox prevention and vaccination uptake. Direct service work with the communities will enable project staff to have two-way conversations to ensure personalized discussions, active listening, and wrap-around services to alleviate barriers to COVID-19 and Mpox vaccination.

FRI is pleased to announce that Dr. Shannon Gwin Mitchell (PI) was recently awarded a new R01 grant from the National Institute on Drug Abuse. The “Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology” study will examine the use of a digital contingency management delivery tool for people with opioid and cocaine polysubstance use receiving methadone treatment. FRI Co-investigators include Drs. Maxine Stitzer, Jan Gryczynski, and Jesse Fletcher. Methadone is a highly effective treatment for opioid use disorder, but many patients leave treatment prematurely, placing them at high risk of relapse and overdose. Extensive research shows that comorbid cocaine use is associated with poor retention in methadone treatment. The newly-funded study will examine a novel intervention designed to improve methadone treatment retention and other outcomes among people with opioid and cocaine polysubstance use. The design is a 2-arm randomized controlled trial comparing participants receiving treatment as usual from the participating methadone treatment programs with those receiving the DynamiCare Health Contingency Management (DCM) app in addition to their methadone treatment. The primary behaviors relevant to retention that will be targeted with incentives using the DCM program include abstinence from opioids and cocaine, as verified via remote oral fluid testing, and medication pickup from the methadone program, as verified by clinic records. Findings from this project can improve the public health impact of methadone treatment by identifying an effective and scalable approach to address polysubstance use among patients at heightened risk of treatment dropout.

FRI is pleased to announce that Dr. Jan Gryczynski (PI) has been awarded an R01 grant from the National Institute on Drug Abuse. The “Take-Home Expansion: Scope and Impact Study”, or THESIS, will examine the impact of recent changes in the delivery of methadone treatment. FRI Co-investigators include Drs. Robert Schwartz, Mishka Terplan, and Karli Hochstatter. Key collaborators on the project include RTI International (Drs. Tami Mark and Gary Zarkin) and BayMark Health Services (Dr. Nicholas Van Dyke). Methadone is an effective treatment for opioid use disorder (OUD) that is delivered in the U.S. through specialized Opioid Treatment Programs (OTPs). Since the inception of the OTP system many decades ago, federal regulations have required frequent clinic attendance to monitor patients’ response to treatment and reduce the risks of methadone diversion. Patients could only ‘earn’ take-home methadone after significant time in treatment while demonstrating rigid standards for adherence and stability. The COVID-19 pandemic transformed service delivery practices at OTPs. To reduce crowding in clinics, SAMHSA regulators swiftly issued regulatory exemptions that gave most OTPs unprecedented discretion to provide take-home methadone doses and deliver counseling via telehealth. OTPs were suddenly permitted to dispense up to 14 days of take-home methadone for ‘less stable’ patients, and 28 days for ‘stable’ patients. In late 2021, SAMHSA reaffirmed the regulatory exemptions and announced intentions to pursue permanent regulatory reform for OTPs. The THESIS project will examine the scope and impact of these major changes to care delivery, both in the immediate aftermath of the regulatory exemptions and prospectively. The study will use clinical and administrative data from BayMark Health Services, the largest provider of outpatient OUD treatment in the U.S. It could provide critical data to guide regulators, OTP administrators, and practitioners, yielding novel data that could inform methadone treatment delivery over the next decade and beyond.