Cathy Reback

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, “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.

Friends Community Center Receives Grant

FRI’s community research site, Friends Community Center located in Hollywood, CA, was recently awarded the “Opioid Use and Stimulant Use Education and Outreach in 2S/LGBTQ+ Communities” grant funded by The Center at Sierra Health Foundation. Funding is awarded to organizations throughout California that are focused on expanding prevention and recovery services for people with substance use disorder.

In its second year of funding, The Spencer Project, will focus on implementing a holistic continuum of harm reduction and care services, specifically related to opioid and stimulant use, designed to benefit 2S/LGBTQ+ populations in the Hollywood/West Hollywood area of Los Angeles County. Using a two-pronged approach, The Spencer Project will combine harm reduction education through outreach to the community and a personalized treatment navigation plan for individuals identified as seeking treatment for opioid or stimulant use.

Friends Community Center Receives Grant

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.

Dr. Shannon Gwin Mitchell Receives R01 Award

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.

Dr. Karli Hochstatter Receives First R01 Award

Dr. Karli Hochstatter of Friends Research Institute (FRI) has been awarded an R01 grant from the National Institute on Drug Abuse/National Institutes of Health HEAL Initiative, entitled “Identifying Suspected Drug Overdose Deaths in Near Real-Time Using Data Collected by Death Investigators.” Along with Dr. Hochstatter, the interdisciplinary team of experts include Co-Investigators Dr. Jan Gryczynski of FRI and Drs. Nabila El-Bassel and Smaranda Muresan from Columbia University. This study aims to improve monitoring of overdose fatalities and overcome barriers associated with significantly delayed death certificate data for suspected drug-related deaths. In close collaboration with the New York City (NYC) Office of Chief Medical Examiner (OCME), this study will comprehensively evaluate and refine a tool, named the Suspected Potential Overdose Tracker (SPOT), that uses data routinely collected during death investigations to identify accidental drug overdose as the cause and manner of death in near real-time. While preliminary findings show that SPOT is highly promising for identifying fatal overdoses in near real-time, there is a need to further enhance the tool, examine its performance across different subpopulations, and assess its performance and usability outside of NYC. Thus, this study aims to (1) Optimize SPOT through additional data from the NYC OCME to improve performance of the tool and develop advanced features using natural language processing; (2) Assess barriers and facilitators of adopting SPOT in preparation for its deployment through semi structured interviews with users of overdose mortality data; and (3) Evaluate the usability and performance of SPOT in coroner/medical examiner offices across New York State, including counties involved in the NIDA-funded HEALing Communities Study. The public health implications of adopting this tool are significant, as near real-time data on overdose deaths will allow for rapid data-driven decision making, the identification of gaps in public health and public safety overdose response preparedness, and opportunities to evaluate overdose prevention interventions, programs, and policies. If found successful, the SPOT methodology can be readily disseminated to other states to enhance surveillance of drug overdose mortality.


Jan Gryczynski, Ph.D.

Dr. Jan Gryczynski Receives R01 Award

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.


Michael S. Gordon

Drs. Michael Gordon and Thomas Blue Receive R34 Award

FRI is pleased to announce that Drs. Michael S Gordon (MPI) and Thomas R. Blue (Co-I), along with Dr. Curt Beckwith (MPI) from The Miriam Hospital/Rhode Island Hospital and Alpert Medical School of Brown University and Dr. Lauren Brinkley-Rubinstein (MPI), from the Social Medicine at UNC—Chapel Hill have received a three-year R34 grant from the National Institute on Drug Abuse entitled, Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community. The study will be conducted in in collaboration with the Maryland Department of Public Safety and Correctional Services (MD DPSCS) and Total Health Care.

The study has three specific aims. Aim 1: Conduct interviews with justice and treatment experienced persons living with HIV (PWH) (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral anti-retroviral therapy (ART) to long-acting injectable ART in prison with continuation during community re-entry. Aim 2: Develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 10 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to evaluate study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period. Aim 3: Following optimization of the LAI ART community re-entry protocol, conduct a pilot RCT among 50 incarcerated PWH eligible for LAI ART and scheduled to be released from prison; participants will be randomized 1:1 to transition cabotegravir (CAB), the first FDA-approved LAI ART regimen, or continue their daily oral ART regimen through a six-month follow-up period after release. During the follow-up period, we will assess the primary outcome of HIV viral suppression and secondary outcomes including ART adherence, substance use, and continuance of the assigned LAI or oral ART regimen.