Sexual minority men (SMM), including gay and bisexual men, face a disproportionate burden of HIV, accounting for most new U.S. infections despite being a small population. Treatment as Prevention (TasP), which promotes early antiretroviral therapy (ART) to suppress viral load (VL), is highly effective in reducing transmission. However, disparities in timely care, ART adherence, and VL suppression persist among SMM. Our research and interventions aim to reduce these disparities.
These NIH R01 studies are currently in the field. For a full list of publications, please visit here.
START. The NIDA-funded study entitled “Supporting Treatment Adherence for Resilience and Thriving (START): A mHealth intervention to improve ART adherence for HIV-positive stimulant-using men” (Hirshfield, Co-PI) is currently in the field, collecting data to test the efficacy of START, which is a national mHealth intervention integrating two theoretically grounded, evidence-based behavioral interventions.
For this two-arm randomized controlled trial, we have recruited and are following 285 participants for 12 months. The primary outcome to be measured is 6-month HIV viral load suppression at 6 months and determine whether any gains are maintained at month 12.
The interventions cover mindfulness and HIV medication adherence. The goal of START is to reach sexual minority men (SMM) with HIV and stimulant use dependence, both inside and outside of major urban centers, to develop a scalable, efficacious, mHealth approach to optimize adherence to antiretroviral medications, regardless of whether men are seeking formal substance use treatment. Participants randomized to the intervention app can access tools to encourage medication adherence, activities to improve mood, and information related to health. Participants randomized to the control will receive access to a static, online national resource site with links to HIV care services.
If effective, START is scalable to reach a broader population of people with HIV and stimulant use dependence. The START app may be adapted to clinic- and community-based settings. [PIs: Drs. Adam Carrico at Florida International University, Sabina Hirshfield at SUNY Downstate, and Keith Horvath at San Diego State University]
Ur Heart. A START sub-study, called UrHeart, is a NIDA-funded study to test the feasibility and acceptability of collecting home urine specimens for lab-based testing of drugs and heart health. Among 25 START participants we will test a 2-timepoint model of home urine collection to check for stimulants adulterated with fentanyl analogs and to check for the presence of troponin, which signals cardiac injury that may be related to stimulant use. At baseline and 3-month follow-up, participants will mail urine specimens to a forensic toxicology lab, which will test for the presence of 50 or more substances, including synthetic fentanyl and cocaine.
Participants will complete an online survey at baseline and three months, receive their test results, and complete post-test surveys. They can schedule a time to speak with study staff about what their results mean and can participate in a qualitative interview about their study experiences.
We will determine whether conducting remote urine collection can impact subsequent drug use and healthcare utilization behaviors. We will analyze longitudinal drug use patterns, assess the prevalence of unintentional fentanyl exposure, and compare self-reported vs. lab-tested drug use data. [PIs: Drs. Adam Carrico at Florida International University, Sabina Hirshfield at SUNY Downstate, and Keith Horvath at San Diego State University]
THRIVE 3. This NINR-funded study, Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life among Rural Older Adults Living with HIV (THRIVE 3), aims to improve VL suppression, ART adherence, and health-related quality of life (HRQOL) among rural older people with HIV, a population facing unique health disparities, social isolation, and structural barriers to care. Building on formative research and a successful pilot study, we will conduct a full-scale efficacy trial using a 2×2 factorial design to evaluate two scalable, remotely delivered interventions: supportive-expressive peer social support groups and strengths-based case management (SBCM). A total of 352 rural older PLH from the Southern U.S., including priority states in the Ending the HIV Epidemic (EtHE) plan, will be enrolled and assessed at baseline, 4, 8, and 12 months, utilizing dried blood spot (DBS) technology for remote VL measurement. Aim 1 will assess the impact of these interventions on VL suppression, ART adherence, and HRQOL, with exploratory analyses examining moderation by demographic factors. Aim 2 will evaluate secondary outcomes, including reductions in depressive symptoms, HIV stigma, and structural barriers to care, as well as increases in social support, self-efficacy, and service utilization. Findings will provide critical evidence to support scalable interventions that enhance HIV care engagement and health equity in rural settings, contributing to national efforts to end the HIV epidemic. [PIs: Drs. Jennifer Walsh and Andrew Petroll at the Medical College of Wisconsin. Dr. Hirshfield is a Co-I.]
UniquelyU. This NIAID-funded study, called Understanding Viral Suppression for Newly Diagnosed HIV+ Men to Inform implementation of TasP/U=U (UniquelyU), is enrolling up to 250 newly diagnosed sexual minority men. and follow them for two years to understand factors associated with viral suppression, using monthly dried blood spot testing. We propose a two-phase study to investigate factors influencing viral suppression and barriers to implementing Undetectable = Untransmittable (U=U) among sexual minority men (SMM). In Study 1, we will leverage nationwide LITE cohorts to follow 250 newly seroconverted SMM living with HIV (SMM-LHIV) for 24 months post-diagnosis, collecting monthly dried blood spots (DBS) for viral load (VL) quantification, quarterly ART adherence and care engagement data, semiannual psychosocial and behavioral surveys, annual structural barrier indices, and qualitative interviews with 30% of participants. In Study 2, we will conduct virtual and in-person focus groups with SMM-LHIV, HIV-negative SMM, and HIV care providers to assess barriers to U=U implementation. Our aims are to (1) identify structural, psychosocial, and behavioral factors influencing VL suppression, (2) examine adherence, perceived versus objective VL status, and sexual risk compensation to assess TasP safety, and (3) characterize stakeholder concerns over time to inform strategies for scaling up TasP and U=U adoption. [PIs: Drs. Ali Talan and Jonathon Rendina at Whitman Walker. Dr. Hirshfield is a Co-I.]
