Background/Overview: This project involves various research studies as well as mentoring junior investigators in behavioral interventions related to HIV treatment and prevention, specifically focusing on associated psychosocial syndemics relevant to HIV prevention and care. Mental health problems, including substance abuse, are of the most frequent comorbidities to HIV and are consistently identified as barriers to adherence, engagement in care, and reductions in risk behavior. Typically, these problems co-occur as "syndemics" (co-occurring psychosocial problems that interact with each other and with HIV risk). Studies have found exceptionally high levels of comorbidity in patients with HIV and depression. This has raised the need to address other syndemics (e.g. substance abuse, PTSD, other anxiety disorders) in addition to depression in the context of care. Studies for this project include 1) using cognitive behavioral therapy to address syndemics in the context of HIV care in patients with uncontrolled virus, 2) analyses of cohort data on syndemics in individuals living with HIV care who are in treatment, and 3) qualitative data to examine the impact of syndemics on HIV transmission risk and adherence in individuals living with HIV in care. Current study open for enrollment: If you are interested in participating in this study, please visit this link to see if you preliminarily qualify.
Background/Overview: ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men’s (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM’s health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. The Unified Protocol changes underlying stress pathways using motivational interviewing, emotional and situational exposure, cognitive restructuring, mindfulness, and self-monitoring exercises.
The first aim is to test the efficacy of ESTEEM against (1) community mental health treatment (CMHT) and (2) HIV voluntary counseling and testing (VCT). Our primary outcome is condomless anal sex in the absence of either PrEP or known undetectable viral load of HIV+ primary partners. Knowing whether ESTEEM yields greater improvement than time-matched CMHT will establish the benefit of our transdiagnostic approach. Comparing ESTEEM to VCT offers a strong test of ESTEEM’s incremental cost-effectiveness. The second aim is to determine whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. 3-, 6-, and 12-month follow-ups will determine if improvements in minority stress processes precede and statistically mediate outcome improvements. Mediation will validate the minority stress theory of ESTEEM and provide transdiagnostic targets for future YGBM health interventions. The third aim is to estimate ESTEEM’s incremental cost-effectiveness compared to VCT in terms of HIV infections averted and improved mental health. ESTEEM shows preliminary efficacy for improving the full spectrum of YGBM health. We will collect resource use and cost data to estimate return on investment of this transdiagnostic health approach compared to standard single outcome/stand-alone treatment approaches. The overall study PI is Dr. John Pachankis of Yale University School of Public Health.
The first aim is to compare Project IMPACT intervention efficacy to a (1) time and intensity matched control and a (2) Standard of Care arm. Our primary outcome is the number of condomless anal sex (CAS) acts with men without PrEP at baseline, four-, eight-, and 12-month. Our secondary outcome is the reductions in number of stimulant use episodes at baseline, four-, eight-, and 12-month. The second aim is to examine the degree to which: a) Reductions in sexual risk are mediated by reductions in stimulant use; b) Conceptual mediators, including increases in information, motivation, behavioral skills, and decreases in depressed mood, and decreases in polydrug use, are associated with increases in pleasurable (but safe) activities by; and c) Reductions in sexual risk are associated with epidemiologically-identified moderators of sexual risk and stimulant use: age, race/ethnicity, and psychosocial factors. 4-, 8-, and 12-month follow up visits will determine if improvements in stimulant use precede and statistically mediate outcome improvements The third aim is to estimate the cost-effectiveness of the Project IMPACT intervention. Assessing the cost-effectiveness of this behavioral intervention will include evaluating the feasibility of scale-up and replicability in future efficacy trials. Project IMPACT is a Multiple Principal Investigator (MPI) study between Dr. Matthew Mimiaga at Brown University in Providence, RI and Dr. Steven Safren at the University of Miami in Miami, FL.