A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk

The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.

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. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.

Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.

Eligibility Criteria:
Inclusion Criteria:

* self-identification as a gay, bisexual or queer man;
* HIV-negative status confirmed through in-office testing;
* diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder;
* risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP);
* not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week);
* NYC or Miami residential stability and planned availability for 12 months;
* English-language proficiency; and (9) provision of informed consent.

Exclusion Criteria:

* current active suicidality or homicidality (but not passive suicidality);
* evidence of active untreated mania, psychosis, or gross cognitive impairment;
* current enrollment in another intervention study;
* currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year;
* HIV-positive status (confirmed through in-office testing).