A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Yale University
- Enrollment
- 254
- Locations
- 2
- Primary Endpoint
- Any Condomless Anal Sex Acts
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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).
Outcomes
Primary Outcomes
Any Condomless Anal Sex Acts
Time Frame: 8 Months
Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Secondary Outcomes
- Minority Stress: GRRS(12 Months)
- Minority Stress: IHS(12 Months)
- Depression: HAM-D(12 Months)
- Minority Stress: Rathus Assertiveness Schedule(12 Months)
- Any Pre-Exposure Prophylaxis (PrEP) Use(12 Months)
- Minority Stress: SOCS(12 Months)
- Safer Sex Self-Efficacy(12 Months)
- Decisional Balance(12 Months)
- Minority Stress: DERS(12 Months)
- Minority Stress: Brooding(12 Months)
- Substance Use: SIP-AD(12 Months)
- Any Condomless Anal Sex Acts(12 Months)
- Depression: BSI GSI(12 Months)