Clinical trial NCT02929069: A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Official title: A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Acquired Immunodeficiency Syndrome
Keywords: Minority Stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-10-10
Enrollment: 254
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Any Condomless Anal Sex Acts
timeFrame: 8 Months
Secondary outcomes:
measure: Minority Stress: GRRS
timeFrame: Baseline
measure: Minority Stress: GRRS
timeFrame: 4 Months
measure: Minority Stress: GRRS
timeFrame: 8 Months
measure: Minority Stress: GRRS
timeFrame: 12 Months
measure: Minority Stress: IHS
timeFrame: Baseline
measure: Minority Stress: IHS
timeFrame: 4 Months
measure: Minority Stress: IHS
timeFrame: 8 Months
measure: Minority Stress: IHS
timeFrame: 12 Months
measure: Minority Stress: SOCS
timeFrame: Baseline
measure: Minority Stress: SOCS
timeFrame: 4 Months
measure: Minority Stress: SOCS
timeFrame: 8 Months
measure: Minority Stress: SOCS
timeFrame: 12 Months
measure: Minority Stress: DERS
timeFrame: Baseline
measure: Minority Stress: DERS
timeFrame: 4 Months
measure: Minority Stress: DERS
timeFrame: 8 Months
measure: Minority Stress: DERS
timeFrame: 12 Months
measure: Minority Stress: Brooding
timeFrame: Baseline
measure: Minority Stress: Brooding
timeFrame: 4 Months
measure: Minority Stress: Brooding
timeFrame: 8 Months
measure: Minority Stress: Brooding
timeFrame: 12 Months
measure: Minority Stress: Rathus Assertiveness Schedule
timeFrame: Baseline
measure: Minority Stress: Rathus Assertiveness Schedule
timeFrame: 4 Months
measure: Minority Stress: Rathus Assertiveness Schedule
timeFrame: 8 Months
measure: Minority Stress: Rathus Assertiveness Schedule
timeFrame: 12 Months
measure: Any Condomless Anal Sex Acts
timeFrame: Baseline
measure: Any Condomless Anal Sex Acts
timeFrame: 4 Months
measure: Any Condomless Anal Sex Acts
timeFrame: 12 Months
measure: Safer Sex Self-Efficacy
timeFrame: Baseline
measure: Safer Sex Self-Efficacy
timeFrame: 4 Months
measure: Safer Sex Self-Efficacy
timeFrame: 8 Months
measure: Safer Sex Self-Efficacy
timeFrame: 12 Months
measure: Decisional Balance
timeFrame: Baseline
measure: Decisional Balance
timeFrame: 4 Months
measure: Decisional Balance
timeFrame: 8 Months
measure: Decisional Balance
timeFrame: 12 Months
measure: Depression: HAM-D
timeFrame: Baseline
measure: Depression: HAM-D
timeFrame: 4 Months
measure: Depression: HAM-D
timeFrame: 8 Months
measure: Depression: HAM-D
timeFrame: 12 Months
measure: Depression: BSI GSI
timeFrame: Baseline
measure: Depression: BSI GSI
timeFrame: 4 Months
measure: Depression: BSI GSI
timeFrame: 8 Months
measure: Depression: BSI GSI
timeFrame: 12 Months
measure: Substance Use: SIP-AD
timeFrame: Baseline
measure: Substance Use: SIP-AD
timeFrame: 4 months
measure: Substance Use: SIP-AD
timeFrame: 8 Months
measure: Substance Use: SIP-AD
timeFrame: 12 Months
measure: Any Pre-Exposure Prophylaxis (PrEP) Use
timeFrame: Baseline
measure: Any Pre-Exposure Prophylaxis (PrEP) Use
timeFrame: 4 Months
measure: Any Pre-Exposure Prophylaxis (PrEP) Use
timeFrame: 8 Months
measure: Any Pre-Exposure Prophylaxis (PrEP) Use
timeFrame: 12 Months
Other outcomes:
measure: HIV Test
timeFrame: Baseline
measure: HIV Test
timeFrame: 12 Months
measure: Gonorrhea Test
timeFrame: Baseline
measure: Gonorrhea Test
timeFrame: 12 Months
measure: Chlamydia Test
timeFrame: Baseline
measure: Chlamydia Test
timeFrame: 12 Months
Locations:
city: New Haven
country: United States
facility: School of Public Health, Yale University
state: Connecticut
city: Miami
country: United States
facility: Clinical Research Building, University of Miami
state: Florida
Study officials:
affiliation: MYSM School Of Medicine
name: John Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pachankis JE, McConocha EM, Reynolds JS, Winston R, Adeyinka O, Harkness A, Burton CL, Behari K, Sullivan TJ, Eldahan AI, Esserman DA, Hatzenbuehler ML, Safren SA. Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health. BMC Public Health. 2019 Aug 9;19(1):1086. doi: 10.1186/s12889-019-7346-4.