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

Yale University

Status: Completed

Conditions: HIV; Acquired Immunodeficiency Syndrome

Treatments: Behavioral: ESTEEM; Behavioral: VCT; Behavioral: CMHT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02929069

1R01MH109413-01 (U.S. NIH Grant/Contract)

1509016430

Details and patient eligibility

About

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.

Full 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.

Enrollment: 254 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 3 patient groups

ESTEEM

Experimental group

Description:

Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.

Treatment:

Behavioral: VCT

Behavioral: ESTEEM

Community Mental Health Treatment (CMHT)

Active Comparator group

Description:

Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.

Treatment:

Behavioral: VCT

Behavioral: CMHT

Voluntary Counselling and Testing (VCT)

Active Comparator group

Description:

Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.

Treatment:

Behavioral: VCT