N/A N=254 Randomized Single-blind Prevention

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

HIV · Acquired Immunodeficiency Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02929069 ↗

Enrolled (actual)

254

Serious AEs

2.0%

Results posted

Jan 2022

Primary outcome: Primary: Any Condomless Anal Sex Acts — 43; 47; 17; 38 Participants — p=0.52

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ESTEEM (Behavioral); CMHT (Behavioral); VCT (Behavioral)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Yale University
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Any Condomless Anal Sex Acts	39; 26; 44; 41; 15; 36	—
SECONDARY Minority Stress: GRRS	10.01; 11.07; 10.53	—
SECONDARY Minority Stress: GRRS	10.01; 11.07; 10.53	—
SECONDARY Minority Stress: GRRS	10.01; 11.07; 10.53	—
SECONDARY Minority Stress: GRRS	10.01; 11.07; 10.53	—
SECONDARY Minority Stress: IHS	1.67; 1.38; 1.53	—
SECONDARY Minority Stress: IHS	1.67; 1.38; 1.53	—
SECONDARY Minority Stress: IHS	1.67; 1.38; 1.53	—
SECONDARY Minority Stress: IHS	1.67; 1.38; 1.53	—
SECONDARY Minority Stress: SOCS	1.87; 1.57; 1.83	—
SECONDARY Minority Stress: SOCS	1.87; 1.57; 1.83	—
SECONDARY Minority Stress: SOCS	1.87; 1.57; 1.83	—
SECONDARY Minority Stress: SOCS	1.87; 1.57; 1.83	—
SECONDARY Minority Stress: DERS	85.33; 86.73; 86.09	—
SECONDARY Minority Stress: DERS	85.33; 86.73; 86.09	—
SECONDARY Minority Stress: DERS	85.33; 86.73; 86.09	—
SECONDARY Minority Stress: DERS	85.33; 86.73; 86.09	—
SECONDARY Minority Stress: Brooding	11.55; 12.55; 12.09	—
SECONDARY Minority Stress: Brooding	11.55; 12.55; 12.09	—
SECONDARY Minority Stress: Brooding	11.55; 12.55; 12.09	—
SECONDARY Minority Stress: Brooding	11.55; 12.55; 12.09	—
SECONDARY Minority Stress: Rathus Assertiveness Schedule	103.26; 107.47; 108.61	—
SECONDARY Minority Stress: Rathus Assertiveness Schedule	103.26; 107.47; 108.61	—
SECONDARY Minority Stress: Rathus Assertiveness Schedule	103.26; 107.47; 108.61	—
SECONDARY Minority Stress: Rathus Assertiveness Schedule	103.26; 107.47; 108.61	—
SECONDARY Any Condomless Anal Sex Acts	39; 26; 44; 41; 15; 36	—
SECONDARY Any Condomless Anal Sex Acts	39; 26; 44; 41; 15; 36	—
SECONDARY Any Condomless Anal Sex Acts	39; 26; 44; 41; 15; 36	—
SECONDARY Safer Sex Self-Efficacy	44.68; 38.55; 41.53	—
SECONDARY Safer Sex Self-Efficacy	44.68; 38.55; 41.53	—
SECONDARY Safer Sex Self-Efficacy	44.68; 38.55; 41.53	—
SECONDARY Safer Sex Self-Efficacy	44.68; 38.55; 41.53	—
SECONDARY Decisional Balance	2.46; 2.71; 2.46; 3.17; 3.26; 3.0	—
SECONDARY Decisional Balance	2.46; 2.71; 2.46; 3.17; 3.26; 3.0	—
SECONDARY Decisional Balance	2.46; 2.71; 2.46; 3.17; 3.26; 3.0	—
SECONDARY Decisional Balance	2.46; 2.71; 2.46; 3.17; 3.26; 3.0	—
SECONDARY Depression: HAM-D	9.95; 11.49; 10.73	—
SECONDARY Depression: HAM-D	9.95; 11.49; 10.73	—
SECONDARY Depression: HAM-D	9.95; 11.49; 10.73	—
SECONDARY Depression: HAM-D	9.95; 11.49; 10.73	—
SECONDARY Depression: BSI GSI	0.65; 0.70; 0.76	—
SECONDARY Depression: BSI GSI	0.65; 0.70; 0.76	—
SECONDARY Depression: BSI GSI	0.65; 0.70; 0.76	—
SECONDARY Depression: BSI GSI	0.65; 0.70; 0.76	—
SECONDARY Substance Use: SIP-AD	2.51; 3.83; 2.79	—
SECONDARY Substance Use: SIP-AD	2.51; 3.83; 2.79	—
SECONDARY Substance Use: SIP-AD	2.51; 3.83; 2.79	—
SECONDARY Substance Use: SIP-AD	2.51; 3.83; 2.79	—
SECONDARY Any Pre-Exposure Prophylaxis (PrEP) Use	50; 22; 44; 11; 7; 20	—
SECONDARY Any Pre-Exposure Prophylaxis (PrEP) Use	50; 22; 44; 11; 7; 20	—
SECONDARY Any Pre-Exposure Prophylaxis (PrEP) Use	50; 22; 44; 11; 7; 20	—
SECONDARY Any Pre-Exposure Prophylaxis (PrEP) Use	50; 22; 44; 11; 7; 20	—

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02929069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.