Clinical trial NCT03464422: Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas
Official title: Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (ESTEEM-conneCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV in MSM
Keywords: HIV
MSM
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adaptation of the Effective Skills to Empower Effect Men (ESTEEM; Pachankis, 2014; Pachankis et al, 2015) intervention that addresses young gay and bisexual men's occurring maladaptive behavioral patterns, including HIV-transmission risk behavior and mental health concerns, to address multiple stigma-related stressors for young gay and bisexual men of color in a group therapy format. All participants were part of the same intervention (no randomization) to assess the feasibility and acceptability of this adapted intervention (protocol update 4.24.2019; please see attached protocol). Two cohorts were formed to retain ideal group size for group therapy (10-15 participants per group).
Primary purpose: PREVENTION

Brief summary: The purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas.

Detailed description: This study has two specific aims. Aim 1 will focus on the modification of an existing intervention manual (created by the study PI) using feedback from previous qualitative interviews with MSM in New Haven and Hartford, CT. Also incorporated will be recent qualitative research on MSM of color's resilience. Specifically, the ways in which racial minority stigma impacts the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in the face of these health threats.

Aim 2, will consist of the deliver of the adapted intervention to approximately 30 young MSM (15 HIV-negative and 15 HIV-positive) to gather data on the feasibility and acceptability of the newly adapted program. The evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement.

This project integrates expertise in culturally-sensitive evidence-based interventions for MSM's HIV risk into a community-based HIV prevention and care context at the Fair Haven Community Health Center, where the intervention will be delivered to the existing patient population.

As of April, 2019, the study protocol was updated and approved by the Yale IRB such that the two intervention cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process. Thus, there was no group assignment based on HIV serostatus.

Eligibility criteria: Inclusion Criteria:

Participants must:

* Report anticipated 6-month residential stability in New Haven county
* Self-identify as a gay or bisexual man or report being a man who has had past-12-month sex with a man
* Self-identify as an ethnic or racial minority, including Black, African American, Caribbean American, Hispanic, and Latinx
* Speak fluent English

Exclusion Criteria:

* Participants not meeting the inclusion criteria will not be eligible to participate.

Primary outcomes:
measure: Depression
timeFrame: 3 months
measure: HIV Transmission Risk
timeFrame: 90 days
Secondary outcomes:
measure: Overall Depression Severity and Impairment Scale
timeFrame: 3 months
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: 3 months
measure: Brief Symptom Inventory
timeFrame: 3 months
measure: Suicidal Ideation Attributes Scale
timeFrame: 3 months
measure: Alcohol Use Disorders Identification Test
timeFrame: 3 months
measure: Condom-use Self-Efficacy Questionnaire
timeFrame: 3 months
measure: Sexual Compulsivity Scale
timeFrame: 3 months
measure: Gay-Related Rejection Sensitivity Scale
timeFrame: 3 months
measure: Self-concealment Scale
timeFrame: 3 months
measure: Internalized Homophobia Scale
timeFrame: 3 months
Other outcomes:
measure: PrEP Use
timeFrame: 3 months
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: John Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
References: