Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas

NCT ID: NCT03464422

Last Updated: 2021-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-09

Study Completion Date

2019-08-01

Brief Summary

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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

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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.

Conditions

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HIV in MSM

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Young gay and bisexual men of color

Approximately 30 young MSM of color will take part in weekly 90-minute group treatment sessions over 10 weeks. All participants will complete outcome assessments at baseline and three months post-treatment, as well as an exit interview.

Group Type EXPERIMENTAL

ESTEEM conneCT

Intervention Type BEHAVIORAL

The intervention adapts the ESTEEM (Pachankis et al, 2015) intervention to address the multiple-stigma stressors faced by MSM of color, including sexual orientation and racial stigma in a manualized, CBT-based intervention. Approximately thirty participants (divided between two cohorts) will complete ten group sessions will take place at regular times once per week over the course of three months. The groups will be "closed," in that no new members will be allowed to join after the first week in order to promote open self-disclosure and trust among group members.

Interventions

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ESTEEM conneCT

The intervention adapts the ESTEEM (Pachankis et al, 2015) intervention to address the multiple-stigma stressors faced by MSM of color, including sexual orientation and racial stigma in a manualized, CBT-based intervention. Approximately thirty participants (divided between two cohorts) will complete ten group sessions will take place at regular times once per week over the course of three months. The groups will be "closed," in that no new members will be allowed to join after the first week in order to promote open self-disclosure and trust among group members.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Pachankis, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P30MH062294-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000022422

Identifier Type: -

Identifier Source: org_study_id

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