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Clinical Trials/NCT03464422
NCT03464422CompletedNot Applicable

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

Yale University1 site in 1 country21 target enrollmentStarted: September 9, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Depression

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Young gay and bisexual men of color

Experimental

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.

Intervention: ESTEEM conneCT (Behavioral)

Outcomes

Primary Outcomes

Depression

Time Frame: 3 months

To measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60.

HIV Transmission Risk

Time Frame: 90 days

Risk of HIV transmission was assessed through the Past-90-day Timeline Follow-back interview (TLFB; Sobell \& Sobell, 1992). HIV risk behavior was calculated as the number of past-90-day sex acts in which key harm-reduction strategies were not employed (e.g., condom, PrEP, viral load suppression) and calculated by dividing the total number of sex acts at risk for HIV transmission by the total number of sex acts. Sex acts range from 0 to (theoretically) infinite.

Secondary Outcomes

  • Overall Depression Severity and Impairment Scale(3 months)
  • Overall Anxiety Severity and Impairment Scale(3 months)
  • Brief Symptom Inventory(3 months)
  • Condom-use Self-Efficacy Questionnaire(3 months)
  • Suicidal Ideation Attributes Scale(3 months)
  • Gay-Related Rejection Sensitivity Scale(3 months)
  • Self-concealment Scale(3 months)
  • Alcohol Use Disorders Identification Test(3 months)
  • Internalized Homophobia Scale(3 months)
  • Sexual Compulsivity Scale(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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