Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men

NCT04587869 | Terminated Results

• 1 other identifier: R01MD014722
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of a randomized controlled trial of a multi-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Primary intervention objectives include increasing health care engagement and receipt of evidence-based preventive care, as well as better coping and reduced anticipated and internalized stigma, and medical mistrust among intervention participants.

Conditions

Discrimination, Social; Health Care Utilization

Keywords

Black/African American sexual minority men

Outcome Measures

Primary Outcomes (2)

• Inadequate Healthcare Utilization

  Indicator that the individual reported (1) fewer than 1 ambulatory visit AND (2) at least 1 emergency department visit (without subsequent hospitalization) or at least 1 hospitalization in the past 4 months at any of the 3 follow-up assessments (4, 8, and 12 months post-baseline)

  baseline to 12-month post-baseline

• Proportion of Evidence-based Care Components Received Across Follow-up Assessments

  For each individual, this measure is the number of components that were received at any time across the 3 follow-up assessments divided by the number of components they were eligible for at any time across the 3 follow-up assessments, expressed as a proportion. 25 components were evaluated and eligibility for each component varies by individual and follow-up period.

  baseline to 12 months post-baseline

Secondary Outcomes (1)

• Adaptive Coping Strategies (Social Support Seeking)

  4-, 8-, and 12-months post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

Behavioral: CBT Coping Intervention

No-treatment control

NO INTERVENTION

Participants who are assigned to the control group will not receive the intervention.

Interventions

CBT Coping Intervention BEHAVIORAL

A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologically male at birth; Identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Biologically male at birth
• Identify as male
• Self-identify as a Black/African American
• Report having sex with men in the past 24 months
• Anticipate being available for the next 12 months to attend study visits
• Able to interact and communicate in written and spoken English.

You may not qualify if:

• Unwilling/Unable to provide informed consent
• Cisgender women
• Transgender women
• Transgender men

Sponsors & Collaborators

• RAND: lead
• University of Massachusetts, Boston: collaborator
• University of Southern California: collaborator
• APLA Health: collaborator

Study Sites (1)

APLA Health

Los Angeles, California, 90016, United States

Location

MeSH Terms

Conditions

Social Discrimination; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Laura Bogart
• Organization: RAND

lbogart@rand.org

3103930411

Study Officials

• Laura Bogart, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor does not randomize participant until after the baseline assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 14, 2020
• Study Start: February 9, 2021
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: For three years, following publication of the main study papers.
• Access Criteria: Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Users must notify the institutional review board of their institution of their intention to use the data and their procedures for data management and security. Users must submit proposals regarding intended use of the data; the RAND study team and the RAND Human Subjects Protections Committee (HSPC) will determine the scientific soundness of the proposal as part of the decision for the researcher to be able to access the dataset.

Locations

US (1)