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

Still Climbin': A Randomized Controlled Trial to Improve Coping, Medical Mistrust, and Healthcare Engagement Among Black Sexual Minority Men

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.

Study Overview

• Status: Recruiting
• Conditions: Health Care Utilization; Discrimination, Social
• Intervention / Treatment: Behavioral: CBT Coping Intervention

Detailed Description

This study is a randomized controlled trial of Still Climbin', an 8-session cognitive behavior therapy (CBT) group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). Designed to be flexible for use in community settings, this intervention was developed in partnership with community stakeholders who emphasized the need for a community-based program outside of the health care system, and without a specific disease focus. It intends to give Black SMM a safe space to receive support for the whole of their identity and to openly discuss barriers to health care. Participants will be followed for 12 months. The effectiveness of the Still Climbin' intervention will be assessed on health care engagement and receipt of evidence-based preventive care, through surveys administered at multiple points throughout the intervention period. These outcomes will be confirmed with information from medical records. A total of 370 Black participants will be recruited and randomly assign 185 to receive the coping intervention and 185 to a no-treatment control. There will be about 10 groups of about 15 participants each for both intervention and control. Participants will be randomized to an intervention or control group after they complete the baseline survey. Participants will complete four surveys, starting with the baseline survey, and followed by 4-, 8-, and 12-month post-baseline follow-up surveys to assess health care engagement and receipt of evidence-based preventive care (e.g., cancer and diabetes screening, cardiovascular disease prevention, influenza vaccination, HIV prevention), and other topics such as coping strategies, stigma, and discrimination. The intervention is hypothesized to show increased health care engagement and receipt of evidence-based preventive care, in addition to better coping and reduced medical mistrust than the control group.

• Study Type: Interventional
• Enrollment (Estimated): 370
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Bogart, PhD; Phone Number: 7281 (310) 393-0411; Email: lbogart@rand.org
• Study Contact Backup: Name: Terry Marsh, MPH; Phone Number: 6846 (310) 393-0411; Email: tmarsh@rand.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90016
      • Recruiting
      • APLA Health
      • Contact: Matt G Mutchler, PhD; Email: mmutchler@csudh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 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 in Los Angeles County and available for the next 12 months to attend study visits
• Able to interact and communicate in written and spoken English.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).
No Intervention: No-treatment control; Participants who are assigned to the control group will not receive the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced proportion of participants who have inadequate healthcare utilization	Participants report (1) fewer than 1 ambulatory visit, (2) at least 1 emergency department visit (without subsequent hospitalization), or (3) at least 1 hospitalization	12-month pre-baseline to 12-month post-baseline
Increased proportion of participants receiving evidence-based care across conditions	Receipt of screening and prevention for chronic diseases (e.g., cancer, cardiovascular disease, diabetes), and receipt of recommended immunizations (e.g., influenza)	12 months pre-baseline to 12 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adaptive coping strategies	Average adaptive coping rating on the Brief COPE scale (higher=better coping; range=1-4)	Baseline to 4-, 8-, and 12-months

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: University of Southern California; University of Massachusetts, Boston; APLA Health
• Investigators: Principal Investigator: Laura Bogart, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Black/African American sexual minority men
• Other Study ID Numbers: R01MD014722 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following publication of the main study papers, de-identified survey data will be made publicly available to researchers who successfully complete a registration process after requesting to use the data. The data made available will not contain any direct or indirect identifiers. 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.
• IPD Sharing Time Frame: For three years, following publication of the main study papers.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No