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

Not Applicable

Recruiting

• Conditions: Discrimination, Social; Health Care Utilization
• Interventions: Behavioral: CBT Coping Intervention

• Registration Number: NCT04587869
• Lead Sponsor: RAND

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.

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 Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Study Start: 2021-02-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	CBT Coping 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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

APLA Health; 🇺🇸 Los Angeles, California, United States