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

Health Care Utilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04587869
• Other study ID #: R01MD014722
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: RAND
• Contact: Laura Bogart, PhD
• Phone: (310) 393-0411
• Email: lbogart[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discrimination, Social
• Health Care Utilization

Intervention

Behavioral:
• CBT Coping Intervention
A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).

Locations

Country	Name	City	State
United States	APLA Health	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
RAND	APLA Health, University of Massachusetts, Boston, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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