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

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.

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

Primary outcomes

• Inadequate Healthcare Utilization [baseline to 12-month post-baseline]: 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)
• Proportion of Evidence-based Care Components Received Across Follow-up Assessments [baseline to 12 months post-baseline]: 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.

Secondary outcomes

• Adaptive Coping Strategies (Social Support Seeking) [4-, 8-, and 12-months post-baseline]: Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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 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

Participant flow

Outcome results

• Inadequate Healthcare Utilization (Primary), Count of participants, Participants: Intervention 41; No-treatment Control 39 (p .44)
• Proportion of Evidence-based Care Components Received Across Follow-up Assessments (Primary), Mean, proportion: Intervention .46 +/- .22; No-treatment Control .47 +/- .23 (p .47)
• Adaptive Coping Strategies (Social Support Seeking) (Secondary), Mean, units on a scale (range 1-4): Intervention 2.60 +/- 0.96; No-treatment Control 2.50 +/- 0.96 (p .02)

Adverse events

Time frame: 1 year

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-01-13)
• Informed Consent Form (PDF, 2023-04-04)

• Laura Bogart, PhD, Principal investigator, RAND