Discrimination, Social, Health Care Utilization
Conditions
Keywords
Black/African American sexual minority men
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.
Interventions
BEHAVIORALCBT Coping Intervention
A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).
Sponsors
University of Massachusetts, Boston
University of Southern California
APLA Health
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor does not randomize participant until after the baseline assessment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
CBT Coping Intervention: A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM). | 171 |
| No-treatment Control Participants who are assigned to the control group will not receive the intervention. | 198 |
| Total | 369 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Grant Termination | 13 | 25 |
| Overall Study | Lost to Follow-up | 27 | 34 |
| Overall Study | Other | 1 | 0 |
| Overall Study | too busy | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | No-treatment Control | Intervention |
|---|---|---|---|
| Adaptive coping (social support seeking) | 2.61 units on a 4-point scale (range 1-4) STANDARD_DEVIATION 0.92 | 2.57 units on a 4-point scale (range 1-4) STANDARD_DEVIATION 0.92 | 2.65 units on a 4-point scale (range 1-4) STANDARD_DEVIATION 0.91 |
| Age, Continuous | 44.73 years STANDARD_DEVIATION 12.78 | 44.73 years STANDARD_DEVIATION 12.37 | 44.73 years STANDARD_DEVIATION 13.27 |
| Inadequate healthcare utilization | 88 Participants | 53 Participants | 35 Participants |
| Proportion of evidence-based care components received | 0.60 proportion STANDARD_DEVIATION 0.22 | 0.60 proportion STANDARD_DEVIATION 0.22 | 0.59 proportion STANDARD_DEVIATION 0.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 356 Participants | 190 Participants | 166 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 369 participants | 198 participants | 171 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 369 Participants | 198 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 171 | 0 / 198 |
| other Total, other adverse events | 0 / 171 | 0 / 198 |
| serious Total, serious adverse events | 22 / 171 | 17 / 198 |
Outcome results
Primary
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)
Time frame: baseline to 12-month post-baseline
Population: The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Inadequate Healthcare Utilization | 41 Participants |
| No-treatment Control | Inadequate Healthcare Utilization | 39 Participants |
Comparison: Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.p-value: 0.4495% CI: [0.73, 2.07]Regression, Logistic
Primary
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.
Time frame: baseline to 12 months post-baseline
Population: The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys (nonresponse weights were used to account for potential bias). The outcome was never missing among those who participated in any follow-up surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Proportion of Evidence-based Care Components Received Across Follow-up Assessments | .46 proportion | Standard Deviation 0.22 |
| No-treatment Control | Proportion of Evidence-based Care Components Received Across Follow-up Assessments | .47 proportion | Standard Deviation 0.23 |
Comparison: Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.p-value: 0.47Regression, Linear
Secondary
Adaptive Coping Strategies (Social Support Seeking)
Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)
Time frame: 4-, 8-, and 12-months post-baseline
Population: The outcome is missing for all participants (n=53) who did not participate in any follow-up surveys. The outcome is missing for an additional n=10 (3.2%) participants who did not complete any of the 4 survey items included in the scale.~Because this measure was analyzed in a repeated measures regression framework where each participant may contribute up to 3 observations (and may or may not complete each assessment), the sample size varies by assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Adaptive Coping Strategies (Social Support Seeking) | 4-month assessment | 2.60 units on a scale (range 1-4) | Standard Deviation 0.96 |
| Intervention | Adaptive Coping Strategies (Social Support Seeking) | 8-month assessment | 2.77 units on a scale (range 1-4) | Standard Deviation 0.96 |
| Intervention | Adaptive Coping Strategies (Social Support Seeking) | 12-month assessment | 2.61 units on a scale (range 1-4) | Standard Deviation 0.92 |
| No-treatment Control | Adaptive Coping Strategies (Social Support Seeking) | 4-month assessment | 2.50 units on a scale (range 1-4) | Standard Deviation 0.96 |
| No-treatment Control | Adaptive Coping Strategies (Social Support Seeking) | 8-month assessment | 2.56 units on a scale (range 1-4) | Standard Deviation 0.92 |
| No-treatment Control | Adaptive Coping Strategies (Social Support Seeking) | 12-month assessment | 2.41 units on a scale (range 1-4) | Standard Deviation 0.91 |
Comparison: Unlike the two primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant. In addition, nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.p-value: 0.02Regression, Linear