Trial Outcomes & Findings for Still Climbin': An Intervention to Improve Coping Among Black Sexual Minority Men (NCT NCT04587869)
NCT ID: NCT04587869
Last Updated: 2025-11-13
Results Overview
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)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
369 participants
Primary outcome timeframe
baseline to 12-month post-baseline
Results posted on
2025-11-13
Participant Flow
Participant milestones
| Measure |
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).
|
No-treatment Control
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
198
|
|
Overall Study
COMPLETED
|
125
|
137
|
|
Overall Study
NOT COMPLETED
|
46
|
61
|
Reasons for withdrawal
| Measure |
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).
|
No-treatment Control
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
27
|
34
|
|
Overall Study
Grant Termination
|
13
|
25
|
|
Overall Study
too busy
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits
Baseline characteristics by cohort
| Measure |
Intervention
n=171 Participants
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).
|
No-treatment Control
n=198 Participants
Participants who are assigned to the control group will not receive the intervention.
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.73 years
STANDARD_DEVIATION 13.27 • n=171 Participants
|
44.73 years
STANDARD_DEVIATION 12.37 • n=198 Participants
|
44.73 years
STANDARD_DEVIATION 12.78 • n=369 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=171 Participants
|
198 Participants
n=198 Participants
|
369 Participants
n=369 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Race (NIH/OMB)
Black or African American
|
166 Participants
n=171 Participants
|
190 Participants
n=198 Participants
|
356 Participants
n=369 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=171 Participants
|
8 Participants
n=198 Participants
|
13 Participants
n=369 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=198 Participants
|
0 Participants
n=369 Participants
|
|
Region of Enrollment
United States
|
171 participants
n=171 Participants
|
198 participants
n=198 Participants
|
369 participants
n=369 Participants
|
|
Inadequate healthcare utilization
|
35 Participants
n=167 Participants • This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits
|
53 Participants
n=197 Participants • This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits
|
88 Participants
n=364 Participants • This outcome was missing for 5 participants (1.4%) who did not respond to at least one of 3 items asking about hospital visits, ER visits, and urgent care visits
|
|
Proportion of evidence-based care components received
|
0.59 proportion
STANDARD_DEVIATION 0.22 • n=171 Participants
|
0.60 proportion
STANDARD_DEVIATION 0.22 • n=198 Participants
|
0.60 proportion
STANDARD_DEVIATION 0.22 • n=369 Participants
|
|
Adaptive coping (social support seeking)
|
2.65 units on a 4-point scale (range 1-4)
STANDARD_DEVIATION 0.91 • n=171 Participants • This outcome was missing for n=4 (1.1%), participants who did not respond to any of the 4 survey items included in this scale
|
2.57 units on a 4-point scale (range 1-4)
STANDARD_DEVIATION 0.92 • n=194 Participants • This outcome was missing for n=4 (1.1%), participants who did not respond to any of the 4 survey items included in this scale
|
2.61 units on a 4-point scale (range 1-4)
STANDARD_DEVIATION 0.92 • n=365 Participants • This outcome was missing for n=4 (1.1%), participants who did not respond to any of the 4 survey items included in this scale
|
PRIMARY outcome
Timeframe: baseline to 12-month post-baselinePopulation: 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.
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)
Outcome measures
| Measure |
Intervention
n=148 Participants
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).
|
No-treatment Control
n=168 Participants
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Inadequate Healthcare Utilization
|
41 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 months post-baselinePopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=148 Participants
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).
|
No-treatment Control
n=168 Participants
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Proportion of Evidence-based Care Components Received Across Follow-up Assessments
|
.46 proportion
Standard Deviation .22
|
.47 proportion
Standard Deviation .23
|
SECONDARY outcome
Timeframe: 4-, 8-, and 12-months post-baselinePopulation: 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.
Average adaptive coping rating on the Brief COPE scale, social support items (higher=better coping; range=1-4)
Outcome measures
| Measure |
Intervention
n=143 Participants
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).
|
No-treatment Control
n=163 Participants
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Adaptive Coping Strategies (Social Support Seeking)
12-month assessment
|
2.61 units on a scale (range 1-4)
Standard Deviation 0.92
|
2.41 units on a scale (range 1-4)
Standard Deviation 0.91
|
|
Adaptive Coping Strategies (Social Support Seeking)
4-month assessment
|
2.60 units on a scale (range 1-4)
Standard Deviation 0.96
|
2.50 units on a scale (range 1-4)
Standard Deviation 0.96
|
|
Adaptive Coping Strategies (Social Support Seeking)
8-month assessment
|
2.77 units on a scale (range 1-4)
Standard Deviation 0.96
|
2.56 units on a scale (range 1-4)
Standard Deviation 0.92
|
Adverse Events
Intervention
Serious events: 22 serious events
Other events: 0 other events
Deaths: 1 deaths
No-treatment Control
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=171 participants at risk
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).
|
No-treatment Control
n=198 participants at risk
Participants who are assigned to the control group will not receive the intervention.
|
|---|---|---|
|
Nervous system disorders
Stroke and other nervous system disorder
|
3.5%
6/171 • Number of events 6 • 1 year
|
1.0%
2/198 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac-related hospitalization
|
2.9%
5/171 • Number of events 5 • 1 year
|
1.5%
3/198 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
GI related hospitalization
|
0.58%
1/171 • Number of events 1 • 1 year
|
0.51%
1/198 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory related hospitalization
|
1.8%
3/171 • Number of events 3 • 1 year
|
1.5%
3/198 • Number of events 3 • 1 year
|
|
Infections and infestations
Infection - hospitalization
|
1.2%
2/171 • Number of events 2 • 1 year
|
0.51%
1/198 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Accidents
|
2.3%
4/171 • Number of events 4 • 1 year
|
1.0%
2/198 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
General -surgery due to pre-existing conditions
|
0.58%
1/171 • Number of events 1 • 1 year
|
2.0%
4/198 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Kidney failure
|
0.00%
0/171 • 1 year
|
0.51%
1/198 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
General hospitalization
|
0.58%
1/171 • Number of events 1 • 1 year
|
0.00%
0/198 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place