Trial Outcomes & Findings for Barbershop Talk: HIV Prevention for African American Heterosexual Men (NCT NCT01980771)
NCT ID: NCT01980771
Last Updated: 2021-10-27
Results Overview
Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
860 participants
Primary outcome timeframe
Six month follow-up
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
BTWB Intervention
Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention.
BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete.
|
Cancer Prevention and Screening
Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control.
Cancer prevention and screening: Men are provided health education about cancer screening and prevention
|
|---|---|---|
|
Overall Study
STARTED
|
436
|
424
|
|
Overall Study
COMPLETED
|
352
|
305
|
|
Overall Study
NOT COMPLETED
|
84
|
119
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing baseline data; respondent did not answer
Baseline characteristics by cohort
| Measure |
BTWB Intervention
n=436 Participants
Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention.
BTWB intervention: Men work in groups to complete a intervention that takes approximately two hours to complete.
|
Cancer Prevention and Screening
n=424 Participants
Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control.
Cancer prevention and screening: Men are provided health education about cancer screening and prevention
|
Total
n=860 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 10.8 • n=436 Participants
|
34.7 years
STANDARD_DEVIATION 11.6 • n=424 Participants
|
33.0 years
STANDARD_DEVIATION 11.30 • n=860 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Sex: Female, Male
Male
|
436 Participants
n=436 Participants
|
424 Participants
n=424 Participants
|
860 Participants
n=860 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Race (NIH/OMB)
Black or African American
|
436 Participants
n=436 Participants
|
424 Participants
n=424 Participants
|
860 Participants
n=860 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=436 Participants
|
0 Participants
n=424 Participants
|
0 Participants
n=860 Participants
|
|
Region of Enrollment
United States
|
436 Participants
n=436 Participants
|
424 Participants
n=424 Participants
|
860 Participants
n=860 Participants
|
|
Living with a sexual partner
|
80 Participants
n=433 Participants • Missing baseline data; respondent did not answer
|
85 Participants
n=422 Participants • Missing baseline data; respondent did not answer
|
165 Participants
n=855 Participants • Missing baseline data; respondent did not answer
|
|
Current health insurance
|
269 Participants
n=428 Participants • Missing baseline data; respondent did not answer
|
300 Participants
n=419 Participants • Missing baseline data; respondent did not answer
|
569 Participants
n=847 Participants • Missing baseline data; respondent did not answer
|
|
Currently employed
|
201 Participants
n=432 Participants • Missing baseline data; respondent did not answer
|
229 Participants
n=422 Participants • Missing baseline data; respondent did not answer
|
430 Participants
n=854 Participants • Missing baseline data; respondent did not answer
|
|
High school degree or equivalent
|
335 Participants
n=433 Participants • Missing baseline data; respondent did not answer
|
321 Participants
n=421 Participants • Missing baseline data; respondent did not answer
|
656 Participants
n=854 Participants • Missing baseline data; respondent did not answer
|
|
Born in U.S.
|
233 Participants
n=436 Participants
|
324 Participants
n=424 Participants
|
557 Participants
n=860 Participants
|
|
In stable housing
|
363 Participants
n=431 Participants • Missing baseline data; respondent did not answer
|
290 Participants
n=423 Participants • Missing baseline data; respondent did not answer
|
653 Participants
n=854 Participants • Missing baseline data; respondent did not answer
|
|
No substance use (excludes marijuana)
|
392 Participants
n=433 Participants • Missing baseline data; respondent did not answer
|
351 Participants
n=424 Participants • Missing baseline data; respondent did not answer
|
743 Participants
n=857 Participants • Missing baseline data; respondent did not answer
|
|
No alcohol use
|
112 Participants
n=436 Participants • Missing baseline data; respondent did not answer
|
95 Participants
n=422 Participants • Missing baseline data; respondent did not answer
|
207 Participants
n=858 Participants • Missing baseline data; respondent did not answer
|
|
No incarceration history
|
197 Participants
n=435 Participants • Missing baseline data; respondent did not answer
|
248 Participants
n=421 Participants • Missing baseline data; respondent did not answer
|
445 Participants
n=856 Participants • Missing baseline data; respondent did not answer
|
|
No condomless sex
|
237 Participants
n=431 Participants • Missing baseline data; respondent did not answer
|
205 Participants
n=421 Participants • Missing baseline data; respondent did not answer
|
442 Participants
n=852 Participants • Missing baseline data; respondent did not answer
|
PRIMARY outcome
Timeframe: Six month follow-upPopulation: 352 men completed the six month assessment in the intervention arm; of these 347 provided complete data needed to calculate the outcome measure. 305 men completed the six month assessment in the control arm; of these 303 provided complete data needed to calculate the outcome measure.
Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.
Outcome measures
| Measure |
BTWB Intervention
n=347 Participants
Men work in groups on a single session intervention.
|
Cancer Prevention and Screening
n=303 Participants
Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
|
|---|---|---|
|
Sexual Behavior
|
225 Participants
|
163 Participants
|
Adverse Events
BTWB Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cancer Prevention and Screening
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BTWB Intervention
n=436 participants at risk
Men work in groups on a single session intervention.
|
Cancer Prevention and Screening
n=424 participants at risk
Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
|
|---|---|---|
|
Social circumstances
Incarceration
|
0.46%
2/436 • Number of events 2 • 6 months
|
0.71%
3/424 • Number of events 3 • 6 months
|
Additional Information
Tracey Wilson, Principal Investigator
State University of New York, Downstate Medical Center
Phone: 718 270 2105
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place