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Barbershop Talk: HIV Prevention for African American Heterosexual Men

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ClinicalTrials.gov Identifier: NCT01980771
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Tracey Wilson, State University of New York - Downstate Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV
Interventions Behavioral: BTWB intervention
Behavioral: Cancer prevention and screening
Enrollment 860
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BTWB Intervention Cancer Prevention and Screening
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 436 424
Completed 352 305
Not Completed 84 119
Arm/Group Title BTWB Intervention Cancer Prevention and Screening Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 436 424 860
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 436 participants 424 participants 860 participants
31.4  (10.8) 34.7  (11.6) 33.0  (11.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 424 participants 860 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
436
 100.0%
424
 100.0%
860
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 424 participants 860 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
436
 100.0%
424
 100.0%
860
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 436 participants 424 participants 860 participants
436
 100.0%
424
 100.0%
860
 100.0%
Living with a sexual partner   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 422 participants 855 participants
80
  18.5%
85
  20.1%
165
  19.3%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
Current health insurance   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 419 participants 847 participants
269
  62.9%
300
  71.6%
569
  67.2%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
Currently employed   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 422 participants 854 participants
201
  46.5%
229
  54.3%
430
  50.4%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
High school degree or equivalent   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 421 participants 854 participants
335
  77.4%
321
  76.2%
656
  76.8%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
Born in U.S.  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 424 participants 860 participants
233
  53.4%
324
  76.4%
557
  64.8%
In stable housing   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 423 participants 854 participants
363
  84.2%
290
  68.6%
653
  76.5%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
No substance use (excludes marijuana)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants 424 participants 857 participants
392
  90.5%
351
  82.8%
743
  86.7%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
No alcohol use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 422 participants 858 participants
112
  25.7%
95
  22.5%
207
  24.1%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
No incarceration history   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 435 participants 421 participants 856 participants
197
  45.3%
248
  58.9%
445
  52.0%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
No condomless sex   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 431 participants 421 participants 852 participants
237
  55.0%
205
  48.7%
442
  51.9%
[1]
Measure Analysis Population Description: Missing baseline data; respondent did not answer
1.Primary Outcome
Title Sexual Behavior
Hide Description Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.
Time Frame Six month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title BTWB Intervention Cancer Prevention and Screening
Hide Arm/Group Description:
Men work in groups on a single session intervention.
Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
Overall Number of Participants Analyzed 347 303
Measure Type: Count of Participants
Unit of Measure: Participants
225
  64.8%
163
  53.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BTWB Intervention, Cancer Prevention and Screening
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
1.03 to 2.43
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BTWB Intervention Cancer Prevention and Screening
Hide Arm/Group Description Men work in groups on a single session intervention. Men are provided with health education about prostate cancer screening and prevention in a single-session group format.
All-Cause Mortality
BTWB Intervention Cancer Prevention and Screening
Affected / at Risk (%) Affected / at Risk (%)
Total   0/436 (0.00%)      0/424 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
BTWB Intervention Cancer Prevention and Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/436 (0.00%)      0/424 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BTWB Intervention Cancer Prevention and Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/436 (0.46%)      3/424 (0.71%)    
Social circumstances     
Incarceration * [1]  2/436 (0.46%)  2 3/424 (0.71%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Participants incarcerated or at an in-patient facility as reported by contacts
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tracey Wilson, Principal Investigator
Organization: State University of New York, Downstate Medical Center
Phone: 718 270 2105
Responsible Party: Tracey Wilson, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT01980771     History of Changes
Other Study ID Numbers: 5P20MD006875, subproject 5174
5P20MD006875 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2013
First Posted: November 11, 2013
Results First Submitted: August 16, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018