HIV
Conditions
Keywords
HIV, prevention, men, African American
Brief summary
This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.
Interventions
BEHAVIORALBTWB intervention
Men work in groups to complete a intervention that takes approximately two hours to complete.
BEHAVIORALCancer prevention and screening
Men are provided health education about cancer screening and prevention
Sponsors
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
State University of New York - Downstate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Unprotected sex in the past three months * Identify as Black or African American
Exclusion criteria
* Having been in an HIV prevention research study in the last six months * Reporting a history in the past five years of injection drug use * Reporting a history in the past five years of having sex with other men * Reporting an HIV-positive serostatus * Inability to understand spoken English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Behavior | Six month follow-up | Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 436 |
| 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 | 424 |
| Total | 860 |
Baseline characteristics
| Characteristic | Cancer Prevention and Screening | BTWB Intervention | Total |
|---|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 11.6 | 31.4 years STANDARD_DEVIATION 10.8 | 33.0 years STANDARD_DEVIATION 11.3 |
| Born in U.S. | 324 Participants | 233 Participants | 557 Participants |
| Current health insurance | 300 Participants | 269 Participants | 569 Participants |
| Currently employed | 229 Participants | 201 Participants | 430 Participants |
| High school degree or equivalent | 321 Participants | 335 Participants | 656 Participants |
| In stable housing | 290 Participants | 363 Participants | 653 Participants |
| Living with a sexual partner | 85 Participants | 80 Participants | 165 Participants |
| No alcohol use | 95 Participants | 112 Participants | 207 Participants |
| No condomless sex | 205 Participants | 237 Participants | 442 Participants |
| No incarceration history | 248 Participants | 197 Participants | 445 Participants |
| No substance use (excludes marijuana) | 351 Participants | 392 Participants | 743 Participants |
| 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 | 424 Participants | 436 Participants | 860 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 424 Participants | 436 Participants | 860 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 424 Participants | 436 Participants | 860 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 436 | 0 / 424 |
| other Total, other adverse events | 2 / 436 | 3 / 424 |
| serious Total, serious adverse events | 0 / 436 | 0 / 424 |
Outcome results
Primary
Sexual Behavior
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BTWB Intervention | Sexual Behavior | 225 Participants |
| Cancer Prevention and Screening | Sexual Behavior | 163 Participants |
p-value: 0.0495% CI: [1.03, 2.43]Mixed Models Analysis