Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
NCT01607541 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3400
Last updated 2022-11-03
Summary
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. The investigators research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR in central Brooklyn.
The primary goal of the proposed study is to evaluate the efficacy of a peer-driven intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a peer-based approach) versus venue-based sampling (a location-based approach).
The two main study hypotheses are:
(H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV compared to those recruited via venue-based sampling (VBS).
H2): Participants in the "Test and Treat: phase of the peer-driven intervention (all of whom will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time to starting HIV medication (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.
Conditions
Interventions
- BEHAVIORAL
-
BCAP peer-driven intervention (PDI)
The Brooklyn Community Action Project (BCAP) PDI entails structured sessions including the computerized "CARE for Prevention" tool, 3 peer education experiences, and 6 months of navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and navigation).
- BEHAVIORAL
-
Control intervention
The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
New York University
lead OTHER
Principal Investigators
-
Marya Gwadz, PhD · New York University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2015-02-28
- Completion
- 2016-04-30
Countries
- United States
Study Locations
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