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NCT01607541 · ClinicalTrials.gov registry record · Phase 2
Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
A Phase 2 study, sponsored by New York University.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,400
- Enrollment target
NCT01607541 is a Phase 2 study that has completed, run by New York University. The registered enrollment target is 3,400 participants.
The verdict
NCT01607541, a Phase 2 study, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,400 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Control intervention
- BEHAVIORAL BCAP peer-driven intervention (PDI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,400 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01607541
The ClinicalTrials.gov registry entry for NCT01607541 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control intervention is the first listed.
NCT01607541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01607541 about?
NCT01607541 is a clinical study titled "Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV". 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...
What is the current status of trial NCT01607541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,400 participants. The study started on 2012-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01607541?
The interventions under investigation include: Control intervention (BEHAVIORAL), BCAP peer-driven intervention (PDI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01607541?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
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