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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: Completed Phase 2 study, sponsored by New York University.

NCT01607541 is a Phase 2 study that has completed, run by New York University. The registered enrollment target is 3,400 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2456% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 3,400 participants
Start Date 2012-04
Est. Completion 2016-04
Phase Phase 2
New York University

83 total trials

What the finished NCT01607541 record still lists

NCT01607541 is an interventional study that assigns participants to a tested intervention. Its 3,400 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2456% higher).

The record links to 0 conditions, and to 2 interventions - of which Control intervention is the first listed.

NCT01607541 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01607541's enrollment target sits among peer trials

3,400 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01607541, the US trial registry maintained by the National Library of Medicine. NCT01607541 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.