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NCT01154296 · ClinicalTrials.gov registry record · NA
HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 5,012
- Enrollment target
NCT01154296: Completed NA study, sponsored by Columbia University.
NCT01154296 is a NA study that has completed, run by Columbia University. The registered enrollment target is 5,012 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (257% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154296, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 5,012 participants
- Enrollment target
Study Summary
Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. The investigators will evaluate the effect of counseling on one primary outcome: STI incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants will be assessed for sexually transmitted infections, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. Approximately 5,000 individuals seeking medical or health services from approximately 9 STD clinics throughout the United States will be randomized. These individuals will be 18 years of age or older and efforts will be made to recruit a sample of study participants that reflects the proportion of minorities and gender in the STD clinic performance sites from which the investigators are recruiting.
Primary Outcome
Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.
Interventions
- BEHAVIORAL RESPECT-2 Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,012 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-02 |
| Phase | NA |
What the finished NCT01154296 record still lists
NCT01154296 is an interventional study that assigns participants to a tested intervention. Its 5,012 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (257% higher).
The record links to 0 conditions, and to 1 intervention - of which RESPECT-2 Counseling is the first listed.
NCT01154296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01154296 about?
NCT01154296 is a clinical study titled "HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.". Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and ...
What is the current status of trial NCT01154296?
This trial is currently completed. It is a NA study. The enrollment target is 5,012 participants. The study started on 2010-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01154296?
The interventions under investigation include: RESPECT-2 Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01154296?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01154296's enrollment target sits among peer trials
5,012 25th of 2000 higher than 1,976 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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