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Completed Not applicable Interventional Accepts healthy volunteers Results available

HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.

ClinicalTrials.gov ID: NCT01154296

Public ClinicalTrials.gov record NCT01154296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Project Aware: HIV Rapid Testing & Counseling in STD Clinics in the U.S. -- an Adaptation of CTN 0032

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01154296
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Columbia University
Other
Enrollment
5,012 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2010
Primary completion
Jun 30, 2011
Completion
Jan 31, 2012
Last update posted
Sep 28, 2014

2010 – 2012

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Los Angeles Gay & Lesbian Center Los Angeles California 90028
San Francisco Department of Public Health San Francisco California 94102
Whitman-Walker Clinic Washington D.C. District of Columbia 20009
Duval County Health Department Jacksonville Florida 32206
Miami-Dade County Health Department Miami Florida 33125
Multnomah County Health Department Portland Oregon 97204
Allegheny County Health Department Pittsburgh Pennsylvania 15213
Richland County Health Department Colombia South Carolina 29204
Public Health Seattle & King County Seattle Washington 98107

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01154296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2014 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01154296 live on ClinicalTrials.gov.

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