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

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.

Conditions

• HIV/AIDS
• Sexually Transmitted Infections

Interventions

BEHAVIORAL

RESPECT-2 Counseling

Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Pittsburgh

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Research Foundation for Mental Hygiene, Inc.

  collaborator OTHER

• Duke University

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• San Francisco Department of Public Health

  collaborator OTHER_GOV

• University of California

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Lisa R. Metsch, Ph.D. · University of Miami

• Grant N Colfax, M.D. · San Francisco Department of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2011-07-31

Completion

2012-02-29

Countries

• United States

Study Locations