Status:
COMPLETED
HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Conditions:
HIV/AIDS
Sexually Transmitted Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-ce...
Detailed Description
An estimated 56,300 Americans are newly infected with HIV every year. In addition, of the more than one million Americans living with HIV, approximately one-fifth do not know they are infected. Identi...
Eligibility Criteria
Inclusion
- Site Eligibility:
- high rates of STIs and HIV in their geographic target area,
- sufficient number of patients so that they would be able to recruit the required 556 participants over the study time period,
- prior participation in research and clinical studies, and
- previous collaboration with investigators.
- Participant eligibility:
- be seeking medical or health services at the participating STD clinic,
- be at least 18 years old,
- report being HIV-negative or status unknown,
- provide informed consent,
- provide locator information,
- be able to communicate in English,
- agree to be tested for STIs/STDs and HIV;
- sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment; and
- report living in the vicinity of the clinic and being able to return to the clinic for the 6-month follow-up visit.
Exclusion
- Sites:
- low rates of STIs and HIV in their geographic target area,
- insufficient number of patients to meet study needs of 556 per site
- no prior participation in research and clinical studies, and
- no previous collaboration with investigators.
- Participants:
- Not seeking medical or health services at the participating STD clinic,
- under 18 years old,
- HIV positive,
- unwilling to provide Informed Consent,
- refuse to provide locator information,
- not able to communicate in English,
- Disagree to be tested for STIs/STDs and/or HIV, and
- unwilling to sign a HIPAA form and/or medical record release form to permit medical record abstraction of HIV and STI/STD tests, results and treatment,
- report living out of the vicinity and unable to return to the clinic for the 6-month follow-up visit.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
5012 Patients enrolled
Trial Details
Trial ID
NCT01154296
Start Date
April 1 2010
End Date
February 1 2012
Last Update
September 29 2014
Active Locations (9)
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1
Los Angeles Gay & Lesbian Center
Los Angeles, California, United States, 90028
2
San Francisco Department of Public Health
San Francisco, California, United States, 94102
3
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States, 20009
4
Duval County Health Department
Jacksonville, Florida, United States, 32206