Status:
COMPLETED
Project UNITY - HIV Risk Reduction and Vaccine Education Interventions
Lead Sponsor:
New York Blood Center
Collaborating Sponsors:
The New York Academy of Medicine
Rutgers University
Conditions:
HIV Infections
Hepatitis B
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-nega...
Detailed Description
We are currently screening women (approximately 535) from whom we expect 400 HIV-negative high-risk, non-pregnant NIDU women will be enrolled to participate in a two-arm randomized trial of an enhance...
Eligibility Criteria
Inclusion
- at least 18 years of age;
- non-injecting use of heroin, cocaine or crack cocaine in the last six months;
- unprotected vaginal sex in the last three months;
- test HIV antibody negative;
- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
- ability to understand spoken English or Spanish;
- agree to be randomized;
- willing to return for visits at 1, 6, and 12 months post-enrollment;
- willing and able to provide informed consent.
Exclusion
- history of injection drug use in the previous 3 years;
- pregnant;
- intending to become pregnant in the next 12 months.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00150098
Start Date
February 1 2005
End Date
October 1 2010
Last Update
April 8 2014
Active Locations (2)
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1
New York Blood Center
New York, New York, United States, 10021
2
New York Blood Center - Project Achieve
The Bronx, New York, United States, 10455