Project UNITY - HIV Risk Reduction and Vaccine Education Interventions

Completed · Not applicable

Conditions studied: HIV Infections, Hepatitis B

In brief

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-negative, high-risk non-injection drug-using (NIDU) women. To determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk NIDU women.

Key facts

Study ID

NCT00150098

Run by

New York Blood Center

People needed

400

Starts

2005-02-01

Expected to finish

2010-10-01

Last updated by the study team

2014-04-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• history of injection drug use in the previous 3 years;
• pregnant;
• intending to become pregnant in the next 12 months.

Where it is running

• New York Blood Center — New York, New York, United States
• New York Blood Center - Project Achieve — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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