HIV Infections Clinical Trial
Official title:
Project UNITY - A Randomized Trial of Enhanced HIV Risk Reduction and Vaccine Education Interventions in Reducing Sexual Risk and Increasing Vaccine Trial Knowledge Among HIV-negative, High-risk Women Who Use Non-injection Drugs
Verified date | April 2014 |
Source | New York Blood Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | October 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - history of injection drug use in the previous 3 years; - pregnant; - intending to become pregnant in the next 12 months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | New York Blood Center - Project Achieve | Bronx | New York |
United States | New York Blood Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York Blood Center | Rutgers University, The New York Academy of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - an HIV risk score, the Vaginal Episode Equivalent (VEE) | approved prior to 12-1-12 | No | |
Primary | - understanding assessment for HIV vaccines. | approved prior to 12-1 2012 | No | |
Secondary | -frequency of use of specific drugs | approved prior to 12-1-12 | No | |
Secondary | -knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible | approved prior to 12-1-12 | No | |
Secondary | -adherence to hepatitis B vaccination schedule | approved prior to 12-1-12 | No | |
Secondary | -willingness to participate in HIV vaccine trials | approved prior to 12-1-12 | No | |
Secondary | -measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine | approved prior to 12-1-12 | No | |
Secondary | -incidence of pregnancy | approved prior to 12-1-12 | No |
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