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
Sponsor study identifier
Secondary identifiers
interventional
400
1 country
2
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
October 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 6, 2005
Actual (reported)September 8, 2005
Actual (reported)November 2009
Actual (reported)October 2010
Actual (reported)- an HIV risk score, the Vaginal Episode Equivalent (VEE)
approved prior to 12-1-12
- understanding assessment for HIV vaccines.
approved prior to 12-1 2012
-frequency of use of specific drugs
approved prior to 12-1-12
-knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible
approved prior to 12-1-12
-adherence to hepatitis B vaccination schedule
approved prior to 12-1-12
-willingness to participate in HIV vaccine trials
approved prior to 12-1-12
-measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine
approved prior to 12-1-12
Education
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New York Blood Center
New York, New York, 10021, United States
New York Blood Center - Project Achieve
The Bronx, New York, 10455, United States
Koblin BA, Bonner S, Hoover DR, Xu G, Lucy D, Fortin P, Putnam S, Latka MH. A randomized trial of enhanced HIV risk-reduction and vaccine trial education interventions among HIV-negative, high-risk women who use noninjection drugs: the UNITY study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):378-87. doi: 10.1097/QAI.0b013e3181b7222e.
Beryl A Koblin, Ph.D.
New York Blood Center
400 participants (actual enrollment reported by the registry).
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV
Contact the study team to confirm eligibility.
Primary Completion
November 2009
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
April 8, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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