Project UNITY - HIV Risk Reduction and Vaccine Education Interventions
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.
Behavioral: Enhanced HIV risk reduction and HIV vaccine education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|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|
- - an HIV risk score, the Vaginal Episode Equivalent (VEE) [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- - understanding assessment for HIV vaccines. [ Time Frame: approved prior to 12-1 2012 ] [ Designated as safety issue: No ]
- -frequency of use of specific drugs [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- -knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- -adherence to hepatitis B vaccination schedule [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- -willingness to participate in HIV vaccine trials [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- -measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
- -incidence of pregnancy [ Time Frame: approved prior to 12-1-12 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: lifestyle counselling
|Behavioral: Enhanced HIV risk reduction and HIV vaccine education|
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 enhanced HIV risk reduction intervention plus an enhanced vaccine education intervention compared to controls. At screening, women complete an assessment, receive HIV and HBV pre-test counseling, and are tested for HIV antibody, markers of hepatitis B virus (HBV) infection and pregnancy. At the enrollment visit (2 weeks later), eligible and willing participants are randomized to receive either the enhanced HIV risk reduction intervention plus the enhanced vaccine education intervention or control conditions. Enrolled women provide urine for pregnancy testing. Enrolled women found to be susceptible to HBV are offered hepatitis B (HB) vaccine at the enrollment visit. Follow-up visits coincide with the HB vaccine schedule (1 and 6 months post enrollment) for all women, regardless of whether or not they received HB vaccine. Pregnancy testing is conducted at these follow-up visits. Participants provide sera for HIV antibody testing at the 6- and 12-months visits. A final visit will occur at 12 months post enrollment to assess longer term effects on risk behaviors and knowledge and understanding of vaccine concepts. All standardized interviews are conducted using Audio Computer Assisted Self-Interview (ACASI) technology.
The enhanced HIV risk reduction intervention is a series of three, interactive, individually-delivered, counseling sessions. The enhanced sessions also include tailored male and female condom demonstrations to build skills, and each session concludes with a client-initiated sexual risk reduction goal. The follow-up sessions (at 1 and 6 months) resume by reviewing goal attainment, exploring the reasons and beliefs associated with progress toward that goal. The control group receives the client-centered HIV counseling based on the Centers for Disease Control and Prevention (CDC) Project RESPECT model. Both the control and enhanced risk reduction counseling are delivered at the baseline (time 0) and at follow up visits (1 month and 6 months).
The enhanced vaccine education component will test the two-session model informed consent process outlined by Coletti et al but enhanced with simplified illustrated educational material delivered through flipcharts, video and individual counseling at baseline and 1 week later. The control condition is based on the Coletti two-session informed consent process.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150098
|United States, New York|
|New York Blood Center - Project Achieve|
|Bronx, New York, United States, 10455|
|New York Blood Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Beryl A Koblin, Ph.D.||New York Blood Center|