Working… Menu

Project UNITY - HIV Risk Reduction and Vaccine Education Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150098
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 8, 2014
The New York Academy of Medicine
Rutgers University
Information provided by:
New York Blood Center

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-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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Behavioral: Enhanced HIV risk reduction and HIV vaccine education Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: lifestyle counselling
Behavioral: Enhanced HIV risk reduction and HIV vaccine education

Primary Outcome Measures :
  1. - an HIV risk score, the Vaginal Episode Equivalent (VEE) [ Time Frame: approved prior to 12-1-12 ]
  2. - understanding assessment for HIV vaccines. [ Time Frame: approved prior to 12-1 2012 ]

Secondary Outcome Measures :
  1. -frequency of use of specific drugs [ Time Frame: approved prior to 12-1-12 ]
  2. -knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible [ Time Frame: approved prior to 12-1-12 ]
  3. -adherence to hepatitis B vaccination schedule [ Time Frame: approved prior to 12-1-12 ]
  4. -willingness to participate in HIV vaccine trials [ Time Frame: approved prior to 12-1-12 ]
  5. -measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine [ Time Frame: approved prior to 12-1-12 ]
  6. -incidence of pregnancy [ Time Frame: approved prior to 12-1-12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150098

Layout table for location information
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
Sponsors and Collaborators
New York Blood Center
The New York Academy of Medicine
Rutgers University
Layout table for investigator information
Principal Investigator: Beryl A Koblin, Ph.D. New York Blood Center

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00150098     History of Changes
Other Study ID Numbers: IRB 406-04
5R01DA017482-03 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by New York Blood Center:
substance use
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis B
Liver Diseases
Digestive System Diseases
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Immunologic Factors
Physiological Effects of Drugs