Project UNITY - HIV Risk Reduction and Vaccine Education Interventions

This study has been completed.
Sponsor:
Collaborators:
The New York Academy of Medicine
Rutgers University
Information provided by:
New York Blood Center
ClinicalTrials.gov Identifier:
NCT00150098
First received: September 6, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention
HIV Infections
Hepatitis B
Behavioral: Enhanced HIV risk reduction and HIV vaccine education

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York Blood Center:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • -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 ]

Enrollment: 400
Study Start Date: February 2005
Study Completion Date: October 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lifestyle counselling
Education
Behavioral: Enhanced HIV risk reduction and HIV vaccine education

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150098

Locations
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
Investigators
Principal Investigator: Beryl A Koblin, Ph.D. New York Blood Center
  More Information

No publications provided by New York Blood Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150098     History of Changes
Other Study ID Numbers: IRB 406-04, 5R01DA017482-03
Study First Received: September 6, 2005
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York Blood Center:
HIV
vaccines
women
substance use

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 23, 2014