A Randomized Trial of Vaccine Adherence in Young Injection Drug Users (UFO VAX)

July 25, 2013 updated by: University of California, San Francisco

A Randomized Trial of Vaccine Adherence in Young IDU

The purpose of this study is to compare the effects of (a) immunization setting and (b) outreach worker support on young injection drug users' (IDU) adherence to a multiple dose immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B virus (HBV) recombinant vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a research trial consisting of a cross-sectional screening study and a prospective cohort study (randomized, 2x2 factorial design). The primary aim of the study is to evaluate the effects of immunization setting and outreach worker support on young IDU's adherence to a multiple dose immunization schedule with a combined HAV and HBV vaccine. Secondarily, the study will 1) explore the feasibility of a remote immunization network and web-based vaccine registry to improve immunization coverage of transient young IDU, 2) examine the effect of hepatitis C virus (HCV) infection in vaccine effectiveness, and 3) assess behavior change and vaccine attitudes in young IDU participating in a preventive vaccine trial.

Subjects in the screening study complete an interview, receive counseling and testing for HIV, HAV, HBV and HCV, and return in one week for test results and risk reduction counseling. Subjects eligible for the cohort study receive their first immunizations at enrollment and then are randomized to receive subsequent vaccines at either a set of syringe exchange programs (SEP) or at a public health adult immunization clinic (AIC). Subjects also are randomized to receive vaccine reminders from an outreach worker or no outreach worker support. Each subject receives a total of 4 immunizations over 6 months. Follow up visits include interviews, counseling, and viral testing. Study participation is for 12 months.

Study Type

Interventional

Enrollment (Actual)

546

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143 0939
        • University of California San Francisco Medical Cen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (screening study):

  • age 14-29 at screening
  • injected drugs in the prior 30 days

Exclusion Criteria (screening study):

  • Prior positive HIV antibody test
  • Prior HBV immunization

Inclusion Criteria (vaccine cohort):

  • participated in the screening study
  • tested negative for HIV-1 antibody and HBV markers in the screening study
  • returned for screening test results within 30 days of testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIC, Hepatitis A & B vaccine
Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
Biological: Hepatitis A & B vaccine
Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
Other Names:
  • Engerix-B
  • Twinrix
Behavioral: AIC
The Adult Immunization Clinic (AIC) is a public low-cost vaccine clinic located centrally at 101 Grove Street in the lobby of the San Francisco Department of Public Health (SFDPH). The clinic is open from Monday-Friday 9 a.m. to 4 p.m. Nurses at the AIC will be available 40 hours/week to administer free immunizations to study subjects.
Other Names:
  • Adult Immunization Clinic (AIC)
  • San Francisco Department of Public Health (SFDPH)
Experimental: AIC, Outreach, Hepatitis A & B vaccine
AIC + outreach: Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
Biological: Hepatitis A & B vaccine
Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
Other Names:
  • Engerix-B
  • Twinrix
Behavioral: AIC
The Adult Immunization Clinic (AIC) is a public low-cost vaccine clinic located centrally at 101 Grove Street in the lobby of the San Francisco Department of Public Health (SFDPH). The clinic is open from Monday-Friday 9 a.m. to 4 p.m. Nurses at the AIC will be available 40 hours/week to administer free immunizations to study subjects.
Other Names:
  • Adult Immunization Clinic (AIC)
  • San Francisco Department of Public Health (SFDPH)
Behavioral: Outreach
Outreach worker vaccine adherence support: Half of cohort subjects will be assigned to outreach worker vaccine adherence support and will meet with their outreach workers from Haight Ashbury Youth Outreach Team (HAYOT) and Glide Health Services on the day of vaccine cohort study enrollment. Intensive vaccination tracking and in-person outreach support will begin one week before the second and third vaccine doses are due, and again two weeks before the fourth dose is due.
Other Names:
  • Haight Ashbury Youth Outreach Team (HAYOT)
  • Glide Health Services
Experimental: SEP, Hepatitis A & B vaccine
SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
Biological: Hepatitis A & B vaccine
Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
Other Names:
  • Engerix-B
  • Twinrix
Behavioral: SEP
Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Research nurses will provide 16 hours/week of vaccine administration services at SEPs well attended by young IDU. The San Francisco Needle Exchange (SFNE) serves primarily youth and young adults on Mondays, Wednesdays, and Fridays from 5-7 p.m. in an indoor location in the Haight-Ashbury district. A study nurse will be at SFNE for a total of 6 hours per week. HIV Prevention Project (HPP) sites also operate for 2 hrs each (Tues, Thu, Fri, Sat). Medical services are provided either in a clinic setting at indoor sites (6th Street) or at outdoor sites (Hemlock Alley, Duboce). A study nurse will attend each of these 5 weekly sites for a total of 10 hours/week.
Other Names:
  • syringe exchange
  • needle exchange
  • harm reduction
  • San Francisco Needle Exchange (SFNE)
  • HIV Prevention Project (HPP)
Experimental: SEP, Outreach, Hepatitis A & B vaccine
Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
Biological: Hepatitis A & B vaccine
Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.
Other Names:
  • Engerix-B
  • Twinrix
Behavioral: Outreach
Outreach worker vaccine adherence support: Half of cohort subjects will be assigned to outreach worker vaccine adherence support and will meet with their outreach workers from Haight Ashbury Youth Outreach Team (HAYOT) and Glide Health Services on the day of vaccine cohort study enrollment. Intensive vaccination tracking and in-person outreach support will begin one week before the second and third vaccine doses are due, and again two weeks before the fourth dose is due.
Other Names:
  • Haight Ashbury Youth Outreach Team (HAYOT)
  • Glide Health Services
Behavioral: SEP
Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Research nurses will provide 16 hours/week of vaccine administration services at SEPs well attended by young IDU. The San Francisco Needle Exchange (SFNE) serves primarily youth and young adults on Mondays, Wednesdays, and Fridays from 5-7 p.m. in an indoor location in the Haight-Ashbury district. A study nurse will be at SFNE for a total of 6 hours per week. HIV Prevention Project (HPP) sites also operate for 2 hrs each (Tues, Thu, Fri, Sat). Medical services are provided either in a clinic setting at indoor sites (6th Street) or at outdoor sites (Hemlock Alley, Duboce). A study nurse will attend each of these 5 weekly sites for a total of 10 hours/week.
Other Names:
  • syringe exchange
  • needle exchange
  • harm reduction
  • San Francisco Needle Exchange (SFNE)
  • HIV Prevention Project (HPP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine Series Completion
Time Frame: 12 months
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
Time Frame: 12 months
To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.
12 months
Viral Transmission Risk Behavior Association With Travel
Time Frame: Baseline
In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.
Baseline
HIV Vaccine Trial Willingness
Time Frame: Baseline
We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: "How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?". Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing).
Baseline
HIV Vaccine Trial Knowledge
Time Frame: Baseline

Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET).

  1. Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative.
  2. Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance).
  3. Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies.
  4. Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe.
  5. Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies.
  6. HIV vaccines will never affect a person's HIV test results.
  7. An HIV vaccine can infect a person with HIV disease.
  8. People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Paula J Lum, M.D., M.P.H., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-17476-1
  • R01DA017476 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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