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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00244374
First received: October 25, 2005
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Medication Adherence
Substance Abuse, Intravenous
Risk Behavior
Hepatitis A
Hepatitis B
Hepatitis C
Biological: Hepatitis A & B vaccine
Behavioral: Outreach
Behavioral: AIC
Behavioral: SEP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Vaccine Adherence in Young IDU

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Vaccine Series Completion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome was the completion of the four-dose vaccine series in a 12 month period.


Secondary Outcome Measures:
  • Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Viral Transmission Risk Behavior Association With Travel [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • HIV Vaccine Trial Willingness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • HIV Vaccine Trial Knowledge [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


Enrollment: 546
Study Start Date: August 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Twinrix
  • Engerix-B
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:
  • Twinrix
  • Engerix-B
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: 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: 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:
  • Twinrix
  • Engerix-B
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:
  • Twinrix
  • Engerix-B
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)

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.

  Eligibility

Ages Eligible for Study:   14 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244374

Locations
United States, California
University of California San Francisco Medical Cen
San Francisco, California, United States, 94143 0939
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Paula J Lum, M.D., M.P.H. University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00244374     History of Changes
Other Study ID Numbers: NIDA-17476-1, R01DA017476
Study First Received: October 25, 2005
Results First Received: April 25, 2013
Last Updated: July 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Substance Abuse, Intravenous
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014