A Randomized Trial of Vaccine Adherence in Young Injection Drug Users (UFO VAX)
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
Paula J Lum, MD MPH, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00244374
First received: October 25, 2005
Last updated: November 12, 2012
Last verified: November 2012
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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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]We compared anti-HBs seroconversion after three vaccine doses between anti-HCV positive and anti-HCV negative subjects.
- Viral transmission risk behavior [ Time Frame: 30 days ] [ Designated as safety issue: No ]In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel and behaviors that may facilitate the spread of viral infections, such as 30-day drug and alcohol and sexual risk behaviors. Subjects defined as travelers had "been on the road or traveling outside of San Francisco" in the prior 3 months.
- HIV vaccine trial attitudes [ Time Frame: Baseline ] [ Designated as safety issue: No ]In 409 screening study subjects, we assessed knowledge about vaccine trials and their willingness to participate in preventive HIV vaccine trials. Knowledge was assessed using eight questions about key vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET). Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing), in response to 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?"
| Enrollment: | 167 |
| 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:
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:
|
|
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:
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:
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:
|
|
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:
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:
|
|
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:
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:
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:
|
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
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: | Paula J Lum, MD MPH, Associate Professor, 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 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis C Substance Abuse, Intravenous Substance-Related Disorders Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013