A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
UFO VAX
2 other identifiers
interventional
546
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
July 19, 2013
CompletedSeptember 30, 2013
July 1, 2013
3.8 years
October 25, 2005
April 25, 2013
July 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Vaccine Series Completion
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
12 months
Secondary Outcomes (4)
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
12 months
Viral Transmission Risk Behavior Association With Travel
Baseline
HIV Vaccine Trial Willingness
Baseline
HIV Vaccine Trial Knowledge
Baseline
Study Arms (4)
AIC, Hepatitis A & B vaccine
EXPERIMENTALSubjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
AIC, Outreach, Hepatitis A & B vaccine
EXPERIMENTALAIC + 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
SEP, Hepatitis A & B vaccine
EXPERIMENTALSEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
SEP, Outreach, Hepatitis A & B vaccine
EXPERIMENTALSubjects 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
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- age 14-29 at screening
- injected drugs in the prior 30 days
You may not qualify if:
- Prior positive HIV antibody test
- Prior HBV immunization
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco Medical Cen
San Francisco, California, 94143 0939, United States
Related Publications (3)
Hahn JA, Page-Shafer K, Ford J, Paciorek A, Lum PJ. Traveling young injection drug users at high risk for acquisition and transmission of viral infections. Drug Alcohol Depend. 2008 Jan 11;93(1-2):43-50. doi: 10.1016/j.drugalcdep.2007.08.016. Epub 2007 Nov 5.
PMID: 17980513RESULTEtcheverry MF, Lum PJ, Evans JL, Sanchez E, de Lazzari E, Mendez-Arancibia E, Sierra E, Gatell JM, Page K, Joseph J. HIV vaccine trial willingness among injection and non-injection drug users in two urban centres, Barcelona and San Francisco. Vaccine. 2011 Feb 24;29(10):1991-6. doi: 10.1016/j.vaccine.2010.12.043. Epub 2011 Jan 15.
PMID: 21241735RESULTLum PJ, Hahn JA, Shafer KP, Evans JL, Davidson PJ, Stein E, Moss AR. Hepatitis B virus infection and immunization status in a new generation of injection drug users in San Francisco. J Viral Hepat. 2008 Mar;15(3):229-36. doi: 10.1111/j.1365-2893.2007.00933.x.
PMID: 18233994RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paula J. Lum
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Paula J Lum, M.D., M.P.H.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2005
First Posted
October 26, 2005
Study Start
August 1, 2004
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
September 30, 2013
Results First Posted
July 19, 2013
Record last verified: 2013-07