NCT00244374|CompletedResults
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
UFO VAX
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UFO VAX
Sponsor study identifier
Secondary identifiers
NIH
interventional
546
1 country
1
Study Start
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
October 25, 2005
Actual (reported)October 26, 2005
Actual (reported)June 2008
Actual (reported)June 2008
Actual (reported)July 19, 2013
Actual (reported)Vaccine Series Completion
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
12 months
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
12 months
Viral Transmission Risk Behavior Association With Travel
Baseline
Subjects 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: 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
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.
University of California San Francisco Medical Cen
San Francisco, California, 94143 0939, United States
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.
Etcheverry 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.
Paula J Lum, M.D., M.P.H.
University of California, San Francisco
546 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2005
First Posted
October 26, 2005
Study Start
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
A Video-Based HCV Curriculum for Active Injection Drug Users
HIV Vaccine Trial Willingness
Baseline
HIV Vaccine Trial Knowledge
Baseline
SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lum 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.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
September 30, 2013
Results First Posted
July 19, 2013
Record last verified: 2013-07
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Source: ClinicalTrials.gov.
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