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

Primary Purpose

Medication Adherence, Substance Abuse, Intravenous, Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatitis A & B vaccine
Outreach
AIC
SEP
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Adherence

Eligibility Criteria

14 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco Medical Cen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AIC, Hepatitis A & B vaccine

AIC, Outreach, Hepatitis A & B vaccine

SEP, Hepatitis A & B vaccine

SEP, Outreach, Hepatitis A & B vaccine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 25, 2005
Last Updated
July 25, 2013
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00244374
Brief Title
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
Acronym
UFO VAX
Official Title
A Randomized Trial of Vaccine Adherence in Young IDU
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Substance Abuse, Intravenous, Risk Behavior, Hepatitis A, Hepatitis B, Hepatitis C

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
546 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIC, Hepatitis A & B vaccine
Arm Type
Experimental
Arm Description
Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
Arm Title
AIC, Outreach, Hepatitis A & B vaccine
Arm Type
Experimental
Arm Description
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
Arm Title
SEP, Hepatitis A & B vaccine
Arm Type
Experimental
Arm Description
SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
Arm Title
SEP, Outreach, Hepatitis A & B vaccine
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Hepatitis A & B vaccine
Other Intervention Name(s)
Twinrix, Engerix-B
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Outreach
Other Intervention Name(s)
Haight Ashbury Youth Outreach Team (HAYOT), Glide Health Services
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AIC
Other Intervention Name(s)
Adult Immunization Clinic (AIC), San Francisco Department of Public Health (SFDPH)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SEP
Other Intervention Name(s)
syringe exchange, needle exchange, harm reduction, San Francisco Needle Exchange (SFNE), HIV Prevention Project (HPP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccine Series Completion
Description
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
Description
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.
Time Frame
12 months
Title
Viral Transmission Risk Behavior Association With Travel
Description
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.
Time Frame
Baseline
Title
HIV Vaccine Trial Willingness
Description
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).
Time Frame
Baseline
Title
HIV Vaccine Trial Knowledge
Description
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). Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative. Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance). Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies. Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe. Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies. HIV vaccines will never affect a person's HIV test results. An HIV vaccine can infect a person with HIV disease. People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula J Lum, M.D., M.P.H.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Medical Cen
City
San Francisco
State/Province
California
ZIP/Postal Code
94143 0939
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17980513
Citation
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.
Results Reference
result
PubMed Identifier
21241735
Citation
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.
Results Reference
result
PubMed Identifier
18233994
Citation
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.
Results Reference
result
Links:
URL
http://caps.ucsf.edu/resources/project-websites/ufo-study/
Description
The UFO Study

Learn more about this trial

A Randomized Trial of Vaccine Adherence in Young Injection Drug Users

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