Medication AdherenceUFO VAXNCT00244374
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
A study testing Hepatitis A & B vaccine, Outreach and AIC in people with Medication Adherence and Substance Abuse, Intravenous, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 29 years
- Conditions the study is for
- Medication Adherence, Substance Abuse, Intravenous, Risk Behavior
- What is being tested?
- Hepatitis A & B vaccine, Outreach and AIC
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 14-29 at screening
- injected drugs in the prior 30 days
- 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
Who cannot join
- Prior positive HIV antibody test
- Prior HBV immunization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Medical Cen
San Francisco, California, 94143 0939
About this study
Official title: A Randomized Trial of Vaccine Adherence in Young IDU
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.
Read the 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.
- Conditions
- Medication Adherence, Substance Abuse, Intravenous, Risk Behavior, Hepatitis A, Hepatitis B, Hepatitis C
- Being tested
- Hepatitis A & B vaccine, Outreach, AIC, SEP
- Medical subject headings
- Medication Adherence, Substance Abuse, Intravenous, Risk-Taking, Hepatitis A, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A & B vaccineBiological
Also called Twinrix, Engerix-B
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.
OutreachBehavioural
Also called Haight Ashbury Youth Outreach Team (HAYOT), Glide Health Services
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.
AICBehavioural
Also called Adult Immunization Clinic (AIC), San Francisco Department of Public Health (SFDPH)
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.
SEPBehavioural
Also called syringe exchange, needle exchange, harm reduction, San Francisco Needle Exchange (SFNE)
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.
| Study group | Role | What they receive |
|---|---|---|
| AIC, Hepatitis A & B vaccine | Experimental | Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6. Receives: Biological: Hepatitis A & B vaccine; Behavioral: AIC |
| AIC, Outreach, Hepatitis A & B vaccine | Experimental | 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 Receives: Biological: Hepatitis A & B vaccine; Behavioral: Outreach; Behavioral: AIC |
| SEP, Hepatitis A & B vaccine | Experimental | SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Receives: Biological: Hepatitis A & B vaccine; Behavioral: SEP |
| SEP, Outreach, Hepatitis A & B vaccine | Experimental | 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 Receives: Biological: Hepatitis A & B vaccine; Behavioral: Outreach; Behavioral: SEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Series Completion
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Paula J Lum, M.D., M.P.H., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244374
- Sponsor's protocol ID
- NIDA-17476-1
- Other IDs
- R01DA017476
- Acronym
- UFO VAX
- Status last verified
- Jul 2013
- First submitted
- 25 Oct 2005
- Last updated
- 30 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17980513Etcheverry 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.
PubMed 21241735Lum 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.
PubMed 18233994
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Vaccine Adherence in Young IDU
- ClinicalTrials.gov ID
- NCT00244374
- Acronym / sponsor ID
- UFO VAX / NIDA-17476-1
- Conditions
- Medication Adherence, Substance Abuse, Intravenous, Risk Behavior, Hepatitis A, Hepatitis B, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 Oct 2005 (estimated)
- Results
- Posted 19 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AIC, Hepatitis A & B vaccine | Experimental | Biological: Hepatitis A & B vaccine, Behavioral: AICSubjects 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 | Experimental | Biological: Hepatitis A & B vaccine, Behavioral: Outreach, Behavioral: AICAIC + 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 | Experimental | Biological: Hepatitis A & B vaccine, Behavioral: SEPSEP 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 | Experimental | Biological: Hepatitis A & B vaccine, Behavioral: Outreach, Behavioral: SEPSubjects 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 |
Who may qualify
- Ages
- 14 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age 14-29 at screening
- injected drugs in the prior 30 days
- 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
Key exclusion criteria (2 listed)
- Prior positive HIV antibody test
- Prior HBV immunization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis A & B vaccineAlso: Twinrix, Engerix-BEach 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. | Biological | AIC, Hepatitis A & B vaccine, AIC, Outreach, Hepatitis A & B vaccine, SEP, Hepatitis A & B vaccine, SEP, Outreach, Hepatitis A & B vaccine |
| OutreachAlso: Haight Ashbury Youth Outreach Team (HAYOT), Glide Health ServicesOutreach 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. | Behavioural | AIC, Outreach, Hepatitis A & B vaccine, SEP, Outreach, Hepatitis A & B vaccine |
| AICAlso: Adult Immunization Clinic (AIC), San Francisco Department of Public Health (SFDPH)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. | Behavioural | AIC, Hepatitis A & B vaccine, AIC, Outreach, Hepatitis A & B vaccine |
| SEPAlso: syringe exchange, needle exchange, harm reduction, San Francisco Needle Exchange (SFNE)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. | Behavioural | SEP, Hepatitis A & B vaccine, SEP, Outreach, Hepatitis A & B vaccine |
Primary outcome
Vaccine Series Completion
Time frame: 12 months
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
4 secondary outcomes
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
Time frame: 12 months
Viral Transmission Risk Behavior Association With Travel
Time frame: Baseline
HIV Vaccine Trial Willingness
Time frame: Baseline
HIV Vaccine Trial Knowledge
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17980513Hahn 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 publication: PubMed 21241735Etcheverry 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 publication: PubMed 18233994Lum 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.
- The UFO StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula J Lum, M.D., M.P.H. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis A & B vaccine, Outreach and AIC in people with Medication Adherence and Substance Abuse, Intravenous, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Series Completion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244374, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.