Clinical trial NCT00244374: A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
Official title: A Randomized Trial of Vaccine Adherence in Young IDU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Substance Abuse, Intravenous
Risk Behavior
Hepatitis A
Hepatitis B
Hepatitis C
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-10-26
Enrollment: 546
Sex: ALL
Minimum age (years): 14
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Vaccine Series Completion
timeFrame: 12 months
Secondary outcomes:
measure: Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
timeFrame: 12 months
measure: Viral Transmission Risk Behavior Association With Travel
timeFrame: Baseline
measure: HIV Vaccine Trial Willingness
timeFrame: Baseline
measure: HIV Vaccine Trial Knowledge
timeFrame: Baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Cen
state: California
Study officials:
affiliation: University of California, San Francisco
name: Paula J Lum, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.