N/A
N=546
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
Medication Adherence · Substance Abuse, Intravenous · Risk Behavior · Hepatitis A · Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00244374 ↗Enrolled (actual)
546
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Vaccine Series Completion — 16; 20; 8; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hepatitis A & B vaccine (Biological); Outreach (Behavioral); AIC (Behavioral); SEP (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaccine Series Completion |
16; 20; 8; 10; 31; 23 | — |
| SECONDARY Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses |
20; 90; 11; 18 | — |
| SECONDARY Viral Transmission Risk Behavior Association With Travel |
83.7; 76.1; 55.7; 41.0; 56.5; 45.5 | 0.05 |
| SECONDARY HIV Vaccine Trial Willingness |
24; 68; 170; 147 | — |
| SECONDARY HIV Vaccine Trial Knowledge |
94; 315 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00244374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.