Trial Outcomes & Findings for A Randomized Trial of Vaccine Adherence in Young Injection Drug Users (NCT NCT00244374)
NCT ID: NCT00244374
Last Updated: 2013-09-30
Results Overview
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
COMPLETED
NA
546 participants
12 months
2013-09-30
Participant Flow
Between 08/31/2004 and 11/30/2007, street-based outreach workers distributed study invitation cards to potential subjects in neighborhoods of San Francisco where young injection drug users (IDU) are known to congregate. Initial Contact form included self-reported age, IDU in last 30 days, hepatitis B immunization and HIV-positive status.
1304 persons completed initial contact form; 645 were eligible and 546 opted to participate in the cross-sectional study. The vaccine adherence cohort (n=167) included participants enrolled prior to 3/31/2007 who met additional eligibility criteria.
Participant milestones
| Measure |
Cross-sectional/Screening
Cross-sectional screening to determine eligibility for vaccine adherence trial
|
AIC Only
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|---|
|
Pre-Randomization Cross-sectional Study
STARTED
|
546
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Cross-sectional Study
COMPLETED
|
409
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Cross-sectional Study
NOT COMPLETED
|
137
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
STARTED
|
440
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Eligible for Vaccine Adherence Cohort
|
217
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
COMPLETED
|
167
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
NOT COMPLETED
|
273
|
0
|
0
|
0
|
0
|
|
Vaccine Adherence Cohort
STARTED
|
0
|
47
|
43
|
36
|
41
|
|
Vaccine Adherence Cohort
COMPLETED
|
0
|
47
|
43
|
36
|
41
|
|
Vaccine Adherence Cohort
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cross-sectional/Screening
Cross-sectional screening to determine eligibility for vaccine adherence trial
|
AIC Only
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|---|
|
Pre-Randomization Cross-sectional Study
Did not complete baseline procedures
|
105
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Cross-sectional Study
Technical difficulty loss of data
|
17
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Cross-sectional Study
Did not respond to willingness questions
|
14
|
0
|
0
|
0
|
0
|
|
Pre-Randomization Cross-sectional Study
Interviewer lack confidence in responses
|
1
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Evidence of hepatitis B immunization
|
172
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Unable/unwilling to complete enrollment
|
51
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Did not return for screening test result
|
34
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Returned for results after enroll window
|
4
|
0
|
0
|
0
|
0
|
|
Evaluation for Vaccine Adherence Cohort
Declined to participate in cohort
|
12
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
Baseline characteristics by cohort
| Measure |
All Participants
n=546 Participants
Participants in pre-randomization cross-sectional study
|
|---|---|
|
Age, Customized
Age 0 - 14 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age 15 - 29 years
|
546 Participants
n=5 Participants
|
|
Age, Customized
Age >= 30 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
149 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
395 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown/Other/Not Reported
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
460 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
392 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
546 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary outcome was the completion of the four-dose vaccine series in a 12 month period.
Outcome measures
| Measure |
AIC Only
n=47 Participants
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
n=43 Participants
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
n=36 Participants
Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
|
SEP + Outreach
n=41 Participants
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
|
|---|---|---|---|---|
|
Vaccine Series Completion
Completed <4 vaccine doses
|
31 participants
|
23 participants
|
28 participants
|
31 participants
|
|
Vaccine Series Completion
Completed 4 vaccine doses
|
16 participants
|
20 participants
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 139 participants who completed 3 vaccine doses were included in the analysis. Enrollment for this aim continued after enrollment into the 12-month vaccine adherence trial closed; an additional 51 persons were found eligible and enrolled.
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.
Outcome measures
| Measure |
AIC Only
n=31 Participants
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
n=108 Participants
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|
|
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
anti-HBs positive
|
20 Participants
|
90 Participants
|
—
|
—
|
|
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses
anti-HBs negative
|
11 Participants
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006
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.
Outcome measures
| Measure |
AIC Only
n=221 Participants
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
n=134 Participants
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|
|
Viral Transmission Risk Behavior Association With Travel
Used (injected/snorted/smoked) crack cocaine
|
56.5 percentage of participants
|
45.5 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Used (injected/snorted/smoked) methamphetamine
|
67.4 percentage of participants
|
78.4 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Injected daily, past 30 days
|
23.5 percentage of participants
|
33.6 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Number of injecting partners >=5
|
59.7 percentage of participants
|
41.1 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Used (injected/snorted/smoked) heroin
|
83.7 percentage of participants
|
76.1 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Used (injected/snorted/smoked) powder cocaine
|
55.7 percentage of participants
|
41.0 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
More than one of the above (poly-substance use)
|
87.2 percentage of participants
|
76.3 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Heavy drinking (>14, >21 per week; women, men)
|
52.3 percentage of participants
|
13.7 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Drank until blacked out
|
36.8 percentage of participants
|
13.7 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Lent a needle/syringe
|
53.3 percentage of participants
|
46.3 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Injected with someone else's used needle/syringe
|
52.3 percentage of participants
|
37.8 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Pooled money to buy drugs
|
86.4 percentage of participants
|
66.2 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Shared cooker/spoon to prepare drugs
|
67.0 percentage of participants
|
48.1 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Syringe was backloaded
|
62.7 percentage of participants
|
47.4 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Did someone's "rinse"
|
42.5 percentage of participants
|
34.3 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Median number of sexual partners >=2
|
58.4 percentage of participants
|
38.1 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
Traded sex for money or drugs
|
11.3 percentage of participants
|
11.9 percentage of participants
|
—
|
—
|
|
Viral Transmission Risk Behavior Association With Travel
>90% condom use if sexually active
|
24.3 percentage of participants
|
22.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data
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).
Outcome measures
| Measure |
AIC Only
n=409 Participants
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|
|
HIV Vaccine Trial Willingness
4=Definitely willing
|
147 Participants
|
—
|
—
|
—
|
|
HIV Vaccine Trial Willingness
1=Definitely not willing
|
24 Participants
|
—
|
—
|
—
|
|
HIV Vaccine Trial Willingness
2=Probably not willing
|
68 Participants
|
—
|
—
|
—
|
|
HIV Vaccine Trial Willingness
3=Probably willing
|
170 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data
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). 1. Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative. 2. Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance). 3. Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies. 4. Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe. 5. Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies. 6. HIV vaccines will never affect a person's HIV test results. 7. An HIV vaccine can infect a person with HIV disease. 8. People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects.
Outcome measures
| Measure |
AIC Only
n=409 Participants
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.
|
SEP + Outreach
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
|
|---|---|---|---|---|
|
HIV Vaccine Trial Knowledge
5-8 Correct answers
|
94 Participants
|
—
|
—
|
—
|
|
HIV Vaccine Trial Knowledge
0-4 Correct answers
|
315 Participants
|
—
|
—
|
—
|
Adverse Events
AIC Only
AIC + Outreach
SEP Only
SEP + Outreach
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paula J. Lum
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place