Medication Adherence, Substance Abuse, Intravenous, Risk Behavior, Hepatitis A, Hepatitis B, Hepatitis C
Conditions
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.
Interventions
BIOLOGICALHepatitis A & B vaccine
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.
BEHAVIORALOutreach
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.
BEHAVIORALAIC
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.
BEHAVIORALSEP
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Series Completion | 12 months | The primary outcome was the completion of the four-dose vaccine series in a 12 month period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Vaccine Trial Willingness | Baseline | 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 | Baseline | 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. |
| Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses | 12 months | 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 | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants in pre-randomization cross-sectional study | 546 |
| Total | 546 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Evaluation for Vaccine Adherence Cohort | Declined to participate in cohort | 12 | 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 | Evidence of hepatitis B immunization | 172 | 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 | Unable/unwilling to complete enrollment | 51 | 0 | 0 | 0 | 0 |
| Pre-Randomization Cross-sectional Study | Did not complete baseline procedures | 105 | 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 |
| Pre-Randomization Cross-sectional Study | Technical difficulty loss of data | 17 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized Age 0 - 14 years | 0 Participants |
| Age, Customized Age 15 - 29 years | 546 Participants |
| Age, Customized Age >= 30 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 460 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 63 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 61 Participants |
| Race (NIH/OMB) White | 392 Participants |
| Region of Enrollment United States | 546 participants |
| Sex/Gender, Customized Female | 149 Participants |
| Sex/Gender, Customized Male | 395 Participants |
| Sex/Gender, Customized Unknown/Other/Not Reported | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 43 | 0 / 36 | 0 / 41 |
| serious Total, serious adverse events | 0 / 47 | 0 / 43 | 0 / 36 | 0 / 41 |
Outcome results
Primary
Vaccine Series Completion
The primary outcome was the completion of the four-dose vaccine series in a 12 month period.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIC Only | Vaccine Series Completion | Completed <4 vaccine doses | 31 participants |
| AIC Only | Vaccine Series Completion | Completed 4 vaccine doses | 16 participants |
| AIC + Outreach | Vaccine Series Completion | Completed 4 vaccine doses | 20 participants |
| AIC + Outreach | Vaccine Series Completion | Completed <4 vaccine doses | 23 participants |
| SEP Only | Vaccine Series Completion | Completed 4 vaccine doses | 8 participants |
| SEP Only | Vaccine Series Completion | Completed <4 vaccine doses | 28 participants |
| SEP + Outreach | Vaccine Series Completion | Completed <4 vaccine doses | 31 participants |
| SEP + Outreach | Vaccine Series Completion | Completed 4 vaccine doses | 10 participants |
Secondary
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIC Only | Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses | anti-HBs positive | 20 Participants |
| AIC Only | Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses | anti-HBs negative | 11 Participants |
| AIC + Outreach | Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses | anti-HBs positive | 90 Participants |
| AIC + Outreach | Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses | anti-HBs negative | 18 Participants |
Secondary
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). 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.
Time frame: Baseline
Population: Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIC Only | HIV Vaccine Trial Knowledge | 5-8 Correct answers | 94 Participants |
| AIC Only | HIV Vaccine Trial Knowledge | 0-4 Correct answers | 315 Participants |
Secondary
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).
Time frame: Baseline
Population: Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIC Only | HIV Vaccine Trial Willingness | 1=Definitely not willing | 24 Participants |
| AIC Only | HIV Vaccine Trial Willingness | 2=Probably not willing | 68 Participants |
| AIC Only | HIV Vaccine Trial Willingness | 3=Probably willing | 170 Participants |
| AIC Only | HIV Vaccine Trial Willingness | 4=Definitely willing | 147 Participants |
Secondary
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.
Time frame: Baseline
Population: Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) heroin | 83.7 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) powder cocaine | 55.7 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) crack cocaine | 56.5 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) methamphetamine | 67.4 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | More than one of the above (poly-substance use) | 87.2 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Heavy drinking (>14, >21 per week; women, men) | 52.3 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Drank until blacked out | 36.8 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Injected daily, past 30 days | 23.5 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Number of injecting partners >=5 | 59.7 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Lent a needle/syringe | 53.3 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Injected with someone else's used needle/syringe | 52.3 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Pooled money to buy drugs | 86.4 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Shared cooker/spoon to prepare drugs | 67.0 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Syringe was backloaded | 62.7 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Did someone's rinse | 42.5 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Median number of sexual partners >=2 | 58.4 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | Traded sex for money or drugs | 11.3 percentage of participants |
| AIC Only | Viral Transmission Risk Behavior Association With Travel | >90% condom use if sexually active | 24.3 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Syringe was backloaded | 47.4 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) heroin | 76.1 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Lent a needle/syringe | 46.3 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) powder cocaine | 41.0 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | >90% condom use if sexually active | 22.5 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) crack cocaine | 45.5 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Injected with someone else's used needle/syringe | 37.8 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Used (injected/snorted/smoked) methamphetamine | 78.4 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Did someone's rinse | 34.3 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | More than one of the above (poly-substance use) | 76.3 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Pooled money to buy drugs | 66.2 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Heavy drinking (>14, >21 per week; women, men) | 13.7 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Traded sex for money or drugs | 11.9 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Drank until blacked out | 13.7 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Shared cooker/spoon to prepare drugs | 48.1 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Injected daily, past 30 days | 33.6 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Median number of sexual partners >=2 | 38.1 percentage of participants |
| AIC + Outreach | Viral Transmission Risk Behavior Association With Travel | Number of injecting partners >=5 | 41.1 percentage of participants |
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: 0.0595% CI: [0.8, 2.44]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: 0.0195% CI: [1.12, 2.76]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: 0.0395% CI: [0.35, 0.98]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: <0.0195% CI: [1.11, 3.59]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: 0.0595% CI: [1, 2.44]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: <0.0195% CI: [3.84, 12.28]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: <0.0195% CI: [2.02, 6.5]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: 0.0495% CI: [0.33, 0.93]Regression, Logistic
Comparison: Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.p-value: <0.0195% CI: [1.37, 3.4]Regression, Logistic
Comparison: Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 daysp-value: 0.1995% CI: [0.81, 1.97]Regression, Logistic
Comparison: Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 daysp-value: <0.0195% CI: [1.01, 2.55]Regression, Logistic
Comparison: Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 daysp-value: <0.0195% CI: [1.79, 5.27]Regression, Logistic
Comparison: Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviorsp-value: <0.0195% CI: [1.34, 3.32]Regression, Logistic
Comparison: Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviorsp-value: <0.0195% CI: [1.19, 2.95]Regression, Logistic
Comparison: Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 daysp-value: 0.1395% CI: [0.83, 2.1]Regression, Logistic
Comparison: Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 daysp-value: <0.0195% CI: [1.4, 3.49]Regression, Logistic
Comparison: Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 daysp-value: 0.8695% CI: [0.45, 1.85]Regression, Logistic
Comparison: Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 daysp-value: 0.7395% CI: [0.59, 2.02]Regression, Logistic