An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

Study Overview
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Brief Summary
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The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-treatment drug users. This study will also examine the effect of HBV vaccination coupled with community-based outreach intervention on reducing the incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk behaviors related to these viral transmissions. A secondary purpose will be to assess the antibody response after HBV vaccination as a measurement of immunological response in drug users.

Detailed Description
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This project will evaluate an HBV vaccination program as a model for future HIV vaccine efficacy trials in a community-based study of drug users. Two components will be analyzed in an effort to increase vaccine acceptance/adherence - behavioral intervention & an accelerated vaccine schedule. The study also will examine the effect of these variables on risk behaviors and incidence of HIV, HBV, & HCV infections. To accomplish these objectives, we propose a randomized behavioral intervention field trial. We will enroll 1600 current cocaine or heroin users negative for HBV & HIV markers from two closely matched, low-income, high drug endemic communities in Houston. All participants will be offered HBV vaccination and follow-up viral testing. One community will be randomly assigned to receive an outreach behavioral intervention designed to increase vaccine awareness and vaccine compliance. The other community will receive standard care. Participants electing to be vaccinated will be randomized to either a 0,1,6 month or a 0,1,2, month vaccine schedule. Groups will be followed for two years to determine rates of HBV vaccine acceptance/adherence to the 3-dose protocol. We also will measure any changes in risk behaviors & incidence of HIV/HBV/HCV infections as well as HBV vaccine immune response, if vaccinated. Drug users are the largest group of newly diagnosed HIV cases and so creating a model for an HIV vaccine's acceptance and adherence in this population is an important public health goal. This study will serve as a model for future HIV vaccine trials and will provide information on the effectiveness of outreach programs for increasing immunization among drug users. Unless an effective model based upon empirical experience is developed, any attempt to implement a HIV vaccination program among drug users is likely to be frustrated. If HBV vaccination coupled with outreach intervention can reduce risk behaviors and decrease the incidence of HIV/HCV infection, then this study will have a tremendous impact on the current HBV/HIV/HCV prevention strategy.

Official Title
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An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

Conditions
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Hepatitis B Infection, Hepatitis C Infection, HIV Infection

Intervention / Treatment
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* Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
* Behavioral: HBV Vaccination Self-Efficacy Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: using cocaine/heroin in last 7 days, age over 18 years old from two matched in population size, income and demographic communities, known with high rate of drug using and STD; competent to consent for urine drug screening and viral markers (anti-HIV, HBsAg/anti-HBs, anti-HCV) testing; those negative for HIV/HBV will be contacted for HB vaccination study. Exclusion Criteria: age under 18 or not from the target communities, negative for urine drug test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A1<br>standard behavioral intervention, standard HB vaccine schedule (0,1,6month) | |
| Active Comparator: A2<br>standard behavioral intervention, accelerated HB vaccine schedule (0,1,2month) | Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)<br>* hepatitis B (HB) vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated HB vaccine schedule (0,1,2 month),vs, standard HB vaccine schedule (0,1,6 m)<br>* Other names: accelerated HB vaccine schedule;|
| Active Comparator: B1<br>enhanced behavioral intervention, standard vaccine schedule | Behavioral: HBV Vaccination Self-Efficacy Intervention<br>* HB Vaccination Intervention consists of 4 sessions - Sessions 1, 2: at screening and enrollment after intake, vs regular risk reduction education Sessions 3, 4: coincide with the vaccination schedule ions 4 before 3rd dose<br>* Other names: enhanced behavioral intervention;|
| Active Comparator: B2<br>enhanced behavioral intervention, accelerated vaccine schedule (0,1,2MONTH) | Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)<br>* hepatitis B (HB) vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated HB vaccine schedule (0,1,2 month),vs, standard HB vaccine schedule (0,1,6 m)<br>* Other names: accelerated HB vaccine schedule;Behavioral: HBV Vaccination Self-Efficacy Intervention<br>* HB Vaccination Intervention consists of 4 sessions - Sessions 1, 2: at screening and enrollment after intake, vs regular risk reduction education Sessions 3, 4: coincide with the vaccination schedule ions 4 before 3rd dose<br>* Other names: enhanced behavioral intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance (adherence) for 3 doses hepatitis vaccination |  | Jan, 2004 - June 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of HIV and HCV infection and change of risk behaviors |  | Jan, 2004- June 2009 | 
| immunological response |  | Feb 2004 - June 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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druguser,HB vaccine adherence, HBV, HCV, HIV incidence