An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2017 |
| Start Date: | January 2004 |
| End Date: | December 2009 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
