Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT)

June 14, 2011 updated by: Kirby Institute

A Randomised Controlled Trial to Evaluate the Effectiveness of a Small Financial Incentive After the Second and Third Dose of a Hepatitis B Vaccine, on Vaccine Completion in People Who Inject Drugs

Aims:

This prospective trial seeks to investigate the efficacy of a financial incentive in increasing the uptake and completion of the HBV vaccine series among people who inject drugs (PWID). Using a randomised controlled trial design, the investigators will offer the 3 dose, accelerated HBV schedule to eligible PWID allocated to either a standard of care or incentive condition. Participants allocated to the incentive condition will receive a small incentive payment after the second and third dose of the vaccine. It is hypothesized that the proportion of participants who complete the vaccine series in the incentive payment arm will be higher compared to the non-incentive payment arm (standard of care).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Injecting drug use is the leading exposure category for notifications of newly acquired hepatitis B virus (HBV) infection in Australia. Despite the existence of a safe and efficacious vaccine, hepatitis B coverage remains low among Australian people who inject drugs (PWID) and little is known about attitudes to immunisation, barriers to uptake and willingness to participate in vaccine trials among this group. Candidate vaccines for hepatitis C virus (HCV) and HIV are currently in development and HBV immunisation provides a surrogate for examining strategies to deliver vaccines to this group.

Secondary objectives of this trial are to (i) assess the cost effectiveness of the interventions; (ii) identify the correlates of immunity in this group; (iii) assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID; and (iv) assess hepatitis B-related knowledge in this group.

Research Design: A total of 200 eligible PWID or people at risk of initiating injecting (those with no history of exposure to or receipt of more than one vaccination against HBV) will be recruited and interviewed prior to randomisation on a 1:1 basis (100 per arm) to either the (1) control (standard of care) or (2) incentive conditions. All participants will be offered the 3 dose accelerated vaccine schedule (20ug at 0, 7 and 21 days) and will be followed up at week 12.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • The Kirby Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 16 years and above.
  • Injected drugs at least once in the preceding six months, OR (i) Use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, AND (ii) Spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
  • No previous hepatitis B infection, and a maximum of one previous dose of hepatitis B vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
  • Ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.

Exclusion Criteria:

  • Evidence of natural or vaccine-induced immunity.
  • Previous exposure or two+ vaccinations (as identified by self-report), where HBV surface antibody >= 10 mIU/ml
  • Serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
  • Insufficient English language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
  • Human Immunodeficiency Virus infection
  • Refusal to be vaccinated against Hepatitis B Virus (HBV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 1
Participants in Arm 1 will not receive any financial incentive after the second and third dose of hepatitis B vaccine have been administered.
Other: Arm 2
Participants in Arm 2 will receive a small financial incentive after the second and third dose of the hepatitis B vaccine
Other: Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine, relative to a 'standard of care' control condition, the efficacy of incentive payments to increase HBV vaccine completion using an accelerated schedule (0, 7, and 21 days).
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the relative cost effectiveness of standard care compared to incentive payments as methods of improving rates of successful vaccine series completion and vaccine-induced immunity
Time Frame: 12 weeks
12 weeks
Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml)
Time Frame: At baseline and week 12
At baseline and week 12
Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID
Time Frame: At baseline and week 12
At baseline and week 12
Assess hepatitis B-related knowledge in this group
Time Frame: At baseline and week 12
At baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Lisa Maher, PhD, Kirby Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X08-0161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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