Hepatitis B Acceptability and Vaccination Incentive Trial

Hepatitis B Clinical Trial

— HAVIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744289
• Other study ID #: X08-0161
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: June 14, 2011
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Other:
• Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine

Locations

Country	Name	City	State
Australia	The Kirby Institute	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		12 weeks	No
Secondary	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		12 weeks	No
Secondary	Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml)		At baseline and week 12	No
Secondary	Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID		At baseline and week 12	No
Secondary	Assess hepatitis B-related knowledge in this group		At baseline and week 12	No