Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000436370
Ethics application status
Approved
Date submitted
25/07/2008
Date registered
29/08/2008
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Hepatitis B Acceptability and Vaccination Incentive Trial
Scientific 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.
Secondary ID [1] 262445 0
HAVIT
Universal Trial Number (UTN)
Trial acronym
HAVIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 3463 0
Condition category
Condition code
Public Health 3624 3624 0 0
Other public health
Inflammatory and Immune System 3625 3625 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a small financial incentives i.e. $30 will be given after the participant receives the second dose and $30 after the participant receives the third dose of Hepatitis B vaccine. Incentives will be given to participants randomised to the incentive arm only.
Intervention code [1] 3193 0
Prevention
Intervention code [2] 3261 0
Prevention
Comparator / control treatment
no financial incentive as per standard care
Control group
Active

Outcomes
Primary outcome [1] 4519 0
Determine relative to a standard care control condition the efficacy of incentive payments to increase Hepatitis B Vaccine (HBV) completion using an accelerated schedule (0, 7 and 21 days). Accelerated schedule i.e. receipt of all 3 Hepatitis B vaccinations in a shorter timeframe in comparison to the conventional schedule ( 0,1 and 6 months).
Timepoint [1] 4519 0
12 weeks
Secondary outcome [1] 7645 0
Assess the cost effectiveness of incentive payments relative to 'standard care' as a method of improving vaccine induced immunity as measured at 12 weeks and rates of successful series completion.The cost effectiveness analysis (CEA) will compare the marginal and incremental costs and outcomes of standard care with the incentive payment arm.
Timepoint [1] 7645 0
12 weeks
Secondary outcome [2] 7646 0
Identify the correlates of immunity(defined as hepatitis B surface antibody levels > =10mIU/ml at 12 weeks post intervention in this group.This will be assessed by blood analysis.
Timepoint [2] 7646 0
Baseline and week 12
Secondary outcome [3] 7647 0
Assess the acceptability of vaccines including HBV vaccines; barriers to immunisation uptake and willingness to participate in vaccine trials among people who inject drugs(PWID). All behavioural data will be collected using Audio Computer-Assisted Self Interview (ACASI) technology at baseline and at week 12 which has been associated with higher reports of sensitive and stigmatized behaviours among PWID, adolescents and HIV positive people (Des Jarlais et al. 1999; Metzger et al. 2000).
Timepoint [3] 7647 0
Baseline and week 12
Secondary outcome [4] 7648 0
Assess hepatitis B related knowledge in this group using the study-specific instrument (Day et al. 2003).
Timepoint [4] 7648 0
Baseline and week 12

Eligibility
Key inclusion criteria
1) Aged 16 years and above; 2) Injected drugs at least once in the preceding 6 months; 3) 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; 4) ability to provide informed consent, to be randomised and attend vaccinations over a period of 3 weeks and attend follow up at 12 weeks post randomisation.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Evidence of natural or vaccine induced immunity; 2) Previous exposure or two+ vaccinations (as identified by self report), where HBV surface antibody =10 mIU/ml; 3) Serious mental or physical illness or disability likely to impact on capacity to complete the study procedures; 4) Insufficient English language skills that will impair ability to give informed consent or provide reliable responses to study interviews/questionnaires; 5) Human Immunodeficiency Virus (HIV) infection; 6) Refusal to be vaccinated against hepatitis B.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed ( sealed envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: Statistical Analysis Software (SAS) implementation of randomisation will be used with RANUNI (the SAS command which creates random numbers from uniform distribution. It generates random numbers between 01 and 1) function.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1016 0
1340

Funding & Sponsors
Funding source category [1] 3647 0
Government body
Name [1] 3647 0
National Health and Medical Research Council (NHMRC)
Country [1] 3647 0
Australia
Primary sponsor type
Other
Name
The Kirby Institute (formerly the National Centre in HIV Epidemiology and Clinical Research)
Address
CFI Building
Corner Boundary and West Sts
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 3278 0
University
Name [1] 3278 0
University of New south Wales
Address [1] 3278 0
UNSW Sydney NSW 2052
Country [1] 3278 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5699 0
Royal Prince Alfred Ethics Committee
Ethics committee address [1] 5699 0
Ethics committee country [1] 5699 0
Australia
Date submitted for ethics approval [1] 5699 0
28/05/2008
Approval date [1] 5699 0
26/06/2008
Ethics approval number [1] 5699 0
08/RPAH/272

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28783 0
Address 28783 0
Country 28783 0
Phone 28783 0
Fax 28783 0
Email 28783 0
Contact person for public queries
Name 11940 0
Rachel Deacon
Address 11940 0
The Kirby Institute
CFI Building
Corner Boundary and West Sts
Darlinghurst NSW 2010
Country 11940 0
Australia
Phone 11940 0
02 9385 0935
Fax 11940 0
02 9385 0920
Email 11940 0
[email protected]
Contact person for scientific queries
Name 2868 0
Professor Lisa Maher
Address 2868 0
The Kirby Institute
CFI Building
Corner Boundary and West Sts
Darlinghurst NSW 2010
Country 2868 0
Australia
Phone 2868 0
02 9385 0936
Fax 2868 0
02 9385 0920
Email 2868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.