ANZCTR - Registration

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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]

HAVIT

Universal Trial Number (UTN)

Trial acronym

HAVIT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hepatitis B

Condition category

Condition code

Public Health

Other public health

Inflammatory and Immune System

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]

Prevention

Intervention code [2]

Prevention

Comparator / control treatment

no financial incentive as per standard care

Control group

Active

Outcomes

Primary outcome [1]

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]

12 weeks

Secondary outcome [1]

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]

12 weeks

Secondary outcome [2]

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]

Baseline and week 12

Secondary outcome [3]

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]

Baseline and week 12

Secondary outcome [4]

Assess hepatitis B related knowledge in this group using the study-specific instrument (Day et al. 2003).

Timepoint [4]

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]

1340

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO 1421 Canberra ACT 2601

Country [1]

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]

University

Name [1]

University of New south Wales

Address [1]

UNSW Sydney NSW 2052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Prince Alfred Ethics Committee

Ethics committee address [1]

Research Development Office
Level 8, Building 14
Royal Prince Alfred Hospital
Camperdown
NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/05/2008

Approval date [1]

26/06/2008

Ethics approval number [1]

08/RPAH/272

Summary

Brief summary

This trial seeks to investigate if  providing a small financial incentive ($30) will increase the uptake and completion of the hepatitis B vaccine among injecting drug users.

Trial website

Trial related presentations / publications

Publications:

Topp L, Day C, Dore G, Maher L. (2009). Poor criterion validity of self-reported hepatitis B infection and vaccination status among injecting drug users: A review. Drug and Alcohol Review 28(6): 669-675(7).

Conference presentations:

1. Deacon RM, Topp L, Wand H, Day CA, Rodgers C, Haber PS, van Beek I, Maher L on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group. Correlates of hepatitis B vaccination status among injecting drug users: a comparison of eligible and ineligible participants in the HAVIT trial. 7th Australasian Viral Hepatitis Conference, Melbourne: September 2010 (oral presentation).  

2. Deacon R, Day C, Topp L, Rodgers C, Wand H, Shanahan M, van Beek I, Haber P, Maher L on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group. Using financial incentives to increase hepatitis B immunisation completion in people who inject drugs: A randomised controlled trial. Australasian Professional Society on Alcohol and other Drugs Conference, Darwin: November 2009, Drug and Alcohol Review 28(s1): abstract 247:A13.

3. Deacon R, Day C, Topp L, Rodgers C, Wand H, Shanahan M, van Beek I, Haber P, Maher L on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group. Using financial incentives to increase hepatitis B immunisation completion in people who inject drugs: A randomised controlled trial. Australasian Professional Society on Alcohol and other Drugs Conference, Darwin: November 2009 (oral presentation).

4. Barnes K, van Beek I, Day C, Topp L, Shanahan M, Wand H, Maher L (on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group). Using financial incentives to increase hepatitis B immunisation completion in injecting drug users. Australasian Professional Society on Alcohol and other Drugs: Drug and Alcohol Conference, Sydney: November 2008 (poster presentation).

5. Barnes K, van Beek I, Day C, Topp L, Shanahan M, Wand H, Maher L (on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group). Using financial incentives to increase hepatitis B immunisation completion in injecting drug users: A randomised controlled trial. Australian Society of HIV Medicine Annual Meeting, Perth: October 2008 (oral presentation). 

6. Maher L, Barnes K, van Beek I, Day C, Topp L, Shanahan M, Wand H (on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group) Increasing hepatitis B immunisation completion in people who inject drug. 6th Australasian Viral Hepatitis Conference, Brisbane: October 2008 (oral presentation). 

7. Maher L, Barnes K, Topp L, Day C (on behalf of the Hepatitis Acceptability and Vaccine Incentives Trial (HAVIT) Group). Use of incentives to increase vaccination uptake and completion in injecting drug users. 11th National Immunisation Conference, Gold Coast: September 2008 (oral presentation).

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Rachel Deacon

Address

The Kirby Institute
CFI Building
Corner Boundary and West Sts
Darlinghurst NSW 2010

Country

Australia

Phone

02 9385 0935

Fax

02 9385 0920

rdeacon@kirby.unsw.edu.au

Contact person for scientific queries

Name

Professor Lisa Maher

Address

The Kirby Institute
CFI Building
Corner Boundary and West Sts
Darlinghurst NSW 2010

Country

Australia

Phone

02 9385 0936

Fax

02 9385 0920

lmaher@kirby.unsw.edu.au

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

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No additional documents have been identified.

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