Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00744289




Registration number
NCT00744289
Ethics application status
Date submitted
26/08/2008
Date registered
29/08/2008
Date last updated
16/06/2011

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] 0 0
X08-0161
Universal Trial Number (UTN)
Trial acronym
HAVIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Incentive condition

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 interventions: Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml)
Timepoint [2] 0 0
At baseline and week 12
Secondary outcome [3] 0 0
Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID
Timepoint [3] 0 0
At baseline and week 12
Secondary outcome [4] 0 0
Assess hepatitis B-related knowledge in this group
Timepoint [4] 0 0
At baseline and week 12

Eligibility
Key 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.
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.
* 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Kirby Institute - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT00744289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Maher, PhD
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00744289