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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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00744289