NCT00744289

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

2.7 years

First QC Date

August 26, 2008

Last Update Submit

June 14, 2011

Conditions

Hepatitis B

Keywords

Hepatitis BPeople who inject drugsFinancial incentiveVaccine completion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml)

    At baseline and week 12

  • 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

  • Assess hepatitis B-related knowledge in this group

    At baseline and week 12

Study Arms (2)

Arm 1

NO INTERVENTION

Participants in Arm 1 will not receive any financial incentive after the second and third dose of hepatitis B vaccine have been administered.

Arm 2

OTHER

Participants in Arm 2 will receive a small financial incentive after the second and third dose of the hepatitis B vaccine

Other: Incentive condition

Interventions

Incentive conditionOTHER

Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine

Arm 2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kirby Institute

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Lisa Maher, PhD

    Kirby Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 29, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

AU(1)