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Clinical Trials/NCT04428346
NCT04428346
Unknown
Not Applicable

A Pilot Two-arm, Individual-level, Randomised Controlled Trial to Assess the Effect of an Intervention Integrating Contingency Management (Financial Incentives) to Enhance Hepatitis C Treatment Uptake Following Dried Blood Spot Hepatitis C RNA Testing Among People With Recent Injecting Drug Use Attending Needle and Syringe Programs

Kirby Institute0 sites400 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatitis C, Chronic
Sponsor
Kirby Institute
Enrollment
400
Primary Endpoint
The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing
Last Updated
4 years ago

Overview

Brief Summary

A pilot two-arm, individual-level, randomised controlled trial to assess the effect of an intervention integrating contingency management (financial incentives) to enhance hepatitis C treatment uptake following dried blood spot hepatitis C RNA testing among people with recent injecting drug use attending needle and syringe programs: the AMPLIFY study

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
December 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants have voluntarily signed the informed consent form
  • 18 years of age or older
  • Recent injecting drug use (previous six months)

Exclusion Criteria

  • Inability or unwillingness to provide informed consent

Outcomes

Primary Outcomes

The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing

Time Frame: 6 months

Data will be presented in percentages and mean (SD) or median values (interquartile range), as appropriate. Chi square test or Fisher's exact test will be utilised, as appropriate, to examine between group differences.

Secondary Outcomes

  • Feasibility of recruitment through a peer-based referral incentivization scheme(6 months)
  • Time to HCV treatment initiation(6 months)
  • Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire(6 months)
  • Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake(6 months)
  • Time to HCV treatment completion(6 months)
  • Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)(6 months)

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