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A 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 (AMPLIFY)

Primary Purpose

Hepatitis C, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incentive payment
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participants have voluntarily signed the informed consent form
  2. 18 years of age or older
  3. Recent injecting drug use (previous six months)

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Contigency Management (Intervention)

    Standard of Care (Control)

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Feasibility of recruitment through a peer-based referral incentivization scheme
    Recruitment numbers
    Time to HCV treatment initiation
    Time to HCV treatment completion
    Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
    Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
    Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
    Proportion of participants who enrolled in the study and where assigned treatment who commenced treatment.

    Full Information

    First Posted
    May 10, 2020
    Last Updated
    April 13, 2022
    Sponsor
    Kirby Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04428346
    Brief Title
    A 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
    Acronym
    AMPLIFY
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kirby Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    Participants will be randomised with a computerised random number generator (or random number table) with block randomisation to assist with keeping participant balance between study arms with a small sample size.
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Contigency Management (Intervention)
    Arm Type
    Active Comparator
    Arm Title
    Standard of Care (Control)
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Incentive payment
    Intervention Description
    Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.
    Primary Outcome Measure Information:
    Title
    The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Feasibility of recruitment through a peer-based referral incentivization scheme
    Description
    Recruitment numbers
    Time Frame
    6 months
    Title
    Time to HCV treatment initiation
    Time Frame
    6 months
    Title
    Time to HCV treatment completion
    Time Frame
    6 months
    Title
    Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
    Time Frame
    6 months
    Title
    Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
    Time Frame
    6 months
    Title
    Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
    Description
    Proportion of participants who enrolled in the study and where assigned treatment who commenced treatment.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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: 1) Inability or unwillingness to provide informed consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A 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

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