<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04428346</url>
  </required_header>
  <id_info>
    <org_study_id>VHCRP2004</org_study_id>
    <nct_id>NCT04428346</nct_id>
  </id_info>
  <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</brief_title>
  <acronym>AMPLIFY</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kirby Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kirby Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot two-arm, individual-level, randomised controlled trial to assess the effect of an&#xD;
      intervention integrating contingency management (financial incentives) to enhance hepatitis C&#xD;
      treatment uptake following dried blood spot hepatitis C RNA testing among people with recent&#xD;
      injecting drug use attending needle and syringe programs: the AMPLIFY study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of recruitment through a peer-based referral incentivization scheme</measure>
    <time_frame>6 months</time_frame>
    <description>Recruitment numbers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to HCV treatment initiation</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to HCV treatment completion</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of participants who enrolled in the study and where assigned treatment who commenced treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Contigency Management (Intervention)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incentive payment</intervention_name>
    <description>Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.</description>
    <arm_group_label>Contigency Management (Intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants have voluntarily signed the informed consent form&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. Recent injecting drug use (previous six months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Inability or unwillingness to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04428346
org study id: VHCRP2004
nct id: NCT04428346
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (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.
measure: The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing
time frame: 6 months
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.
measure: Feasibility of recruitment through a peer-based referral incentivization scheme
time frame: 6 months
description: Recruitment numbers
measure: Time to HCV treatment initiation
time frame: 6 months
measure: Time to HCV treatment completion
time frame: 6 months
measure: Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
time frame: 6 months
measure: Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
time frame: 6 months
measure: Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
time frame: 6 months
description: Proportion of participants who enrolled in the study and where assigned treatment who commenced treatment.
arm group label: Contigency Management (Intervention)
arm group type: Active Comparator
arm group label: Standard of Care (Control)
arm group type: No Intervention
intervention type: Behavioral
intervention name: Incentive payment
description: Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.
arm group label: Contigency Management (Intervention)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
sharing ipd: No