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)

April 13, 2022 updated by: Kirby Institute

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care (Control)
Active Comparator: Contigency Management (Intervention)
Behavioral: Incentive payment
Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment through a peer-based referral incentivization scheme
Time Frame: 6 months
Recruitment numbers
6 months
Time to HCV treatment initiation
Time Frame: 6 months
6 months
Time to HCV treatment completion
Time Frame: 6 months
6 months
Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
Time Frame: 6 months
6 months
Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
Time Frame: 6 months
6 months
Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
Time Frame: 6 months
Proportion of participants who enrolled in the study and where assigned treatment who commenced treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C, Chronic

Clinical Trials on Incentive payment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe