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

NCT04428346 | Unknown

• 1 other identifier: VHCRP2004
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Feasibility of recruitment through a peer-based referral incentivization scheme

  6 months

• Time to HCV treatment initiation

  6 months

• Time to HCV treatment completion

  6 months

• Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)

  6 months

• Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire

  6 months

Study Arms (2)

Contigency Management (Intervention)

ACTIVE COMPARATOR

Behavioral: Incentive payment

Standard of Care (Control)

NO INTERVENTION

Interventions

Incentive payment BEHAVIORAL

Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.

Contigency Management (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Kirby Institute: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: June 11, 2020
• Study Start: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share