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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Behavioral: Incentive payment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment through a peer-based referral incentivization scheme | Recruitment numbers | 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 | 
| 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. | 6 months |