Hepatitis C, ChronicAMPLIFYNCT04428346
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
A study testing Incentive payment in people with Hepatitis C, Chronic, run by Kirby Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Incentive payment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants have voluntarily signed the informed consent form
- 18 years of age or older
- Recent injecting drug use (previous six months)
Who cannot join
- 1) Inability or unwillingness to provide informed consent
About this study
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
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
- Being tested
- Incentive payment
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive paymentBehavioural
Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.
| Study group | Role | What they receive |
|---|---|---|
| Contigency Management (Intervention) | Active comparator | Not described Receives: Behavioral: Incentive payment |
| Standard of Care (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Feasibility of recruitment through a peer-based referral incentivization scheme
Recruitment numbers
Measured: 6 months
Time to HCV treatment initiation
Measured: 6 months
Time to HCV treatment completion
Measured: 6 months
Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
Measured: 6 months
Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startOct 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428346
- Sponsor's protocol ID
- VHCRP2004
- Acronym
- AMPLIFY
- Status last verified
- Apr 2022
- First submitted
- 10 May 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04428346
- Acronym / sponsor ID
- AMPLIFY / VHCRP2004
- Conditions
- Hepatitis C, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contigency Management (Intervention) | Active comparator | Behavioral: Incentive payment |
| Standard of Care (Control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants have voluntarily signed the informed consent form
- 18 years of age or older
- Recent injecting drug use (previous six months)
Key exclusion criteria (1 listed)
- 1) Inability or unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive paymentIncentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs. | Behavioural | Contigency Management (Intervention) |
Primary outcome
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 secondary outcomes
Feasibility of recruitment through a peer-based referral incentivization scheme
Time frame: 6 months
Time to HCV treatment initiation
Time frame: 6 months
Time to HCV treatment completion
Time frame: 6 months
Time to visit to confirm viral cure (e.g. sustained virological response, SVR12)
Time frame: 6 months
Participant perceptions and acceptability of being involved in a contingency management study will be assessed by study questionnaire
Time frame: 6 months
Feasibility of a contingency management intervention to enhance hepatitis C treatment uptake
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive payment in people with Hepatitis C, Chronic, run by Kirby Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who initiate Hepatitis C Virus treatment within 12 weeks of testing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.