HCVSHIMNCT07569211
Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine
A study testing Simplified HCV Integrated Management, Pay-for-performance and Case Management and Referral in people with HCV and Opioid Use Disorder, run by Ukrainian Institute on Public Health Policy at 1 site in Ukraine.
Trial summary
The goal of this pragmatic, quasi-experimental cluster trial is to evaluate whether simplified, onsite hepatitis C virus (HCV) treatment integrated into opioid agonist maintenance therapy (OAMT) clinics improves cure rates compared with referral-based care in Ukraine . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV, Opioid Use Disorder
- What is being tested?
- Simplified HCV Integrated Management, Pay-for-performance and Case Management and Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteUkraine
- Study dates
- 4 Mar 2023to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently receiving treatment at the selected OAT site (implying a diagnosis of opioid dependence according to ICD 10);
- aged 18 years or older;
- residing within the study catchment area; and
- having a positive HCV antibody test documented in the medical chart
Who cannot join
- previous HCV treatment history;
- active tuberculosis (assessed using 4-item screening questionnaire and confirmed according to the current national protocol);
- pregnant or planning pregnancy in the next 6 months;
- planning to move to another city in the next 6 months;
- unwillingness to undergo confirmatory HCV RNA PCR test at their own expense and treat HCV
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pragmatic, quasi-experimental cluster trial is to evaluate whether simplified, onsite hepatitis C virus (HCV) treatment integrated into opioid agonist maintenance therapy (OAMT) clinics improves cure rates compared with referral-based care in Ukraine . The study includes adults (18 years and older) receiving OAMT with confirmed chronic HCV infection and no prior HCV treatment.
The main questions it aims to answer are:
Read more
- Does onsite Simplified HCV Integrated Management (SHIM) increase the proportion of patients achieving sustained virologic response 12 weeks after treatment completion (SVR12) compared with case management and referral (CMR) to specialist clinics?
- Does adding provider pay-for-performance (P4P) incentives to SHIM further improve progression along the HCV treatment cascade and SVR12 rates?
Researchers compared three models of care across 13 OAMT clinics in 12 Ukrainian cities:
- Case Management and Referral (CMR): structured referral to off-site specialist clinics for HCV treatment
- SHIM: simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
- SHIM + P4P: SHIM with provider incentives linked to completion of key cascade milestones All SHIM clinics were supported by Project ECHO telementoring to strengthen clinician capacity . The study used nationally procured direct-acting antivirals (DAAs) under routine program conditions and did not reimburse diagnostic costs.
Between February 2023 and December 2024, 616 eligible patients were enrolled .
Participants:
- Completed confirmatory HCV RNA testing
- Underwent simplified pretreatment clinical and laboratory assessment
- Received 12 weeks of pan-genotypic DAA treatment either onsite (SHIM arms) or at specialist clinics (CMR arm)
- Attended follow-up visits during treatment for adherence assessment and counseling
- Were prescribed HCV RNA testing 12 weeks after treatment completion to confirm cure (SVR12) The primary outcome was SVR12. Secondary outcomes included completion of pretreatment evaluation, treatment initiation, treatment completion, and completion of SVR assessment.
This study evaluates HCV care under real-world conditions during ongoing national treatment scale-up in Ukraine. The findings inform whether integrating simplified HCV treatment into OAMT clinics-and aligning provider incentives-can improve cure rates and accelerate progress toward HCV elimination in high-burden populations.
- Conditions
- HCV, Opioid Use Disorder
- Being tested
- Simplified HCV Integrated Management, Pay-for-performance, Case Management and Referral
- Keywords
- implementation science, Ukraine, Eastern Europe, Hepatitis C, HCV treatment cascade, Opioid agonist maintenance therapy
- Medical subject headings
- Opioid-Related Disorders, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified HCV Integrated ManagementOther
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
Pay-for-performanceOther
provider incentives linked to completion of key cascade milestones
Case Management and ReferralOther
structured referral to off-site specialist clinics for HCV treatment
| Study group | Role | What they receive |
|---|---|---|
| Case Management and Referral | Active comparator | structured referral to off-site specialist clinics for HCV treatment Receives: Other: Case Management and Referral |
| Simplified HCV Integrated Management | Experimental | simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians Receives: Other: Simplified HCV Integrated Management |
| Simplified HCV Integrated Management + Pay-for-performance | Experimental | simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones Receives: Other: Simplified HCV Integrated Management; Other: Pay-for-performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response
Number of participants who have HCV RNA below the limit of quantitation (≤50 IU/mL) based on clinical records
Measured: Up to 24 weeks after treatment completion
Secondary outcomes (5)
Completion of all pretreatment diagnostic assessments
Number of participants who complete all pretreatment diagnostic assessments according to the SHIM algorithm (complete blood count, basic metabolic panel (including creatinine), hepatic function panel, fibrosis assessment, and HBsAg testing) based on clinical records
Measured: Through study completion, an average of 2 weeks after baseline
Treatment initiation
Number of participants who are prescribed treatment for HCV infection based on clinical records
Measured: Through study completion, an average of 4 weeks after baseline
Treatment completion
Number of participants who complete the full course of HCV treatment as prescribed based on clinical records
Measured: Through study completion, an average of 14 weeks after baseline
SVR assessment completion
Number of participants who complete HCV RNA testing for SVR confirmation based on clinical records
Measured: Up to 24 weeks after treatment completion
HCV reinfection
Number of participants who receive a positive result of HCV RNA test at 12 months after treatment completion, based on clinical records
Measured: 12 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start4 Mar 2023
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Institute on Public Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569211
- Sponsor's protocol ID
- 127-2022
- Acronym
- SHIM
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine
- ClinicalTrials.gov ID
- NCT07569211
- Acronym / sponsor ID
- SHIM / 127-2022
- Conditions
- HCV, Opioid Use Disorder
- Keywords
- implementation science, Ukraine, Eastern Europe, Hepatitis C, HCV treatment cascade, Opioid agonist maintenance therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- Ukrainian Institute on Public Health PolicyUniversity, hospital or other
- Collaborators
- The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 May 2026 (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.
The goal of this pragmatic, quasi-experimental cluster trial is to evaluate whether simplified, onsite hepatitis C virus (HCV) treatment integrated into opioid agonist maintenance therapy (OAMT) clinics improves cure rates compared with referral-based care in Ukraine . The study includes adults (18 years and older) receiving OAMT with confirmed chronic HCV infection and no prior HCV treatment.
The main questions it aims to answer are:
- Does onsite Simplified HCV Integrated Management (SHIM) increase the proportion of patients achieving sustained virologic response 12 weeks after treatment completion (SVR12) compared with case management and referral (CMR) to specialist clinics?
- Does adding provider pay-for-performance (P4P) incentives to SHIM further improve progression along the HCV treatment cascade and SVR12 rates?
Researchers compared three models of care across 13 OAMT clinics in 12 Ukrainian cities:
- Case Management and Referral (CMR): structured referral to off-site specialist clinics for HCV treatment
- SHIM: simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
- SHIM + P4P: SHIM with provider incentives linked to completion of key cascade milestones All SHIM clinics were supported by Project ECHO telementoring to strengthen clinician capacity . The study used nationally procured direct-acting antivirals (DAAs) under routine program conditions and did not reimburse diagnostic costs.
Between February 2023 and December 2024, 616 eligible patients were enrolled .
Participants:
- Completed confirmatory HCV RNA testing
- Underwent simplified pretreatment clinical and laboratory assessment
- Received 12 weeks of pan-genotypic DAA treatment either onsite (SHIM arms) or at specialist clinics (CMR arm)
- Attended follow-up visits during treatment for adherence assessment and counseling
- Were prescribed HCV RNA testing 12 weeks after treatment completion to confirm cure (SVR12) The primary outcome was SVR12. Secondary outcomes included completion of pretreatment evaluation, treatment initiation, treatment completion, and completion of SVR assessment.
This study evaluates HCV care under real-world conditions during ongoing national treatment scale-up in Ukraine. The findings inform whether integrating simplified HCV treatment into OAMT clinics-and aligning provider incentives-can improve cure rates and accelerate progress toward HCV elimination in high-burden populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case Management and Referral | Active comparator | Other: Case Management and Referralstructured referral to off-site specialist clinics for HCV treatment |
| Simplified HCV Integrated Management | Experimental | Other: Simplified HCV Integrated Managementsimplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians |
| Simplified HCV Integrated Management + Pay-for-performance | Experimental | Other: Simplified HCV Integrated Management, Other: Pay-for-performancesimplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently receiving treatment at the selected OAT site (implying a diagnosis of opioid dependence according to ICD 10);
- aged 18 years or older;
- residing within the study catchment area; and
- having a positive HCV antibody test documented in the medical chart
Key exclusion criteria (5 listed)
- previous HCV treatment history;
- active tuberculosis (assessed using 4-item screening questionnaire and confirmed according to the current national protocol);
- pregnant or planning pregnancy in the next 6 months;
- planning to move to another city in the next 6 months;
- unwillingness to undergo confirmatory HCV RNA PCR test at their own expense and treat HCV
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 |
|---|---|---|
| Simplified HCV Integrated Managementsimplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians | Other | Simplified HCV Integrated Management, Simplified HCV Integrated Management + Pay-for-performance |
| Pay-for-performanceprovider incentives linked to completion of key cascade milestones | Other | Simplified HCV Integrated Management + Pay-for-performance |
| Case Management and Referralstructured referral to off-site specialist clinics for HCV treatment | Other | Case Management and Referral |
Primary outcome
Sustained virologic response
Time frame: Up to 24 weeks after treatment completion
Number of participants who have HCV RNA below the limit of quantitation (≤50 IU/mL) based on clinical records
5 secondary outcomes
Completion of all pretreatment diagnostic assessments
Time frame: Through study completion, an average of 2 weeks after baseline
Treatment initiation
Time frame: Through study completion, an average of 4 weeks after baseline
Treatment completion
Time frame: Through study completion, an average of 14 weeks after baseline
SVR assessment completion
Time frame: Up to 24 weeks after treatment completion
HCV reinfection
Time frame: 12 months after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified HCV Integrated Management, Pay-for-performance and Case Management and Referral in people with HCV and Opioid Use Disorder, run by Ukrainian Institute on Public Health Policy at 1 site in Ukraine.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sustained virologic response (time frame: Up to 24 weeks after treatment completion). 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 16 Sep 2026.