Hepatitis CSTOP-CNCT04652804
Supporting Treatment Outcomes Among PWID
A study testing Low intensity HCV treatment adherence support, Medium intensity HCV treatment adherence support and High intensity HCV treatment adherence support in people with Hepatitis C and HIV Coinfection, run by Johns Hopkins University at 1 site in India.
Trial summary
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV Coinfection
- What is being tested?
- Low intensity HCV treatment adherence support, Medium intensity HCV treatment adherence support and High intensity HCV treatment adherence support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Registered for care at an Integrated Care Center (ICC) in one of the 7 field sites.
- Active HCV infection confirmed by a detectable HCV RNA by polymerase chain reaction (PCR) (HCV RNA ≥ 30 copies/ml) within 90 days prior to study entry.
- Liver disease stage defined as non-cirrhotic or compensated cirrhotic (metric/diagnostic criteria used for fibrosis staging) within 90 days prior to study entry.
- Albumin >3.0 g/L. ii. Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men. iii. Platelet count >50,000/mm3. iv. Calculated creatinine clearance (CrCl) using Cockcroft-Gault method >30 mL/min. v. Aspartate aminotransferase (AST/SGOT) <10 times the upper limit of the normal range (ULN). vi. Alanine aminotransferase (ALT/SGPT) <10 times the ULN. vii. Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV) and <3 times the ULN for participants on ATV. viii. International normalized ratio (INR) <1.5 times the ULN.
- Life expectancy greater than 1 year (as determined by study clinician)
- Willing to initiate HCV treatment
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- Agree to be randomized to an adherence support strategy
- Ability and willingness to provide written informed consent
- Female participants of reproductive potential must not be pregnant
- All female participants of reproductive potential must agree not to participate in a conception process
- All female participants of reproductive potential must agree to use at least one reliable form of contraceptive while receiving protocol-specified medication, and for 6 weeks after stopping the medication.
Who cannot join
- Psychologically unfit to provide written informed consent.
- Planning to migrate within the next six months.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
- In HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 30 days prior to study entry.
- Use of prohibited medications within the past 14 days prior to study entry.
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- Evidence of decompensated liver disease on clinical exam.
- Evidence of active tuberculosis.
- Evidence of chronic hepatitis B infection (HBsAg positive).
- Currently on HCV treatment.
- Prior history of DAA-based HCV treatment
- Confirmed active SARS CoV-2 infection or suspected active SARS CoV-2 infection at enrollment.
- Currently nursing (breastfeeding).
Trial locations and contacts
1 site in 1 country.
India1 site
YR Gaitonde Centre for AIDS Research and Education
Chennai, Tamil Nadu, 600010
About this study
Official title: A Precision Randomized Trial to Evaluate the Impact of Tailored Hepatitis C Virus (HCV) Treatment Adherence Support on HCV Treatment Outcomes in HIV/HCV Co-infected and HCV Mono-infected People Who Inject Drugs (PWID) in India.
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.
Read the detailed description
The primary objective is to evaluate whether the intensity of treatment adherence support affects sustained virologic response rates in HCV mono- and HIV/HCV co-infected participants receiving HCV direct-acting antivirals (DAA) in PWID-focused centers. Secondary objectives are: 1. To evaluate whether the intensity of treatment adherence support affects HCV treatment completion rates. 2. To evaluate whether the intensity of treatment adherence support affects HCV treatment adherence. 3. To estimate the incidence and correlates of HCV reinfection among HCV mono- and HIV/HCV coinfected PWID who achieve HCV cure. 4. To evaluate the impact of HCV cure on HIV viral suppression among HIV/HCV coinfected PWID.
Investigators will evaluate this via a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). An estimated 3,000 persons will be enrolled and randomized at 7 community-based integrated care centers (ICCs) across India across a duration of 18 - 24 months. Data from these 7 ICCs on early HIV treatment refills/viral suppression (3-6 months after antiretroviral therapy (ART) initiation) will be used to develop and validate an algorithm to predict propensity for HCV treatment failure. Prior to treatment initiation, each participant will undergo a questionnaire to capture information on barriers/ facilitators to treatment adherence identified in the prediction model in order to determine the propensity for HCV treatment failure (minimal or elevated risk). Individuals will be preferentially randomized to the support level that matches their failure risk. Those at elevated risk for treatment failure will be randomized at an allocation ratio of 3:2:1 for Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Conversely, those at minimal risk will be randomized at a ratio of 1:2:3 to Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Participants and study staff will be blinded to the risk classification (minimal, elevated) but, because of the nature of the interventions, blinding to intervention assignment is not possible.
Persons will be treated for HCV according to the standard of care in India. Minimal laboratory monitoring will be used except when clinically indicated. Participants with decompensated cirrhosis will be excluded from treatment.
All HIV/HCV co-infected participants and those HCV monoinfected participants who achieve SVR will be followed post-treatment. These individuals will be followed every six months after the SVR assessment to assess HCV reinfection and HIV viral suppression (among HIV/HCV coinfected participants) for up to 30 months after SVR.
- Conditions
- Hepatitis C, HIV Coinfection
- Being tested
- Low intensity HCV treatment adherence support, Medium intensity HCV treatment adherence support, High intensity HCV treatment adherence support
- Keywords
- Patient Navigation, Treatment Adherence, People who inject drugs (PWID), Directly Observed Therapy (DOT), India
- Medical subject headings
- Hepatitis C, HIV Infections, Treatment Adherence and Compliance, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity HCV treatment adherence supportBehavioural
A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements
Medium intensity HCV treatment adherence supportBehavioural
The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks.
High intensity HCV treatment adherence supportBehavioural
The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Low Intensity Intervention | Active comparator | 4 weeks dispensation + standard adherence counseling Receives: Behavioral: Low intensity HCV treatment adherence support |
| Arm 2: Medium Intensity Intervention | Active comparator | 4 weeks dispensation + support from patient navigator Receives: Behavioral: Medium intensity HCV treatment adherence support |
| Arm 3: High Intensity Intervention | Active comparator | Directly Observed Therapy with flexible dispensing and support from patient navigator Receives: Behavioral: High intensity HCV treatment adherence support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated)
The percentage of participants who achieved SVR defined as HCV RNA < lower limit of quantification (LLOQ). HCV RNA < lower limit of quantification (LLOQ, 30 IU/ml) was measured 12 weeks (range 10 - 60 weeks) after treatment completion.
Measured: Between 10 and 60 weeks after scheduled end of treatment.
Secondary outcomes (7)
HCV Treatment Completion
The percentage of participants who completed the prescribed course of treatment (12 or 24 weeks). Participants with compensated cirrhosis and genotype 3 infection would have received 24 weeks of treatment. All other participants would have received treatment for 12 weeks. All participants in this study received 12 weeks of treatment.
Measured: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence >90% (Self-report)
The percentage of participants who self-report taking >90% of doses during treatment.
Measured: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence >90% (Medication Records)
The percentage of participants in possession of >90% of doses during treatment based on medication refills and pill counts.
Measured: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence Level (Self-report)
The percentage of doses taken during treatment as self-reported by the participant.
Measured: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence Level (Medication Records)
The percentage of doses participants had in their possession during treatment based on medication refills and pill counts.
Measured: Measured at the end of prescribed course of treatment (12 or 24 weeks)
HCV Reinfection
The percentage of participants who test positive for HCV Core Antigen after achieving SVR.
Measured: Measured at 6 month intervals after confirmation of SVR for up to 36 months.
HIV Viral Suppression Among HIV/HCV Coinfected Participants
The percentage of HIV/HCV co-infected participants with HIV RNA less than LLOQ after the SVR assessment. HCV RNA abstracted from chart reviews.
Measured: After assessment of SVR for up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start21 Jan 2021
- Primary completion30 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). Minimal risk individuals have a higher likelihood of being allocated to lower intensity intervention and elevated risk individuals have higher likelihood of being allocated to higher intensity intervention.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Sunil S Solomon, PhD MBBS MPH, Principal investigator, Johns Hopkins University School of Medicine and Y.R. Gaitonde Centre for AIDS Research and EducationShruti H Mehta, PhD MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652804
- Sponsor's protocol ID
- IRB00232125
- Other IDs
- 5R01AI145555-02
- Acronym
- STOP-C
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2020
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solomon SS, Srikrishnan AK, McFall AM, Baishya J, Gunaratne MP, Kedar A, Amrose P, Balakrishnan R, Boobalan J, Evans J, Lau BM, Ehrhardt S, Sulkowski MS, Thomas DL, Lucas GM, Suresh Kumar M, Mehta SH. A precision randomized trial of hepatitis C treatment support among people who inject drugs in India: The STOP-C Trial. J Hepatol. 2026 Jun 30:S0168-8278(26)02683-8. doi: 10.1016/j.jhep.2026.06.034. Online ahead of print.
PubMed 42379314Mehta SH, Lau BM, Ehrhardt S, McFall A, Gunaratne MP, Baishya J, Kedar A, Srikrishnan AK, Evans J, Loeb T, Pradeep A, Kumar MS, Thomas DL, Lucas GM, Solomon SS. A precision randomized trial to evaluate the impact of tailored hepatitis C treatment adherence support on HCV treatment outcomes among people who inject drugs in India: design and baseline characteristics of the STOP-C trial. Am J Epidemiol. 2025 Oct 7;194(10):2986-2998. doi: 10.1093/aje/kwae430.
PubMed 39572371
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Randomized Trial to Evaluate the Impact of Tailored Hepatitis C Virus (HCV) Treatment Adherence Support on HCV Treatment Outcomes in HIV/HCV Co-infected and HCV Mono-infected People Who Inject Drugs (PWID) in India.
- ClinicalTrials.gov ID
- NCT04652804
- Acronym / sponsor ID
- STOP-C / IRB00232125
- Conditions
- Hepatitis C, HIV Coinfection
- Keywords
- Patient Navigation, Treatment Adherence, People who inject drugs (PWID), Directly Observed Therapy (DOT), India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 8 Apr 2025
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 study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.
Detailed description
The primary objective is to evaluate whether the intensity of treatment adherence support affects sustained virologic response rates in HCV mono- and HIV/HCV co-infected participants receiving HCV direct-acting antivirals (DAA) in PWID-focused centers. Secondary objectives are: 1. To evaluate whether the intensity of treatment adherence support affects HCV treatment completion rates. 2. To evaluate whether the intensity of treatment adherence support affects HCV treatment adherence. 3. To estimate the incidence and correlates of HCV reinfection among HCV mono- and HIV/HCV coinfected PWID who achieve HCV cure. 4. To evaluate the impact of HCV cure on HIV viral suppression among HIV/HCV coinfected PWID.
Investigators will evaluate this via a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). An estimated 3,000 persons will be enrolled and randomized at 7 community-based integrated care centers (ICCs) across India across a duration of 18 - 24 months. Data from these 7 ICCs on early HIV treatment refills/viral suppression (3-6 months after antiretroviral therapy (ART) initiation) will be used to develop and validate an algorithm to predict propensity for HCV treatment failure. Prior to treatment initiation, each participant will undergo a questionnaire to capture information on barriers/ facilitators to treatment adherence identified in the prediction model in order to determine the propensity for HCV treatment failure (minimal or elevated risk). Individuals will be preferentially randomized to the support level that matches their failure risk. Those at elevated risk for treatment failure will be randomized at an allocation ratio of 3:2:1 for Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Conversely, those at minimal risk will be randomized at a ratio of 1:2:3 to Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Participants and study staff will be blinded to the risk classification (minimal, elevated) but, because of the nature of the interventions, blinding to intervention assignment is not possible.
Persons will be treated for HCV according to the standard of care in India. Minimal laboratory monitoring will be used except when clinically indicated. Participants with decompensated cirrhosis will be excluded from treatment.
All HIV/HCV co-infected participants and those HCV monoinfected participants who achieve SVR will be followed post-treatment. These individuals will be followed every six months after the SVR assessment to assess HCV reinfection and HIV viral suppression (among HIV/HCV coinfected participants) for up to 30 months after SVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). Minimal risk individuals have a higher likelihood of being allocated to lower intensity intervention and elevated risk individuals have higher likelihood of being allocated to higher intensity intervention.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Low Intensity Intervention | Active comparator | Behavioral: Low intensity HCV treatment adherence support4 weeks dispensation + standard adherence counseling |
| Arm 2: Medium Intensity Intervention | Active comparator | Behavioral: Medium intensity HCV treatment adherence support4 weeks dispensation + support from patient navigator |
| Arm 3: High Intensity Intervention | Active comparator | Behavioral: High intensity HCV treatment adherence supportDirectly Observed Therapy with flexible dispensing and support from patient navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Registered for care at an Integrated Care Center (ICC) in one of the 7 field sites.
- Active HCV infection confirmed by a detectable HCV RNA by polymerase chain reaction (PCR) (HCV RNA ≥ 30 copies/ml) within 90 days prior to study entry.
- Liver disease stage defined as non-cirrhotic or compensated cirrhotic (metric/diagnostic criteria used for fibrosis staging) within 90 days prior to study entry.
- Life expectancy greater than 1 year (as determined by study clinician)
- Willing to initiate HCV treatment
Key exclusion criteria (13 listed)
- Psychologically unfit to provide written informed consent.
- Planning to migrate within the next six months.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
- In HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 30 days prior to study entry.
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 |
|---|---|---|
| Low intensity HCV treatment adherence supportA 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements | Behavioural | Arm 1: Low Intensity Intervention |
| Medium intensity HCV treatment adherence supportThe medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. | Behavioural | Arm 2: Medium Intensity Intervention |
| High intensity HCV treatment adherence supportThe high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. | Behavioural | Arm 3: High Intensity Intervention |
Primary outcome
Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated)
Time frame: Between 10 and 60 weeks after scheduled end of treatment.
The percentage of participants who achieved SVR defined as HCV RNA < lower limit of quantification (LLOQ). HCV RNA < lower limit of quantification (LLOQ, 30 IU/ml) was measured 12 weeks (range 10 - 60 weeks) after treatment completion.
7 secondary outcomes
HCV Treatment Completion
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence >90% (Self-report)
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence >90% (Medication Records)
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence Level (Self-report)
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
Adherence Level (Medication Records)
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
HCV Reinfection
Time frame: Measured at 6 month intervals after confirmation of SVR for up to 36 months.
HIV Viral Suppression Among HIV/HCV Coinfected Participants
Time frame: After assessment of SVR for up to 36 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42379314Solomon SS, Srikrishnan AK, McFall AM, Baishya J, Gunaratne MP, Kedar A, Amrose P, Balakrishnan R, Boobalan J, Evans J, Lau BM, Ehrhardt S, Sulkowski MS, Thomas DL, Lucas GM, Suresh Kumar M, Mehta SH. A precision randomized trial of hepatitis C treatment support among people who inject drugs in India: The STOP-C Trial. J Hepatol. 2026 Jun 30:S0168-8278(26)02683-8. doi: 10.1016/j.jhep.2026.06.034. Online ahead of print.
- Derived from this study: PubMed 39572371Mehta SH, Lau BM, Ehrhardt S, McFall A, Gunaratne MP, Baishya J, Kedar A, Srikrishnan AK, Evans J, Loeb T, Pradeep A, Kumar MS, Thomas DL, Lucas GM, Solomon SS. A precision randomized trial to evaluate the impact of tailored hepatitis C treatment adherence support on HCV treatment outcomes among people who inject drugs in India: design and baseline characteristics of the STOP-C trial. Am J Epidemiol. 2025 Oct 7;194(10):2986-2998. doi: 10.1093/aje/kwae430.
- 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.
Sunil S Solomon, PhD MBBS MPH principal investigator
Johns Hopkins University School of Medicine and Y.R. Gaitonde Centre for AIDS Research and Education
Shruti H Mehta, PhD MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity HCV treatment adherence support, Medium intensity HCV treatment adherence support and High intensity HCV treatment adherence support in people with Hepatitis C and HIV Coinfection, run by Johns Hopkins University at 1 site in India.
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 11 inclusion and 13 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 8 Apr 2025. 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 India. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) (time frame: Between 10 and 60 weeks after scheduled end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652804, which also lists 2 linked publications.
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 8 Apr 2025.