Hepatitis CNCT01857245
Intensive Models of HCV Care for Injection Drug Users
A study testing Intensive Models (mDOT and CGT) of HCV Care in people with Hepatitis C and Medication Adherence, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Medication Adherence
- What is being tested?
- Intensive Models (mDOT and CGT) of HCV Care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 30 Apr 2017
- 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
- HCV-infected, Genotype-1
- Treatment naïve or treatment experienced patients
- Willing to receive HCV treatment on-site
- Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
- Receiving methadone or buprenorphine in clinic at least one time per week
- Age 18 or older
Show all 32Show fewer
- Able to provide informed consent
- Psychiatrically stable
- English or Spanish speaking
- Currently enrolled in a methadone or buprenorphine treatment program in the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)
- HCV-infected, Genotype-1, , 2, 3, or 4
- Willing to receive HCV treatment on-site at an opiate agonist treatment program.
- Initiating treatment with sofosbuvir and ribavirin +/- pegylated interferon alfa-2a
- Age 18 or older
- Able to provide informed consent
- English or Spanish speaking
- Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)
- HCV-infected, Genotype-1 or 4
- Willing to receive HCV treatment on-site at an opiate agonist treatment program.
- Initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir.
- Age 18 or older
- Able to provide informed consent
- English or Spanish speaking
- Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)
- HCV-infected, Genotype-1
- Treatment naïve or treatment experienced patients
- Willing to receive HCV treatment on-site
- Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
- Age 18 or older
- Able to provide informed consent
- Psychiatrically stable
- English or Spanish speaking
Who cannot join
- Known hypersensitivity (allergy) to interferon, ribavirin or DAA
- Psychiatrically unstable
- Pregnant or breast-feeding
- PREVAIL 2:
- Known hypersensitivity (allergy) to interferon, ribavirin or sofosbuvir
- Pregnant or breast-feeding
Show all 13Show fewer
- PREVAIL 3:
- Known hypersensitivity (allergy) to sofosbuvir, simprevir or ledipasvir.
- Pregnant or breast-feeding
- PREVAIL 4
- Known hypersensitivity (allergy) to interferon, ribavirin or DAA
- Psychiatrically unstable
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29605
About this study
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care.
PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.
Read more
PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.
PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.
Read the detailed description
PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.
PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.
PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.
- Conditions
- Hepatitis C, Medication Adherence
- Being tested
- Intensive Models (mDOT and CGT) of HCV Care
- Keywords
- addiction, Adherence (attribute), Adverse effects, Agonist, Antiviral Agents, arm, base, care delivery, Caring, Chronic Hepatitis C, Clinic, Clinical Trials, Complex, Computer Simulation, cost, cost effective, cost effectiveness, Data, Development, Directly Observed Therapy
- Medical subject headings
- Hepatitis C, Medication Adherence, Behavior, Addictive, Hepatitis C, Chronic, Directly Observed Therapy, Disease, Infections, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Models (mDOT and CGT) of HCV CareOther
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
| Study group | Role | What they receive |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Experimental | In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window. Receives: Other: Intensive Models (mDOT and CGT) of HCV Care |
| Concurrent Group Treatment (CGT) | Experimental | In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections. Receives: Other: Intensive Models (mDOT and CGT) of HCV Care |
| Treatment as Usual | Active comparator | In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. Receives: Other: Intensive Models (mDOT and CGT) of HCV Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronically Monitored Medication Adherence
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
Measured: 1-12 weeks
Secondary outcomes (2)
Sustained Virologic Response
Undetectable HCV RNA at posttreatment week 12.
Measured: 12 weeks after treatment completion
HCV Treatment Completion
Completion of ≥80% of the planned treatment course. For example, ≥10 wk of a 12-wk course, or ≥20 wk of a 24-wk course.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study start1 Oct 2013
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
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 (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University, Albert Einstein College of Medicine
- Responsible party
- Sponsor
- Investigators
- Garland Gudger, MD, MPH, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857245
- Sponsor's protocol ID
- 1R01DA034086-01, 2011-555
- Other IDs
- 1R01DA034086-01
- Status last verified
- Jun 2018
- First submitted
- 16 May 2013
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heo M, Pericot-Valverde I, Rennert L, Akiyama MJ, Norton BL, Gormley M, Agyemang L, Arnsten JH, Litwin AH. Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs. Clin Infect Dis. 2021 Dec 6;73(11):2093-2100. doi: 10.1093/cid/ciab334.
PubMed 33876230Pericot-Valverde I, Heo M, Akiyama MJ, Norton BL, Agyemang L, Niu J, Litwin AH. Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial. BMC Infect Dis. 2020 Dec 4;20(1):928. doi: 10.1186/s12879-020-05667-3.
PubMed 33276738Akiyama MJ, Norton BL, Arnsten JH, Agyemang L, Heo M, Litwin AH. Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial. Ann Intern Med. 2019 May 7;170(9):594-603. doi: 10.7326/M18-1715. Epub 2019 Apr 9.
PubMed 30959528Akiyama MJ, Agyemang L, Arnsten JH, Heo M, Norton BL, Schackman BR, Linas BP, Litwin AH. Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy. BMC Infect Dis. 2018 Feb 9;18(1):74. doi: 10.1186/s12879-018-2964-5.
PubMed 29426304
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Models of HCV Care for Injection Drug Users
- ClinicalTrials.gov ID
- NCT01857245
- Acronym / sponsor ID
- 1R01DA034086-01, 2011-555
- Conditions
- Hepatitis C, Medication Adherence
- Keywords
- addiction, Adherence (attribute), Adverse effects, Agonist, Antiviral Agents, arm, base, care delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University, Albert Einstein College of Medicine
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care.
PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.
PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.
PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.
Detailed description
PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.
PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.
PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Experimental | Other: Intensive Models (mDOT and CGT) of HCV CareIn our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window. |
| Concurrent Group Treatment (CGT) | Experimental | Other: Intensive Models (mDOT and CGT) of HCV CareIn our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections. |
| Treatment as Usual | Active comparator | Other: Intensive Models (mDOT and CGT) of HCV CareIn the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- HCV-infected, Genotype-1
- Treatment naïve or treatment experienced patients
- Willing to receive HCV treatment on-site
- Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
- Receiving methadone or buprenorphine in clinic at least one time per week
Key exclusion criteria (13 listed)
- Known hypersensitivity (allergy) to interferon, ribavirin or DAA
- Psychiatrically unstable
- Pregnant or breast-feeding
- Known hypersensitivity (allergy) to interferon, ribavirin or sofosbuvir
- Pregnant or breast-feeding
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 |
|---|---|---|
| Intensive Models (mDOT and CGT) of HCV CareModified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models. | Other | Concurrent Group Treatment (CGT), Modified Directly Observed Therapy (mDOT), Treatment as Usual |
Primary outcome
Electronically Monitored Medication Adherence
Time frame: 1-12 weeks
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
2 secondary outcomes
Sustained Virologic Response
Time frame: 12 weeks after treatment completion
HCV Treatment Completion
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33876230Heo M, Pericot-Valverde I, Rennert L, Akiyama MJ, Norton BL, Gormley M, Agyemang L, Arnsten JH, Litwin AH. Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs. Clin Infect Dis. 2021 Dec 6;73(11):2093-2100. doi: 10.1093/cid/ciab334.
- Derived from this study: PubMed 33276738Pericot-Valverde I, Heo M, Akiyama MJ, Norton BL, Agyemang L, Niu J, Litwin AH. Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial. BMC Infect Dis. 2020 Dec 4;20(1):928. doi: 10.1186/s12879-020-05667-3.
- Derived from this study: PubMed 30959528Akiyama MJ, Norton BL, Arnsten JH, Agyemang L, Heo M, Litwin AH. Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial. Ann Intern Med. 2019 May 7;170(9):594-603. doi: 10.7326/M18-1715. Epub 2019 Apr 9.
- Derived from this study: PubMed 29426304Akiyama MJ, Agyemang L, Arnsten JH, Heo M, Norton BL, Schackman BR, Linas BP, Litwin AH. Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy. BMC Infect Dis. 2018 Feb 9;18(1):74. doi: 10.1186/s12879-018-2964-5.
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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.
Garland Gudger, MD, MPH principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Models (mDOT and CGT) of HCV Care in people with Hepatitis C and Medication Adherence, run by Prisma Health-Upstate at 1 site in United States.
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 32 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 3 Feb 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 United States. 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 3 Feb 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?
Electronically Monitored Medication Adherence (time frame: 1-12 weeks). 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 NCT01857245, which also lists 4 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 3 Feb 2025.