Hepatitis CNCT02933970
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
A study testing Telemedicine in people with Hepatitis C, run by Andrew Talal at 1 site in United States.
Trial summary
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 1 Nov 2022
- 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 antibody detected
- Ability and willingness of subject or legal representative to provide written informed consent.
- 18 years of age
- A minimum of 12-month enrollment in the opiate agonist treatment program
- Likely to be adherent to the therapeutic regimen
- Covered by medical insurance
Who cannot join
- Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
- <18 years of age
- < 12 months enrolled in an opiate agonist treatment program.
- Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
- Lack of medical insurance coverage
- Ineligibility for HCV treatment
- Active treatment for HCV at the time of the study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
Read the detailed description
The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.
- Conditions
- Hepatitis C
- Being tested
- Telemedicine
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Two way video conferencing
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist |
| Intervention | Other | Telemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine) Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
Measured: 12 weeks post treatment cessation
Secondary outcomes (3)
Comparison of Treatment Initiation Percentages
Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose.
Measured: Up to 160 weeks
Comparison of Treatment Completion Rates
Comparison of treatment completion percentages between the two arms.
Measured: Up to 210 weeks
Comparison of Patient Satisfaction
We assessed patient satisfaction with healthcare delivery between the two arms through the Patient Satisfaction Questionnaire (PSQ) (1). The instrument is comprised of 18 questions from 7 subscales with responses on a 5-point Likert scale ranging from "1=Strongly Agree" to "5=Strongly Disagree". We administered the PSQ-18 at baseline and at the SVR time point. The higher the scored value, the higher the satisfaction. We calculated the score per participant, per time point, as the average of the scored values of all questions answered out of 18, and subsequently rounded the average score to the nearest integer (2).
- Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). Santa Monica, CA: RAND, 1994.
- Talal AH, Sofikitou EM, Wang K, Dickerson SS, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E-Health, 2023; 29: 395-407.
Measured: Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start28 Feb 2017
- Primary completion1 Oct 2020
- Study completion1 Nov 2022
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 (5)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Talal
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Andrew Talal, State University of New York at Buffalo
- Investigators
- Andrew H Talal, MD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933970
- Sponsor's protocol ID
- Telemedicine vs. Usual Care
- Status last verified
- Dec 2024
- First submitted
- 24 Sep 2016
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the completion of the study, the data will be filed with the Patient-Centered Outcomes Research Institute and will be publicly availability.
Publications
Talal AH, Markatou M, Zeremski M, Liu A, Dharia A, George SG, Taylor M, Davis K, Silber A, Brown LS, Tobin JN. Opioid treatment program-integrated facilitated telemedicine for hepatitis C treatment: a hybrid effectiveness-implementation analysis. BMC Complement Med Ther. 2025 Oct 15;25(1):377. doi: 10.1186/s12906-025-05138-9.
PubMed 41094463Dickerson SS, George SJ, Ventuneac A, Dharia A, Talal AH. Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study. J Med Internet Res. 2024 Jun 12;26:e53049. doi: 10.2196/53049.
PubMed 38865703Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA. 2024 Apr 23;331(16):1369-1378. doi: 10.1001/jama.2024.2452.
PubMed 38568601Ventuneac A, Dickerson SS, Dharia A, George SJ, Talal AH. Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study. Telemed J E Health. 2023 Dec;29(12):1862-1869. doi: 10.1089/tmj.2022.0534. Epub 2023 May 26.
PubMed 37252770Talal AH, Sofikitou EM, Wang K, Dickerson S, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E Health. 2023 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4.
PubMed 35925809
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
- ClinicalTrials.gov ID
- NCT02933970
- Acronym / sponsor ID
- Telemedicine vs. Usual Care
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Andrew TalalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
Detailed description
The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist |
| Intervention | Other | Other: TelemedicineTelemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCV antibody detected
- Ability and willingness of subject or legal representative to provide written informed consent.
- 18 years of age
- A minimum of 12-month enrollment in the opiate agonist treatment program
- Likely to be adherent to the therapeutic regimen
Key exclusion criteria (7 listed)
- Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
- <18 years of age
- < 12 months enrolled in an opiate agonist treatment program.
- Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
- Lack of medical insurance coverage
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 |
|---|---|---|
| TelemedicineAlso: Two way video conferencingPatients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member | Other | Intervention |
Primary outcome
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
Time frame: 12 weeks post treatment cessation
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
3 secondary outcomes
Comparison of Treatment Initiation Percentages
Time frame: Up to 160 weeks
Comparison of Treatment Completion Rates
Time frame: Up to 210 weeks
Comparison of Patient Satisfaction
Time frame: Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41094463Talal AH, Markatou M, Zeremski M, Liu A, Dharia A, George SG, Taylor M, Davis K, Silber A, Brown LS, Tobin JN. Opioid treatment program-integrated facilitated telemedicine for hepatitis C treatment: a hybrid effectiveness-implementation analysis. BMC Complement Med Ther. 2025 Oct 15;25(1):377. doi: 10.1186/s12906-025-05138-9.
- Derived from this study: PubMed 38865703Dickerson SS, George SJ, Ventuneac A, Dharia A, Talal AH. Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study. J Med Internet Res. 2024 Jun 12;26:e53049. doi: 10.2196/53049.
- Derived from this study: PubMed 38568601Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA. 2024 Apr 23;331(16):1369-1378. doi: 10.1001/jama.2024.2452.
- Derived from this study: PubMed 37252770Ventuneac A, Dickerson SS, Dharia A, George SJ, Talal AH. Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study. Telemed J E Health. 2023 Dec;29(12):1862-1869. doi: 10.1089/tmj.2022.0534. Epub 2023 May 26.
- Derived from this study: PubMed 35925809Talal AH, Sofikitou EM, Wang K, Dickerson S, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E Health. 2023 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. At the completion of the study, the data will be filed with the Patient-Centered Outcomes Research Institute and will be publicly availability.
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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.
Andrew H Talal, MD principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Hepatitis C, run by Andrew Talal 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 6 inclusion and 7 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 20 Dec 2024. 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 2 Dec 2024). 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?
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication (time frame: 12 weeks post treatment cessation). 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 NCT02933970, which also lists 5 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 20 Dec 2024.