HCVNCT06483451
Facilitated Telemedicine in the Bassett Health System
An observational study of HCV, run by State University of New York at Buffalo.
Trial summary
Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Individuals enrolled in the opioid treatment programs of Catholic Health System
Who may be able to join
- evidence of active HCV infection
Who cannot join
- no evidence of active HCV infection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hepatitis C Virus Management Through Facilitated Telemedicine Integrated Into Opioid Treatment Programs: Bassett Health System Experience
Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.
Read the detailed description
Hepatitis C virus (HCV) is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. In 2013, direct-acting antivirals were introduced for HCV treatment: all oral medications with minimal side effects and excellent efficacy when taken for 2-3 months. However, only 34% of eligible individuals received direct-acting antivirals between 2013 and 2022. Moreover, HCV treatment with direct-acting antivirals was substantially lower among people with opioid use disorder. Access to highly effective HCV treatment by the populations with the greatest need remains inadequate.
To address this issue, we propose that facilitated telemedicine could be a bridge to integrate HCV treatment into opioid treatment programs. In our model, telemedicine encounters are facilitated by a case manager who is also a patient advocate and an educator. We recently completed a randomized clinical trial that compared facilitated telemedicine integrated into opioid treatment programs for HCV treatment compared to offsite referral. The HCV cure rate was 90.3% in facilitated telemedicine compared to 39.4% in offsite referral.
In the proposed project, we seek to establish facilitated telemedicine as a standard of care treatment approach within the Bassett Health System.
- Conditions
- HCV
- Keywords
- telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with active HCV infection | Individuals with active HCV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Treatment Initiation
The time point that HCV treatment is initiated
Measured: 1 year
HCV Sustained Virologic Response
The time point that HCV cure (sustained virologic response) is achieved
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCVStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Talal, State University of New York at Buffalo
- Investigators
- Andrew H Talal, MD, MPH, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483451
- Sponsor's protocol ID
- STUDY00008372
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be de-identified. Available upon reasonable request after publication of study results.
Publications
Talal 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 38568601
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus Management Through Facilitated Telemedicine Integrated Into Opioid Treatment Programs: Bassett Health System Experience
- ClinicalTrials.gov ID
- NCT06483451
- Acronym / sponsor ID
- STUDY00008372
- Conditions
- HCV
- Keywords
- telemedicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jul 2024 (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.
Hepatitis C virus is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. We aim to establish facilitated telemedicine as a standard of care treatment approach at 3 opioid treatment programs operated by the Catholic Health System. This study is a chart review data analysis to evaluate outcomes of facilitated telemedicine integrated into opioid treatment programs and to evaluate the number of individuals who initiate and complete treatment for hepatitis C virus infection.
Detailed description
Hepatitis C virus (HCV) is a leading cause of morbidity and mortality globally with the highest prevalence and incidence among people with opioid use disorder. In 2013, direct-acting antivirals were introduced for HCV treatment: all oral medications with minimal side effects and excellent efficacy when taken for 2-3 months. However, only 34% of eligible individuals received direct-acting antivirals between 2013 and 2022. Moreover, HCV treatment with direct-acting antivirals was substantially lower among people with opioid use disorder. Access to highly effective HCV treatment by the populations with the greatest need remains inadequate.
To address this issue, we propose that facilitated telemedicine could be a bridge to integrate HCV treatment into opioid treatment programs. In our model, telemedicine encounters are facilitated by a case manager who is also a patient advocate and an educator. We recently completed a randomized clinical trial that compared facilitated telemedicine integrated into opioid treatment programs for HCV treatment compared to offsite referral. The HCV cure rate was 90.3% in facilitated telemedicine compared to 39.4% in offsite referral.
In the proposed project, we seek to establish facilitated telemedicine as a standard of care treatment approach within the Bassett Health System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with active HCV infection | – | –Individuals with active HCV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals enrolled in the opioid treatment programs of Catholic Health System
Key inclusion criteria (1 listed)
- evidence of active HCV infection
Key exclusion criteria (1 listed)
- no evidence of active HCV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCV Treatment Initiation
Time frame: 1 year
The time point that HCV treatment is initiated
HCV Sustained Virologic Response
Time frame: 1 year
The time point that HCV cure (sustained virologic response) is achieved
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: 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.
- Individual participant dataSharing planned: Undecided. Data will be de-identified. Available upon reasonable request after publication of study results.
Related trials for HCV
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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.
Andrew H Talal, MD, MPH principal investigator
University at Buffalo
Questions about this trial
What is this clinical trial studying?
An observational study of HCV, run by State University of New York at Buffalo.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew H Talal, MD, MPH (7168293101, ahtalal@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Treatment Initiation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06483451, which also lists 1 linked publication.
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 Oct 2026.