NCT02933970

Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

Completed NA Results posted Last updated 20 December 2024

What this trial tests

NA trial testing Telemedicine in Hepatitis C in 602 participants. Completed in 1 November 2022.

Timeline

28 February 2017

Primary endpoint
1 October 2020

1 November 2022

Quick facts

Lead sponsor	Andrew Talal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	602
Start date	28 February 2017
Primary completion	1 October 2020
Estimated completion	1 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Telemedicine

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →

Sponsor

Andrew Talal

Who can join

18 and older, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication Primary · 12 weeks post treatment cessation

Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)

Group	Value	95% CI
Control	106
Intervention	246

Comparison of Treatment Initiation Percentages Secondary · Up to 160 weeks

Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose.

Group	Value	95% CI
Control	126
Intervention	268

Comparison of Treatment Completion Rates Secondary · Up to 210 weeks

Comparison of treatment completion percentages between the two arms.

Group	Value	95% CI
Control	116
Intervention	261

Comparison of Patient Satisfaction Secondary · Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).

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

Initial Time point

Group	Value	95% CI
Control	91.5
Intervention	98.3

HCV cure time point

Group	Value	95% CI
Control	91.5
Intervention	98.7

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.
   Talal AH, Markatou M, Liu A, Perumalswami PV, et al · · 2024 · cited 49× · PMID 38568601 · DOI 10.1001/jama.2024.2452
2. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study.
   Talal AH, Sofikitou EM, Wang K, Dickerson S, et al · · 2023 · cited 21× · PMID 35925809 · DOI 10.1089/tmj.2022.0189
3. Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study.
   Dickerson SS, George SJ, Ventuneac A, Dharia A, et al · · 2024 · cited 9× · PMID 38865703 · DOI 10.2196/53049
4. Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study.
   Ventuneac A, Dickerson SS, Dharia A, George SJ, et al · · 2023 · cited 9× · PMID 37252770 · DOI 10.1089/tmj.2022.0534
5. Long-Term Benefits Following Hepatitis C Cure Through Facilitated Telemedicine; Experiences of People With Opioid use Disorder Five Years After Achieving a Sustained Virological Response.
   Papalamprakopoulou Z, Dang TH, Gonzalez CJ, Tedesco CJ, et al · · 2025 · cited 1× · PMID 40990152 · DOI 10.1111/hex.70404
6. Improvements in substance use and social determinants of health associated with hepatitis C treatment initiation and sustained virologic response in opioid treatment programs.
   Talal AH, Mukhopadhyay R, Veronesi V, Dharia A, et al · · 2026 · PMID 41852549 · DOI 10.1016/j.abrep.2026.100683
7. Opioid treatment program-integrated facilitated telemedicine for hepatitis C treatment: a hybrid effectiveness-implementation analysis.
   Talal AH, Markatou M, Zeremski M, Liu A, et al · · 2025 · PMID 41094463 · DOI 10.1186/s12906-025-05138-9
8. Implementation and Clinical Outcomes of Facilitated Telemedicine in Opioid Treatment Programs: A Hybrid Effectiveness-Implementation Analysis
   Talal AH, Markatou M, Zeremski M, Liu A, et al · · 2024 · DOI 10.21203/rs.3.rs-4486952/v1