NCT04798521

TeleHepC Treatment Trial

Completed NA Results posted Last updated 8 October 2024

What this trial tests

NA trial testing Tele-HCV in Hepatitis C in 203 participants. Completed in 10 January 2024.

Timeline

30 June 2020

Primary endpoint
25 August 2023

10 January 2024

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	203
Start date	30 June 2020
Primary completion	25 August 2023
Estimated completion	10 January 2024
Sites	3 locations across United States

Drugs / interventions tested

• Tele-HCV
• Community Linkage to Care

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →

Sponsor

Oregon Health and Science University

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.

Viral Response Primary · 12 weeks post treatment

Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.

Group	Value	95% CI
Tele-HCV Treatment	63
Community Linkage to Care	16

Treatment Initiation Secondary · 4 weeks

Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.

Group	Value	95% CI
Tele-HCV Treatment	85
Community Linkage to Care	13

Treatment Completion Secondary · 36 weeks post treatment

HCV treatment completion, filled final prescription. 90% of HCV pills taken

Group	Value	95% CI
Tele-HCV Treatment	46
Community Linkage to Care	9

Engagement in Harm Reduction Resources Secondary · Baseline, 12 weeks, and 36 Weeks

Participants complete surveys to assess whether or not they are regularly engaging in substance use and harm reduction resources in the community. Surveys conducted a Baseline, 12 weeks, and 36 weeks.

Baseline

Group	Value	95% CI
Tele-HCV Treatment	100
Community Linkage to Care	103

12 Weeks

Group	Value	95% CI
Tele-HCV Treatment	88
Community Linkage to Care	83

36 Weeks

Group	Value	95% CI
Tele-HCV Treatment	61
Community Linkage to Care	68

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over the 1 year a participant was enrolled in the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tele-HCV Treatment

Serious: 1/100 (1%)

Deaths: 3/100

Community Linkage to Care

Serious: 4/103 (4%)

Deaths: 2/103

Serious adverse events (4 terms)

Reaction	System	Tele-HCV Treatment	Community Linkage to Care
Overdose, non-fatal	Social circumstances	—	—
Cardiac event	Cardiac disorders	—	—
Gastrointestinal event	Gastrointestinal disorders	—	—
AIDS-related event	Immune system disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Tele-HCV Treatment	Community Linkage to Care
Unintentional injury	Injury, poisoning and procedural complications	—	—
Psychological event	Psychiatric disorders	—	—
Gastrointestinal event	Gastrointestinal disorders	—	—

Most-reported serious reactions: Overdose, non-fatal, Cardiac event, Gastrointestinal event, AIDS-related event.

Data from ClinicalTrials.gov NCT04798521 adverse events section.

Sponsor's own description

The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).

Publications & conference data

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

1. Peer-Assisted Telemedicine for Hepatitis C in People Who Use Drugs: A Randomized Controlled Trial.
   Seaman A, Cook R, Leichtling G, Herink MC, et al · · 2025 · cited 15× · PMID 39602441 · DOI 10.1093/cid/ciae520
2. A randomized controlled trial for a peer-facilitated telemedicine hepatitis c treatment intervention for people who use drugs in rural communities: study protocol for the "peer tele-HCV" study.
   Herink MC, Seaman A, Leichtling G, Larsen JE, et al · · 2023 · cited 12× · PMID 37245041 · DOI 10.1186/s13722-023-00384-z
3. Harm Reduction in Peer-Assisted Telemedicine for Hepatitis C: Secondary Outcomes of a Randomized Controlled Trial.
   Spencer H, Gregoire D, Leichtling G, Herink M, et al · · 2024 · cited 1× · PMID 39339931 · DOI 10.3390/v16091455
4. Peer-assisted telemedicine for hepatitis C intervention in people experiencing housing instability.
   Herink MC, Spencer HC, Cook RR, Gregoire D, et al · · 2026 · PMID 41645194 · DOI 10.1186/s12954-026-01408-y