Mobile Tele-HCV Care for Hepatitis C

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mobile Study Van, Keene, NH
Hepatitis C+3 More
Mobile Tele-HCV Care - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will integrate mobile hepatitis C virus (HCV) testing and treatment with expanded syringe access in order to improve uptake of HCV testing and treatment, and reduce syringe sharing behavior in rural northern New England. The intervention aims to reach rural opioid injectors with HCV and to fill service gaps identified around access to syringe services and HCV testing and treatment, while limiting the burden on local partners. If effective, this mobile model of HCV telehealth integrated with syringe services will provide a promising approach for local public health authorities seeking to curb opioid injection, syringe sharing and HCV rates in rural America, and reduce the risk environment for HIV outbreaks in those communities.

Eligible Conditions

  • Hepatitis C
  • Opioid Use Disorder (OUD)
  • IV Drug Usage

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 24 weeks post-treatment

12 weeks post-treatment
Sustained virologic response
16 weeks post-enrollment
Treatment initiation
24 weeks post-treatment
Syringe sharing

Trial Safety

Trial Design

2 Treatment Groups

Enhanced Usual Care
1 of 2
Mobile Tele-HCV Care
1 of 2
Active Control
Experimental Treatment

220 Total Participants · 2 Treatment Groups

Primary Treatment: Mobile Tele-HCV Care · No Placebo Group · N/A

Mobile Tele-HCV Care
Other
Experimental Group · 1 Intervention: Mobile Tele-HCV Care · Intervention Types: Other
Enhanced Usual Care
Other
ActiveComparator Group · 1 Intervention: Enhanced Usual Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks post-treatment
Closest Location: Mobile Study Van · Keene, NH
Photo of new hampshire 1Photo of new hampshire 2Photo of new hampshire 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Hepatitis C
0 CompletedClinical Trials

Who is running the clinical trial?

University of VermontOTHER
252 Previous Clinical Trials
3,741,424 Total Patients Enrolled
1 Trials studying Hepatitis C
Tufts UniversityOTHER
235 Previous Clinical Trials
557,508 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterOTHER
479 Previous Clinical Trials
2,523,037 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,201 Previous Clinical Trials
5,609,934 Total Patients Enrolled
41 Trials studying Hepatitis C
19,667 Patients Enrolled for Hepatitis C
Baystate Medical CenterLead Sponsor
60 Previous Clinical Trials
42,494 Total Patients Enrolled
Better Life Partners IncUNKNOWN
University of New HampshireOTHER
13 Previous Clinical Trials
105,099 Total Patients Enrolled
Thomas J Stopka, PhD, MHSPrincipal InvestigatorTufts University
Peter D Friedmann, MD, MPHPrincipal InvestigatorBaystate Medical Center
4 Previous Clinical Trials
760 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a resident of one of the 10 study counties in NH and VT, and plans to remain in the study region for the next 12 months.
You are willing to be assigned to a treatment group and to be followed over a 12-month period.
You have not previously been treated for HCV.\n
You speak English.\n
You are willing to provide releases to access your medical records to a qualified healthcare provider.
You will provide names and contact information of at least 3 persons for re-contact purposes.
You must be between the ages of 18 and 55 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.