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Mobile Hepatitis C Intervention for Hepatitis C (DISCERNNE Trial)
N/A
Recruiting
Led By Peter D Friedmann, MD, MPH
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post-treatment
Awards & highlights
DISCERNNE Trial Summary
This trial will test a mobile intervention for hepatitis C virus (HCV) that includes access to syringes in order to reduce syringe sharing behavior and improve uptake of HCV testing and treatment in rural northern New England.
Who is the study for?
This trial is for English-speaking adults over 18 living in certain NH and VT counties, who have Hepatitis C from injection drug use. They must have health insurance covering HCV meds (assistance available), not been treated for HCV before, and not be pregnant or planning pregnancy. Participants should plan to stay local for a year and agree to random assignment and follow-ups.Check my eligibility
What is being tested?
The study tests a mobile telehealth service providing hepatitis C testing/treatment alongside syringe access to reduce syringe sharing among rural opioid users. It compares this new approach with enhanced usual care to see if it can improve health outcomes in these communities.See study design
What are the potential side effects?
While specific side effects are not detailed here, typical treatments for Hepatitis C may include headaches, fatigue, nausea, insomnia, low blood count (anemia), mood changes, rash or itching. Side effects of the interventions will be monitored throughout the study.
DISCERNNE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sustained virologic response
Syringe sharing
Treatment initiation
DISCERNNE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Tele-HCV CareExperimental Treatment1 Intervention
Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine
Group II: Enhanced Usual CareActive Control1 Intervention
Referral with care navigation to a local or regional HCV treatment provider
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,189 Total Patients Enrolled
Baystate Medical CenterLead Sponsor
63 Previous Clinical Trials
44,053 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterOTHER
524 Previous Clinical Trials
2,543,119 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney problems or am on dialysis.I can understand and agree to the study's details on my own.My health insurance covers HCV medications.I have never been treated for Hepatitis C.I am 18 years old or older.I have advanced liver disease with symptoms like jaundice, swelling in my abdomen and legs, confusion, or a history of GI bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile Tele-HCV Care
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity for this clinical experiment?
"Affirmative. According to the information present on clinicaltrials.gov, this trial is actively searching for participants since its inception in May 18th 2022 and was last updated July 18th 2022. The study requires 220 people from 2 medical centres for enrolment purposes."
Answered by AI
Are new participants still being accepted in this research project?
"Clinicaltrials.gov indicates that this medical trial is actively recruiting eligible participants, with the initial posting occurring on May 18th 2022 and the last edit being made on July 18th 2022."
Answered by AI
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