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Patient Navigation & Counseling for HIV Prevention and Hepatitis C (M2HepPrEP Trial)

N/A
Recruiting
Led By Julie Bruneau, M.D.
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving services at an opioid agonist therapy clinic or a syringe access program
Age between 18-64 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

M2HepPrEP Trial Summary

This triallooks at two different ways to give PrEP & HCV treatment to people who inject drugs to determine which is better. Participants will be randomly assigned to one of two groups.

Who is the study for?
This trial is for individuals aged 18-64 who inject drugs, are HIV negative, and can commit to an 18-month follow-up. They must live nearby, consent to the study's terms, use contraception if applicable, speak English or French depending on location, and be clients at opioid therapy clinics or syringe programs. Exclusions include severe medical or mental conditions that affect safe participation or informed consent ability.Check my eligibility
What is being tested?
The study aims to find the best way to deliver PrEP for HIV prevention and Hepatitis C treatment among people who inject drugs. Participants will either receive integrated care onsite or be referred offsite for specialized care. The effectiveness of these two strategies will be compared.See study design
What are the potential side effects?
While specific side effects are not listed in this summary, potential side effects may arise from medications used in PrEP (Pre-exposure Prophylaxis) and HCV (Hepatitis C Virus) treatments which typically include nausea, headache, fatigue, and possible liver-related issues.

M2HepPrEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently getting help at a clinic for opioid use or a needle exchange program.
Select...
I am between 18 and 64 years old.

M2HepPrEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hepatitis C
Sustained PrEP adherence
Secondary outcome measures
Behavioral disinhibition
HCV Incidence
Long-term sustained PrEP Adherence
+2 more

M2HepPrEP Trial Design

2Treatment groups
Experimental Treatment
Group I: On-site Integrated Care with Adherence CounselingExperimental Treatment1 Intervention
Participants randomized to the on-site integrated care with adherence counselling arm will be prescribed pre-exposure prophylaxis (PrEP) (Truvada®) and, if indicated, Hepatitis C (HCV) treatment (Epclusa®) at the OAT clinic or SAP from which they were recruited. In addition to PrEP and, if indicated, HCV care, participants in the on-site integrated care arm will receive any required health care services as per local standard of care. Addiction treatment, OAT, and mental health services will be provided, if necessary and available. Participants recruited at syringe access programs (SAP) will be offered addiction counseling and treatment, including OAT when in the integrated care arm in addition to site standard of care.
Group II: Off-site Referral to Specialized Care with Patient NavigationExperimental Treatment1 Intervention
Participants randomized to the off-site referral to specialized care and patient navigation group will be linked to primary care for PrEP and, if necessary, HCV treatment by a patient navigator. Given the replicated success of the AntiRetroviral Treatment Access Study (ARTAS) intervention regarding linking HIV-infected individuals to HIV primary care, we adapted ARTAS to facilitate people who inject drugs linkage with PrEP and, if necessary, HCV treatment services. Participants in the off-site care arm will be prescribed PrEP and, if necessary, HCV treatment by their off-site physician. All necessary care will also be provided to participants by their off-site physician. Off-site physicians will be notified that if their patients are placed on a waiting list, unable to afford, or are otherwise unable to immediately access PrEP or HCV treatment, Truvada® and Epclusa® are available to participants of the M2HepPrEP study immediately and free of charge.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adherence Counseling
2011
Completed Phase 4
~1310

Find a Location

Who is running the clinical trial?

University of MiamiOTHER
897 Previous Clinical Trials
408,759 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,053 Previous Clinical Trials
1,330,037 Total Patients Enrolled
Université de SherbrookeOTHER
290 Previous Clinical Trials
68,445 Total Patients Enrolled

Media Library

ARTAS Adapted Patient Navigation Clinical Trial Eligibility Overview. Trial Name: NCT03981445 — N/A
Opioid Use Disorder Research Study Groups: On-site Integrated Care with Adherence Counseling, Off-site Referral to Specialized Care with Patient Navigation
Opioid Use Disorder Clinical Trial 2023: ARTAS Adapted Patient Navigation Highlights & Side Effects. Trial Name: NCT03981445 — N/A
ARTAS Adapted Patient Navigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03981445 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~44 spots leftby Sep 2024