Patient Navigation & Counseling for HIV Prevention and Hepatitis C

(M2HepPrEP Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Valérie Martel-Laferrière, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.

Research Team

Julie Bruneau, M.D.

Principal Investigator

Université de Montréal

Lisa R Metsch, Ph.D

Principal Investigator

Columbia University

Daniel Feaster, Ph.D

Principal Investigator

University of Miami

Valérie Martel-Laferrière, MD

Principal Investigator

Université de Montréal

Eligibility Criteria

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.

Inclusion Criteria

HIV negative

Complete a medical release form

I am currently getting help at a clinic for opioid use or a needle exchange program.

Exclusion Criteria

I am allergic or cannot take one of the study's drugs.

I am HIV-positive or have symptoms of an acute HIV infection.

Disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that preclude safe participation in the study or ability to provide fully informed consent

Treatment Details

Interventions

• Adherence Counseling (Behavioral Intervention)
• ARTAS Adapted Patient Navigation (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: On-site Integrated Care with Adherence Counseling Experimental Treatment 1 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 Navigation Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Irving Medical Center New York, NY

Miami Miami, FL

Montreal Montreal, Canada

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1529

Patients Recruited

2,832,000+

University of Miami

Collaborator

Trials

976

Patients Recruited

423,000+

Weill Medical College of Cornell University

Collaborator

Trials

1103

Patients Recruited

1,157,000+

Université de Sherbrooke

Collaborator

Trials

317

Patients Recruited

79,300+

Simon Fraser University

Collaborator

Trials

59

Patients Recruited

12,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2658

Patients Recruited

3,409,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Patients Recruited

143,000+

Université de Montréal

Collaborator

Trials

223

Patients Recruited

104,000+