Integrated HIV Prevention and HCV Care for PWID

Summary

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.

Conditions

• HIV Prevention
• HCV
• Opioid Use
• Intravenous Drug Usage

Interventions

BEHAVIORAL

ARTAS Adapted Patient Navigation

Patient navigation will provided by trained patient navigators to participants randomized to the off-site referral to specialized care arm. Patient Navigators will actively coordinate and link participants to available clinics and community resources by scheduling appointments, arranging transportation, and assisting the participant with completing any paperwork that a clinic or service agent may require. The intervention will include up to five, 30-45 minute face-to-face meetings between the patient navigator and participant. These meetings will be tailored around each participant's needs. Additionally, the patient navigator assists the participant in identifying and utilizing informal and formal sources of support to move along the PrEP and/or HCV care continuum.The patient navigator will help the participant inform off-site physicians of the trial and of the availability of PrEP and HCV medication, should the physician and patient decide to initiate one or both treatments.

BEHAVIORAL

Adherence Counseling

Counseling for PrEP initiation and adherence and, if necessary, HCV treatment will be provided by the clinical counseling staff of the on-site integrated care arm. Adherence counseling will include, but not be limited to, the indications, advantages, and disadvantages (e.g. side effects) of PrEP and HCV treatment in order to help the participant with his/her decision. The counselor will provide any necessary information to the participants and help them to address health and social needs. If required, the counselor will help the patient and physician with insurance-related issues. Adherence counselling will be carried out in a motivational style. The intervention will include five 30-45 minute face-to-face meetings with the participant and the adherence counselor over 6 months.

Sponsors & Collaborators

• Université de Montréal

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Université de Sherbrooke

  collaborator OTHER

• Simon Fraser University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Lisa R Metsch, Ph.D · Columbia University

• Julie Bruneau, M.D. · Université de Montréal

• Daniel Feaster, Ph.D · University of Miami

• Valérie Martel-Laferrière, MD · Université de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-14

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• United States
• Canada

Study Locations