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Open Access 01-12-2022 | Care | Study protocol

M²HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

Authors: Valérie Martel-Laferrière, Daniel J. Feaster, Lisa R. Metsch, Bruce R. Schackman, Christine Loignon, Bohdan Nosyk, Hansel Tookes, Czarina N. Behrends, Nelson Arruda, Oluleye Adigun, Marie-Eve Goyer, Michael A. Kolber, Jean-Francois Mary, Allan E. Rodriguez, Iveth G. Yanez, Yue Pan, Rania Khemiri, Lauren Gooden, Aïssata Sako, Julie Bruneau

Published in: Trials | Issue 1/2022

Abstract

Background

Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes.

Methods

The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M²HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated.

Discussion

The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings.

Trial registration

Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.

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Title: M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID
Authors: Valérie Martel-Laferrière
Daniel J. Feaster
Lisa R. Metsch
Bruce R. Schackman
Christine Loignon
Bohdan Nosyk
Hansel Tookes
Czarina N. Behrends
Nelson Arruda
Oluleye Adigun
Marie-Eve Goyer
Michael A. Kolber
Jean-Francois Mary
Allan E. Rodriguez
Iveth G. Yanez
Yue Pan
Rania Khemiri
Lauren Gooden
Aïssata Sako
Julie Bruneau
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Care
Human Immunodeficiency Virus
Hepatitis C
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06085-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

M²HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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