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

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, 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

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.

Keywords: Adherence counselor; Hepatitis C treatment; Patient navigator; People who inject drugs; Pre-exposure prophylaxis (PrEP).

Conflict of interest statement

JB and VML report receiving study drugs as Gilead Science donations for investigational use. VML reports receiving Gilead Science and Merck funding for research unrelated to this study. JB reports receiving monetary compensation from Gilead Sciences and Abbvie unrelated to this study until 2019. HT reports receiving Gilead Science funding for research unrelated to this study. MEG reports monetary compensations for conferences from Idivior and Gilead Science outside of the submitted work. All other authors have nothing to disclose.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
A Participant screening timeline. B Participant study timeline

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