# A Multi-site Multi-Setting RCT of Integrated HIV Prevention and HCV Care for PWID

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $1,217,167

## Abstract

Abstract
The opioid crisis in North America comes with a multitude of health consequences, including HIV and Hepatitis
C (HCV) outbreaks. HIV and HCV are major contributors to morbidity and mortality among persons who inject
drugs (PWID). These infections also bear significant medical costs. While HIV treatment scale-up remains
essential, significant improvements in HIV and HCV prevention and care are required to reduce substantially
the HIV and HCV burden among PWID. Pre-exposure prophylaxis (PrEP) and the HCV cure regimens have
transformative potential to reduce these two co-occurring epidemics. A key question for implementation
research is how to best integrate these pharmacological advances in prevention and care strategies for PWID.
Given the relative dearth of prior research on PrEP among PWID, we critically need to expand our
understanding of the potential role of PrEP for PWID engaged in HCV assessment and treatment. Within this
context, we propose a randomized hybrid effectiveness-implementation trial (n=500) to evaluate two
implementation strategies for PrEP and HCV care integration among PWID: on-site integrated care (PrEP
initiation and HCV treatment) vs. off-site referral with patient navigation to specialized care. HIV-negative PWID
will be recruited from two venues—opioid substitution therapy (OST) venues and syringe exchange programs
(SEPs)—within two North American cities—Miami and Montréal. The cities provide variability in background
health access (Montreal-High Services/Low Barriers versus Miami-Low Services/High Barriers); venues
provide variability in overhead/resources (OTPs-High Resources versus SEPs-Low Resource). There are two
overall aims: 1) To determine if integrated PrEP and HCV treatment offered on-site in treatment and harm
reduction settings results in higher rates of a) sustained PrEP adherence and/or b) HCV cure (primary
outcomes), compared to an off-site referral with patient navigation, and to c) test the contributions of local
environment and venue on primary outcomes, and 2) To evaluate a) the health care utilization impact and the
relative resource use of the on-site integrated care approach compared to the referral with patient navigator
approach and b) the health care resources required to scale up these intervention approaches in the local
environments and settings. Secondary outcomes will include PrEP initiation, use, long-term sustained PrEP
adherence, HCV treatment initiation, risk behavior changes, HCV infection/reinfection, and STD/HIV incidence.
For these secondary outcomes, we also will include a qualitative study to understand the interplay of the
personal, interpersonal, and social contextual factors that may be associated with PrEP adherence and issues
of behavioral compensation over time for PWID. Additional qualitative study will examine facilitators and
barriers to implementation. This two-city by two-venue design will provide crucial information to understand
implementation/dissemination is...

## Key facts

- **NIH application ID:** 10217065
- **Project number:** 5R01DA045713-05
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Julie Bruneau
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,217,167
- **Award type:** 5
- **Project period:** 2017-09-30 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10217065

## Citation

> US National Institutes of Health, RePORTER application 10217065, A Multi-site Multi-Setting RCT of Integrated HIV Prevention and HCV Care for PWID (5R01DA045713-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10217065. Licensed CC0.

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