Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 9, 2022
Date Accepted: Sep 24, 2022
Nurse Practitioner-Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Background:
The ongoing volatile opioid epidemic remains a significant public health concern, alongside continued outbreaks of HIV and HCV among people who inject drugs (PWID). The limited access to and scale-up of medications for opioid use disorder (MOUD) among PWID, coupled with multi-level barriers to pre-exposure prophylaxis (PrEP) uptake, makes it imperative to integrate evidence-based risk reduction and HIV prevention strategies in innovative ways. To address this need, we developed an integrated rapid access to HIV prevention program for PWID (iRaPID) that incorporates same-day PrEP and MOUD for PWID.
Objective:
This paper describes our ongoing protocol, including its aims, design, framework, and evaluation plan.
Methods:
Using a Type I hybrid implementation trial design, we are pilot-testing the nurse practitioner-led iRaPID program while exploring information on its implementation in a real-world setting. Specifically, we will assess the feasibility and acceptability of the iRaPID program as well as evaluate its preliminary efficacy on PrEP and MOUD uptake in a pilot, randomized controlled trial (RCT). The enrolled 50 PWID will be randomized (1:1) to either iRaPID or treatment as usual (TAU). Behavioral assessments will occur at baseline, one, three, and six months. Additionally, we will conduct a process evaluation of the delivery and implementation of the iRaPID program to collect information for future implementation.
Results:
Recruitment began in July 2021 and was completed in August 2022. Data collection is planned through February 2023. The Institutional Review Boards at Yale University and the University of Connecticut approved this study (2000028740).
Conclusions:
This prospective pilot study will test a nurse practitioner-led, integrated HIV prevention program that incorporates same-day PrEP and MOUD for PWID. This low-threshold protocol delivers integrated prevention via one-stop shopping under the direction of nurse practitioners. iRaPID seeks to overcome barriers to delayed PrEP and MOUD initiation, which is crucial for PWID who have had minimal access to evidence-based prevention. Clinical Trial: ClinicalTrials.gov NCT04531670
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