Nurse Practitioner-Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial.

Background: The ongoing volatile opioid epidemic remains a significant public health concern, alongside continued outbreaks of HIV and hepatitis C virus among people who inject drugs. The limited access to and scale-up of medications for opioid use disorder (MOUD) among people who inject drugs, coupled with multilevel 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 people who inject drugs (iRaPID) that incorporates same-day PrEP and MOUD for this population.

Objective: The primary objective of this pilot study is to assess the feasibility and acceptability of the program and evaluate its preliminary efficacy on PrEP and MOUD uptake for a future randomized controlled trial (RCT). We also aim to explore information on the implementation of the program in a real-world setting using a type I hybrid implementation trial design.

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 and evaluate its preliminary efficacy on PrEP and MOUD uptake in a pilot RCT. The enrolled 50 people who inject drugs will be randomized (1:1) to either iRaPID or treatment as usual (TAU). Behavioral assessments will occur at baseline, and at 1, 3, and 6 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 people who inject drugs. 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 people who inject drugs who have had minimal access to evidence-based prevention.

Trial Registration: ClinicalTrials.gov NCT04531670; https://clinicaltrials.gov/ct2/show/NCT04531670.

International Registered Report Identifier (irrid): DERR1-10.2196/42585.