Nurse Practitioner–Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.058 | 0.047 |
| Meta-epidemiology (narrow) | 0.008 | 0.004 |
| Meta-epidemiology (broad) | 0.012 | 0.007 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.006 | 0.006 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.011 |
| Insufficient payload (model declined to judge) | 0.092 | 0.016 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".