This is a pilot study of an integrated rapid access HIV prevention program for People who inject drugs (PWID) called iRaPID. The program incorporates same-day access to Pre-exposure Prophylaxis (PrEP) and Opioid Agonist Therapy (OAT).
A Hybrid type 1 implementation science design,will be used to pilot test the APN-led iRaPID program while exploring information on its implementation at multiple time points through the study. The hybrid type 1 pilot trial provides an implementation heuristic to assess potential research questions, perhaps more comprehensively, accurately and certainly earlier than could be achieved in a sequential 'intervention-then-preliminary-pilot study' strategy. In this hybrid type 1 pilot trial, the RCT will be utilized to: * Examine feasibility and acceptability among PWID and clinical stakeholders for an adapted APN-delivered, rapid HIV prevention program for PWID (iRaPID) that integrates same-day PrEP and OAT. * Estimate the preliminary efficacy of PrEP and OAT uptake in a pilot randomized controlled trial of the iRaPID vs. treatment as usual strategy in PWID without HIV. To assess future scale-up factors, the Consolidated Framework for Implementation Research (CFIR) will be utilized with the nominal group technique (NGT). It is a conceptual framework developed to guide the assessment of multilevel implementation contexts. The CFIR framework was selected because it provides a structured menu of constructs associated with effective implementation. It consists of 5 domains with 39 underlying constructs. As recommended by Damschroder, in this study 8 CFIR constructs based on the relevancy will be measured. During the NGT, participants will be asked questions related to the multi-level implementation factors that will be based on the sample guide available on http://cfirguide.org but tailored for PWID. After posing each question, participants silently generate individual ideas. Then, using a round-robin elicitation process, each person contributes ideas that are recorded visually. They then engage in group discussion to clarify and evaluate the ideas. Items are then grouped by consensus with duplicate items removed. Then, each participant casts three votes on items as they deem them important. Votes are immediately tallied, ranked based on total number of votes, and the facilitator leads a final discussion to review the results. Sessions will take 60 minutes and be audio-recorded and transcribed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
50
Participants randomized to the iRaPID program will receive: a) same-day access to PrEP and OAT and educational counseling by the APN; b) safety-check phone calls/SMS; c) follow-up phone call/SMS; and d) clinical visit at Day 30
PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.
Yale Clinical and Community Research
New Haven, Connecticut, United States
Feasibility - participants screened
The number of participants screened will be used as a measure of feasibility
Time frame: 6 months
Feasibility - participants recruited
The number of participants recruited will be used as a measurement of feasibility
Time frame: 6 months
Feasibility - participants randomized
The number of participants randomized will be used as a measurement of feasibility
Time frame: 6 months
Feasibility - participants retained
The number of participants retained will be used as a measurement of feasibility
Time frame: 6 months
Feasibility - treatment adherence
The number of participants that adhere to treatment will be used as a measurement of feasibility
Time frame: 6 months
Acceptability
Acceptability will be measured using a 10-item acceptability rating profile. Acceptability will be based on descriptive statistics from the acceptability measures (score ≥70) and analysis of qualitative data, which will be done using thematic analysis
Time frame: 6 months
Uptake of PrEP and OAT
PrEP uptake proportion at 6-month follow-up will be estimated and compared using linear contrast statement in SAS.
Time frame: 6 month
Adherence to PrEP
Adherence to PrEP will be measured using the visual analogue scale and dried blood spots
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Time frame: 6 months
Persistence on PrEP
Persistence on PrEP will be measured by collecting information on refilled within 30 days after exhausting PrEP from previous fill data
Time frame: 6 months