Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program

Not Applicable

Completed

• Conditions: Opioid-use Disorder; HIV Prevention Program
• Interventions: Behavioral: iRaPID; Other: Standard of Care

• Registration Number: NCT04531670
• Lead Sponsor: University of Connecticut

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2021-07-26
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

PWID

1. Age ≥18 years
2. HIV-negative
3. Reporting injection drug use (past 3 months)
4. Substantial ongoing risk for HIV acquisition
5. OUD based on the DSM-V criteria

Stakeholders

1. Age ≥18 years
2. APNs, patient navigators, counselors, and administrators who reflect the range of characteristics of staff members that are involved in HIV care to PWID

Exclusion Criteria

PWID and stakeholders

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to provide informed consent
2. Unable to read and understand English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iRaPID	iRaPID	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
Standard of Care	Standard of Care	PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.

Primary Outcome Measures

Name	Time	Method
Feasibility - participants randomized	6 months	The number of participants randomized will be used as a measurement of feasibility
Feasibility - participants retained	6 months	The number of participants retained will be used as a measurement of feasibility
Feasibility - participants screened	6 months	The number of participants screened will be used as a measure of feasibility
Feasibility - participants recruited	6 months	The number of participants recruited will be used as a measurement of feasibility
Feasibility - treatment adherence	6 months	The number of participants that adhere to treatment will be used as a measurement of feasibility
Acceptability	6 months	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
Uptake of PrEP and OAT	6 month	PrEP uptake proportion at 6-month follow-up will be estimated and compared using linear contrast statement in SAS.
Adherence to PrEP	6 months	Adherence to PrEP will be measured using the visual analogue scale and dried blood spots
Persistence on PrEP	6 months	Persistence on PrEP will be measured by collecting information on refilled within 30 days after exhausting PrEP from previous fill data

Trial Locations

Locations (1)

Yale Clinical and Community Research; 🇺🇸 New Haven, Connecticut, United States