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

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).

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; HIV Prevention Program
• Intervention / Treatment: Behavioral: iRaPID; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Clinical and Community Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Active Comparator: Standard of Care; PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.	Other: Standard of Care; PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - participants screened	The number of participants screened will be used as a measure of feasibility	6 months
Feasibility - participants recruited	The number of participants recruited will be used as a measurement of feasibility	6 months
Feasibility - participants randomized	The number of participants randomized will be used as a measurement of feasibility	6 months
Feasibility - participants retained	The number of participants retained will be used as a measurement of feasibility	6 months
Feasibility - treatment adherence	The number of participants that adhere to treatment will be used as a measurement of feasibility	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	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.	6 month
Adherence to PrEP	Adherence to PrEP will be measured using the visual analogue scale and dried blood spots	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	6 months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
• Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implement Sci. 2016 May 17;11:72. doi: 10.1186/s13012-016-0437-z.
• Khati A, Altice FL, Vlahov D, Eger WH, Lee J, Bohonnon T, Wickersham JA, Maviglia F, Copenhaver N, Shrestha R. Nurse Practitioner-Led Integrated Rapid Access to HIV Prevention for People Who Inject Drugs (iRaPID): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 11;11(10):e42585. doi: 10.2196/42585.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: People who inject drugs
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: E20-0596; 1R21DA051934-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No