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Completed

NCT Number: NCT04531670

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

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).

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Key information

Conditions

HIV Prevention Program Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Clinical and Community Research

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PWID

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

Stakeholders

  • Age ≥18 years
  • 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:

  • Unable to provide informed consent
  • Unable to read and understand English

Treatment and study plan

iRaPID

Behavioral

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

Other

PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.

Primary outcomes

  1. Feasibility - participants screened

    Time frame: 6 months

    The number of participants screened will be used as a measure of feasibility

  2. Feasibility - participants recruited

    Time frame: 6 months

    The number of participants recruited will be used as a measurement of feasibility

  3. Feasibility - participants randomized

    Time frame: 6 months

    The number of participants randomized will be used as a measurement of feasibility

  4. Feasibility - participants retained

    Time frame: 6 months

    The number of participants retained will be used as a measurement of feasibility

  5. Feasibility - treatment adherence

    Time frame: 6 months

    The number of participants that adhere to treatment will be used as a measurement of feasibility

  6. Acceptability

    Time frame: 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

  7. Uptake of PrEP and OAT

    Time frame: 6 month

    PrEP uptake proportion at 6-month follow-up will be estimated and compared using linear contrast statement in SAS.

  8. Adherence to PrEP

    Time frame: 6 months

    Adherence to PrEP will be measured using the visual analogue scale and dried blood spots

  9. Persistence on PrEP

    Time frame: 6 months

    Persistence on PrEP will be measured by collecting information on refilled within 30 days after exhausting PrEP from previous fill data

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: iRaPID

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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