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

NCT04531670 | Completed DMC

• 2 other identifiers: E20-05961R21DA051934-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Prevention Program; Opioid-use Disorder

Keywords

People who inject drugs

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

iRaPID

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

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

iRaPID

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale Clinical and Community Research

New Haven, Connecticut, 06520, United States

Location

Related Publications (4)

• 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.

  PMID: 22310560 BACKGROUND

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 27189233 BACKGROUND

• 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.

  PMID: 36222826 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: July 26, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)