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

Opioid-use Disorder Clinical Trial

— iRaPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531670
• Other study ID #: E20-0596
• Secondary ID: 1R21DA051934-01A
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: September 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention Program
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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

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.

Locations

Country	Name	City	State
United States	Yale Clinical and Community Research	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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