Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531670
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-08-25
Brief Title:
Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iRaPID
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 designwill 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 httpcfirguideorg 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
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 httpcfirguideorg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21DA051934-01A1 | NIH | None | httpsreporternihgovquickSearch1R21DA051934-01A1 |