Clinical trial NCT04531670: Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program
Official title: Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention Program
Opioid-use Disorder
Keywords: People who inject drugs
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - participants screened
timeFrame: 6 months
measure: Feasibility - participants recruited
timeFrame: 6 months
measure: Feasibility - participants randomized
timeFrame: 6 months
measure: Feasibility - participants retained
timeFrame: 6 months
measure: Feasibility - treatment adherence
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Uptake of PrEP and OAT
timeFrame: 6 month
measure: Adherence to PrEP
timeFrame: 6 months
measure: Persistence on PrEP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Clinical and Community Research
state: Connecticut
Study officials:
References:
citation: 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.
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.
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.
citation: 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.