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SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs (SHAPE)

Primary Purpose

HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIRI Checklist
Enhanced Peer Recovery Coach
SIRI Checklist + Enhanced Peer Recovery Coach
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • We will include 60 PWUD with serious injection related infections (SIRI) who are HIV negative, ≥ 18 years old, have opioid use disorder (OUD) and receiving care at UAB Hospital

Exclusion Criteria:

  • We will exclude those unable to provide informed consent due to acute illness or intoxication, those who don't have OUD, and those who are HIV positive in order to inform HIV prevention interventions.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

SIRI Checklist

Enhanced Peer Recovery Coach

SIRI Checklist + Enhanced Peer Recovery Coach

Standard of Care

Arm Description

A standardized checklist of clinical items to review by the attending hospitalist with participants.

Participants will receive the addiction medicine protocol plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.

A standardized checklist of clinical items to review by the attending hospitalist with participants. Participants will receive the addiction medicine protocol plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.

Participants will receive the stand hospital care while in-patient.

Outcomes

Primary Outcome Measures

Acceptability Assessment
We will conduct exit interviews to assess provider perspectives of SIRI Checklist. We will query addiction, infectious diseases, and primary providers using a standard survey. Open-ended questions will solicit feedback on specific aspects of the checklist or delivery that need to be addressed, edited, or removed before a subsequent randomized controlled study. We will conduct a 3 month follow up survey of participants to assess use of PrEP, addiction treatment, and healthcare utilization.
Feasibility Assessment
We will quantify participants who meet study criteria, consent, have documentation of the SIRI checklist in provider notes, initiate MOUD and/or PrEP in the hospital, and complete exit interviews in order to assess how feasible the intervention is.

Secondary Outcome Measures

Number of prescriptions for PrEP (pre-exposure prophylaxis)
The study team will abstract documentation in the electronic medical record of prescription for PrEP up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system.
Number of prescription for medications for opioid use disorder (MOUD)
The study team will abstract documentation in the electronic medical record of any prescription for MOUD up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system.
Number of outpatient visit(s)attended related to HIV and/or addiction services following hospitalization.
The study team will abstract documentation of any outpatient visit(s) related to HIV and/or addiction services following hospitalization. Data extraction will be limited to services provided in the UAB health system.

Full Information

First Posted
July 13, 2022
Last Updated
November 3, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05480956
Brief Title
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
Acronym
SHAPE
Official Title
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting injectable agents. The central hypothesis is that hospital-based care models can successfully engage rural and Southern (PWUD) in effective addiction treatment and infection prevention. The activities in this study will be foundational to Ending the HIV epidemic in rural states.
Detailed Description
Aim 1: We will conduct a prospective study of 60 PWUD hospitalized at UAB. Using a standardized survey, we will elicit HIV risk behaviors, substance use, and HIV-related stigma. We will use the 14-item Behavioral Risk Assessment for Infectious Diseases (BRAID) scale, which queries drug use and sexual behaviors while using drugs. We will also collect clinical and patient reported data related to infections (bacterial, viral), PrEP use, HCV treatment, and medication for opioid use disorder (MOUD). We will query perception of HIV risk, PrEP awareness, and interest. Surveys will be completed electronically in private hospital rooms to reduce social desirability bias. Aim 2: We will conduct surveys with 60 PWUD hospitalized at UAB to evaluate attitudes and preferences toward opioid use disorder (OUD) treatment and HIV prevention, including long-acting injectable formulations. We will explore interest and preferences related to hospital initiation of each medication. Each session will include open-ended questions on barriers, such as stigma, and opportunities for increasing evidence-based care including HIV prevention and addiction treatment. Aim 3: The SIRI Checklist will build on the existing standard of care for SIRI, Addiction Medicine and ID consultation, by adding a standardized reminder to offer MOUD, PrEP, and arrange appropriate community-based care with both Addiction and ID providers. SIRI Checklist will be inspired by the iCARE checklist, developed for endocarditis in PWID, but will be applicable for all PWUD and will incorporate HIV prevention education and linkage to care, including Hepatitis C (HCV) treatment. The checklist will be integrated into the provider's documentation using a smartphrase text for ease of use and standardization. Of the 60 participants we will randomize them to SIRI checklist (15), SIRI checklist plus enhanced Peer Recovery Coach (15), enhanced Peer Recovery Coach (15), or standard of care (15).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIRI Checklist
Arm Type
Experimental
Arm Description
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Arm Title
Enhanced Peer Recovery Coach
Arm Type
Experimental
Arm Description
Participants will receive the addiction medicine protocol plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
Arm Title
SIRI Checklist + Enhanced Peer Recovery Coach
Arm Type
Experimental
Arm Description
A standardized checklist of clinical items to review by the attending hospitalist with participants. Participants will receive the addiction medicine protocol plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants will receive the stand hospital care while in-patient.
Intervention Type
Behavioral
Intervention Name(s)
SIRI Checklist
Intervention Description
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Peer Recovery Coach
Intervention Description
Participants will receive the addiction medicine standard of care plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
Intervention Type
Behavioral
Intervention Name(s)
SIRI Checklist + Enhanced Peer Recovery Coach
Intervention Description
A standardized checklist of clinical items to review by the attending hospitalist with participants. Participants will receive the addiction medicine standard of care plus peer recovery coaching beginning while hospitalized and continuing for up to 1 month after randomization. As part of this study, Peer recovery coaches will initiate contact with patients weekly in person during the hospitalization and at the time of hospital discharge. The enhanced part of the peer coach is the post-hospital follow-up. Following discharge, contact will continue weekly in person, by phone, and/or via text messaging based on the participant's preferences for 1 month.
Primary Outcome Measure Information:
Title
Acceptability Assessment
Description
We will conduct exit interviews to assess provider perspectives of SIRI Checklist. We will query addiction, infectious diseases, and primary providers using a standard survey. Open-ended questions will solicit feedback on specific aspects of the checklist or delivery that need to be addressed, edited, or removed before a subsequent randomized controlled study. We will conduct a 3 month follow up survey of participants to assess use of PrEP, addiction treatment, and healthcare utilization.
Time Frame
From enrollment to 3 month post-enrollment
Title
Feasibility Assessment
Description
We will quantify participants who meet study criteria, consent, have documentation of the SIRI checklist in provider notes, initiate MOUD and/or PrEP in the hospital, and complete exit interviews in order to assess how feasible the intervention is.
Time Frame
From enrollment to 3 months post-enrollment
Secondary Outcome Measure Information:
Title
Number of prescriptions for PrEP (pre-exposure prophylaxis)
Description
The study team will abstract documentation in the electronic medical record of prescription for PrEP up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system.
Time Frame
Enrollment until 3 months post-enrollment.
Title
Number of prescription for medications for opioid use disorder (MOUD)
Description
The study team will abstract documentation in the electronic medical record of any prescription for MOUD up to 3 months post-enrollment. Data extraction will be limited to services provided in the UAB health system.
Time Frame
Enrollment until 3 months post-enrollment.
Title
Number of outpatient visit(s)attended related to HIV and/or addiction services following hospitalization.
Description
The study team will abstract documentation of any outpatient visit(s) related to HIV and/or addiction services following hospitalization. Data extraction will be limited to services provided in the UAB health system.
Time Frame
Enrollment until 3 months post-enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will include 60 PWUD with serious injection related infections (SIRI) who are HIV negative, ≥ 18 years old, have opioid use disorder (OUD) and receiving care at UAB Hospital Exclusion Criteria: We will exclude those unable to provide informed consent due to acute illness or intoxication, those who don't have OUD, and those who are HIV positive in order to inform HIV prevention interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariel Parman, MPH
Phone
205-996-6337
Email
marielparman@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bernadette Johnson
Phone
205-934-7329
Email
bajohnson@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariel Parman, MPH
Phone
205-996-6337
Email
marielparman@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs

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