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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Opioid-Related Disorders; Pre-Exposure Prophylaxis (PrEP)
• Intervention / Treatment: Behavioral: SIRI Checklist; Behavioral: Enhanced Peer Recovery Coach; Behavioral: SIRI Checklist + Enhanced Peer Recovery Coach

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariel Parman, MPH; Phone Number: 205-996-6337; Email: marielparman@uabmc.edu
• Study Contact Backup: Name: Bernadette Johnson; Phone Number: 205-934-7329; Email: bajohnson@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Mariel Parman, MPH; Phone Number: 205-996-6337; Email: marielparman@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIRI Checklist; A standardized checklist of clinical items to review by the attending hospitalist with participants.	Behavioral: SIRI Checklist; A standardized checklist of clinical items to review by the attending hospitalist with participants.
Experimental: Enhanced Peer Recovery Coach; 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.	Behavioral: Enhanced Peer Recovery Coach; 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.
Experimental: SIRI Checklist + Enhanced Peer Recovery Coach; 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.	Behavioral: SIRI Checklist + Enhanced Peer Recovery Coach; 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.
No Intervention: Standard of Care; Participants will receive the stand hospital care while in-patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 3 month post-enrollment
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.	From enrollment to 3 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment until 3 months post-enrollment.
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.	Enrollment until 3 months post-enrollment.
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.	Enrollment until 3 months post-enrollment.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB-300009134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No