Trial Outcomes & Findings for SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs (NCT NCT05480956)
NCT ID: NCT05480956
Last Updated: 2026-08-19
Results Overview
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.
COMPLETED
NA
60 participants
From enrollment to 3 month post-enrollment
2026-08-19
Participant Flow
Participants will be recruited following hospitalization for SIRI at UAB Hospital. Our research coordinator will meet biweekly with the Addiction Medicine social worker and/or nurse practitioner, to identify eligible PWID who express interest in study participation. The research team member will then discuss the study with those who are eligible, and if the participant expresses interest, the informed consent process will be completed.
Inclusion Criteria: We will include 60 PWID with serious injection related infections (SIRI) who are HIV negative, ≥ 18 years old and receiving care at UAB Hospital for each of the three aims. Exclusion Criteria: We will exclude those unable to provide informed consent due to acute illness or intoxication and those who are living with HIV in order to inform HIV prevention interventions. Eligible participants provided written informed consent prior to randomization.
Participant milestones
| Measure |
Standard of Care
Participants will receive the stand hospital care. The standard of care for PWID admitted to UAB Hospital with SIRI includes an Infectious Diseases and Addiction Medicine consultation.
|
SIRI Checklist
The SIRI Checklist will build on the existing standard of care for SIRI by adding a standardized reminder to offer MOUD, HIV risk assessment, and refer to appropriate community-based care. SIRI Checklist was inspired by the iCARE checklist, developed for endocarditis in PWID, but is applicable for all PWID and will incorporate HIV prevention, harm reduction education and linkage to care, including HCV treatment. For participants who are randomized to receive the SIRI checklist, providers will receive instructions on how to insert a 5-item checklist into their documentation using a smart phrase text for ease of use and standardization. Because use of a checklist alone has been shown to change provider behavior, providers will not be required to perform any additional tasks other than daily documentation of the checklist. We anticipate that documentation of evidence-based services using a checklist reminder will increase the likelihood that participants will receive them.
|
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.
|
SIRI Checklist + Enhanced Peer Recovery Coach
The SIRI Checklist will build on the existing standard of care for SIRI by adding a standardized reminder to offer MOUD, HIV risk assessment, and refer to appropriate community-based care.
The intensive peer intervention will include weekly calls to participants for 4 weeks following discharge. If participants do not respond, peers will make 3 attempts to reach participants at their preferred contact number.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
9
|
9
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
Baseline characteristics by cohort
| Measure |
Standard of Care
n=15 Participants
Participants will receive the stand hospital care.
|
SIRI Checklist
n=15 Participants
A standardized checklist of clinical items to review by the attending hospitalist with participants.
|
Enhanced Peer Recovery Coach
n=15 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.
|
SIRI Checklist + Enhanced Peer Recovery Coach
n=15 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 7.13 • n=298 Participants
|
37.8 Years
STANDARD_DEVIATION 8.86 • n=102 Participants
|
38.6 Years
STANDARD_DEVIATION 10.2 • n=400 Participants
|
37.93 Years
STANDARD_DEVIATION 8.37 • n=30 Participants
|
39.03 Years
STANDARD_DEVIATION 8.64 • n=1389 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=298 Participants
|
7 Participants
n=102 Participants
|
7 Participants
n=400 Participants
|
9 Participants
n=30 Participants
|
31 Participants
n=1389 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=298 Participants
|
8 Participants
n=102 Participants
|
8 Participants
n=400 Participants
|
6 Participants
n=30 Participants
|
29 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=298 Participants
|
14 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
14 Participants
n=30 Participants
|
56 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
PRIMARY outcome
Timeframe: From enrollment to 3 month post-enrollmentPopulation: Checklist groups means the checklist only group and Peer + checklist group (This group does not include standard of care nor peer populations). Provider checklist utilized counts the providers that did utilize the checklist that were involved in either of the two checklist groups. Thus, the outcome table describing feasibility is looking at the amount of providers that followed through utilizing the checklist and also looking at feasibility in participants by the amount to complete follow up.
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.
Outcome measures
| Measure |
All Randomized Participants
n=60 Participants
All Randomized Participants
|
Peer Recovery Coach & SIRI Checklist
n=15 Participants
This accounts for 2 out of 4 of the randomization groups. These groups were the only groups which would have had an alternative of standard of care from the perspective of the hospital provider team.
|
SIRI Checklist Only
n=15 Participants
Population of Checklist groups which include the checklist only group and Peer + checklist group. This group does not include standard of care nor peer populations.
|
Peer Recovery Coach Only
n=15 Participants
The Peer Recovery Coach intervention included a certified peer specialist who met with the participants prior to discharge and reached out to them via phone or text message, per participant preference, on discharge. The follow up cadence was a series of weekly follow ups for three months post-discharge, with three attempts each week to reach study participants.
|
Standard of Care
n=15 Participants
The standard of care for PWID at \[BLINDED\] Hospital includes addiction medicine consultation when requested by the primary team, alongside infectious diseases (ID) consultation for cases of infection and other specialty services as needed
|
|---|---|---|---|---|---|
|
Acceptability Assessment
Completed Follow Up
|
42 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
11 Participants
|
|
Acceptability Assessment
Lost to follow up
|
16 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Acceptability Assessment
Deceased prior to follow-up
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From enrollment to 3 months post-enrollmentPopulation: Participants screened include individuals filtered in the EMR through display logic for eligibility review. Through deeper inspection of the EMR, some were determined not to need approach, while others were approached bedside for additional screening. Reasons for ineligibility are documented in this table. Eligible participants met study criteria but may or may not have enrolled and been randomized into the study.
Feasibility will be measured via recruitment and retention of participants, completion of each portion of the intervention (baseline surveys and follow up assessments), and ability to contact patients post-discharge for intensive Peer support and/or completion of follow up assessments. We will also evaluate the ability to extract documentation of the SIRI Checklist and Peer documentation provider notes.
Outcome measures
| Measure |
All Randomized Participants
n=657 Participants
All Randomized Participants
|
Peer Recovery Coach & SIRI Checklist
n=161 Participants
This accounts for 2 out of 4 of the randomization groups. These groups were the only groups which would have had an alternative of standard of care from the perspective of the hospital provider team.
|
SIRI Checklist Only
Population of Checklist groups which include the checklist only group and Peer + checklist group. This group does not include standard of care nor peer populations.
|
Peer Recovery Coach Only
The Peer Recovery Coach intervention included a certified peer specialist who met with the participants prior to discharge and reached out to them via phone or text message, per participant preference, on discharge. The follow up cadence was a series of weekly follow ups for three months post-discharge, with three attempts each week to reach study participants.
|
Standard of Care
The standard of care for PWID at \[BLINDED\] Hospital includes addiction medicine consultation when requested by the primary team, alongside infectious diseases (ID) consultation for cases of infection and other specialty services as needed
|
|---|---|---|---|---|---|
|
Feasibility Assessment
No OUD (opioid use disorder)
|
45 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
No SIRI (Severe Injection-Related Infections)
|
31 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
No OUD or SIRI
|
24 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
HIV+
|
12 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
No IVDU (IV Drug Use)
|
216 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
No OUD or IVDU
|
143 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Unable to provide IC (Informed Consent)
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Incarcerated
|
14 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Discharged before addiction med consult
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Approached, interested, and eligible; but not enrolled
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Declined
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Discharged after Approach
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Unknown eligibility
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Died after approach before consent
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Unable to approach before discharge
|
86 Participants
|
86 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Not followed by addiction medicine
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Branch hospital eligible, not approached
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Feasibility Assessment
Randomized
|
60 Participants
|
60 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrollment until 3 months post-enrollment.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.
Outcome measures
| Measure |
All Randomized Participants
n=15 Participants
All Randomized Participants
|
Peer Recovery Coach & SIRI Checklist
n=15 Participants
This accounts for 2 out of 4 of the randomization groups. These groups were the only groups which would have had an alternative of standard of care from the perspective of the hospital provider team.
|
SIRI Checklist Only
n=15 Participants
Population of Checklist groups which include the checklist only group and Peer + checklist group. This group does not include standard of care nor peer populations.
|
Peer Recovery Coach Only
n=15 Participants
The Peer Recovery Coach intervention included a certified peer specialist who met with the participants prior to discharge and reached out to them via phone or text message, per participant preference, on discharge. The follow up cadence was a series of weekly follow ups for three months post-discharge, with three attempts each week to reach study participants.
|
Standard of Care
The standard of care for PWID at \[BLINDED\] Hospital includes addiction medicine consultation when requested by the primary team, alongside infectious diseases (ID) consultation for cases of infection and other specialty services as needed
|
|---|---|---|---|---|---|
|
Number of Prescriptions for PrEP (Pre-exposure Prophylaxis)
|
0 prescriptions
|
0 prescriptions
|
0 prescriptions
|
0 prescriptions
|
—
|
SECONDARY outcome
Timeframe: Enrollment until 3 months post-enrollment.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.
Outcome measures
| Measure |
All Randomized Participants
n=15 Participants
All Randomized Participants
|
Peer Recovery Coach & SIRI Checklist
n=15 Participants
This accounts for 2 out of 4 of the randomization groups. These groups were the only groups which would have had an alternative of standard of care from the perspective of the hospital provider team.
|
SIRI Checklist Only
n=15 Participants
Population of Checklist groups which include the checklist only group and Peer + checklist group. This group does not include standard of care nor peer populations.
|
Peer Recovery Coach Only
n=15 Participants
The Peer Recovery Coach intervention included a certified peer specialist who met with the participants prior to discharge and reached out to them via phone or text message, per participant preference, on discharge. The follow up cadence was a series of weekly follow ups for three months post-discharge, with three attempts each week to reach study participants.
|
Standard of Care
The standard of care for PWID at \[BLINDED\] Hospital includes addiction medicine consultation when requested by the primary team, alongside infectious diseases (ID) consultation for cases of infection and other specialty services as needed
|
|---|---|---|---|---|---|
|
Number of Prescription for Medications for Opioid Use Disorder (MOUD)
|
11 Prescriptions
|
13 Prescriptions
|
11 Prescriptions
|
9 Prescriptions
|
—
|
SECONDARY outcome
Timeframe: Enrollment until 3 months post-enrollment.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.
Outcome measures
| Measure |
All Randomized Participants
n=15 Participants
All Randomized Participants
|
Peer Recovery Coach & SIRI Checklist
n=15 Participants
This accounts for 2 out of 4 of the randomization groups. These groups were the only groups which would have had an alternative of standard of care from the perspective of the hospital provider team.
|
SIRI Checklist Only
n=15 Participants
Population of Checklist groups which include the checklist only group and Peer + checklist group. This group does not include standard of care nor peer populations.
|
Peer Recovery Coach Only
n=15 Participants
The Peer Recovery Coach intervention included a certified peer specialist who met with the participants prior to discharge and reached out to them via phone or text message, per participant preference, on discharge. The follow up cadence was a series of weekly follow ups for three months post-discharge, with three attempts each week to reach study participants.
|
Standard of Care
The standard of care for PWID at \[BLINDED\] Hospital includes addiction medicine consultation when requested by the primary team, alongside infectious diseases (ID) consultation for cases of infection and other specialty services as needed
|
|---|---|---|---|---|---|
|
Number of Outpatient Visit(s)Attended Related to HIV and/or Addiction Services Following Hospitalization.
|
2 Number of outpatient visit(s) attended
|
8 Number of outpatient visit(s) attended
|
5 Number of outpatient visit(s) attended
|
4 Number of outpatient visit(s) attended
|
—
|
Adverse Events
Standard of Care
SIRI Checklist
Enhanced Peer Recovery Coach
SIRI Checklist + Enhanced Peer Recovery Coach
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ellen Eaton MD, MSPH, Professor of Psychiatry and Behavioral Neurobiology, Professor of Medicine
The University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place