HIV InfectionsSHAPENCT05480956

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

A study testing SIRI Checklist, Enhanced Peer Recovery Coach and SIRI Checklist + Enhanced Peer Recovery Coach in people with HIV Infections and Opioid-Related Disorders, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
What is being tested?: SIRI Checklist, Enhanced Peer Recovery Coach and SIRI Checklist + Enhanced Peer Recovery Coach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2022to 1 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35222

Other trials in United States

About this study

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.

Read the 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).

Conditions: HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
Being tested: SIRI Checklist, Enhanced Peer Recovery Coach, SIRI Checklist + Enhanced Peer Recovery Coach
Medical subject headings: HIV Infections, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SIRI ChecklistBehavioural
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Enhanced Peer Recovery CoachBehavioural
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.
SIRI Checklist + Enhanced Peer Recovery CoachBehavioural
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.

Study groups in NCT05480956
Study group	Role	What they receive
SIRI Checklist	Experimental	A standardized checklist of clinical items to review by the attending hospitalist with participants. Receives: Behavioral: SIRI Checklist
Enhanced Peer Recovery Coach	Experimental	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. Receives: Behavioral: Enhanced Peer Recovery Coach
SIRI Checklist + Enhanced Peer Recovery Coach	Experimental	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. Receives: Behavioral: SIRI Checklist + Enhanced Peer Recovery Coach
Standard of Care	No intervention	Participants will receive the stand hospital care while in-patient.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From enrollment to 3 month post-enrollment
Feasibility Assessment
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.
Measured: From enrollment to 3 months post-enrollment

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: Enrollment until 3 months post-enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 20221 Jul 2025

First posted29 Jul 2022
Study start11 Oct 2022
Primary completion1 Jul 2025
Study completion1 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05480956
Sponsor's protocol ID: IRB-300009134
Other IDs: UAB
Acronym: SHAPE
Status last verified: May 2026
First submitted: 13 Jul 2022
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Baldwin M, Jeziorski M, Parman M, Gagnon K, Nichols MA, Bradford D, Crockett K, Eaton E. A Study Protocol to Increase Engagement in Evidence Based Hospital and Community Based Care Using a Serious Injection Related Infections (SIRI) Checklist and Enhanced Peer for Hospitalized PWID (ShaPe). Res Sq [Preprint]. 2023 Jun 7:rs.3.rs-2546488. doi: 10.21203/rs.3.rs-2546488/v1.
PubMed 37333109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
ClinicalTrials.gov ID: NCT05480956
Acronym / sponsor ID: SHAPE / IRB-300009134
Conditions: HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 11 Oct 2022 (actual)
Primary completion: 1 Jul 2025 (actual)
Study completion: 1 Jul 2025 (actual)
First posted: 29 Jul 2022 (actual)
Results: Posted 19 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim 1:

Aim 2:

Aim 3:

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
SIRI Checklist	Experimental	Behavioral: SIRI ChecklistA standardized checklist of clinical items to review by the attending hospitalist with participants.
Enhanced Peer Recovery Coach	Experimental	Behavioral: Enhanced Peer Recovery CoachParticipants 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	Experimental	Behavioral: SIRI Checklist + Enhanced Peer Recovery CoachA 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.
Standard of Care	No intervention	–Participants will receive the stand hospital care while in-patient.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SIRI ChecklistA standardized checklist of clinical items to review by the attending hospitalist with participants.	Behavioural	SIRI Checklist
Enhanced Peer Recovery CoachParticipants 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.	Behavioural	Enhanced Peer Recovery Coach
SIRI Checklist + Enhanced Peer Recovery CoachA 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.	Behavioural	SIRI Checklist + Enhanced Peer Recovery Coach

Primary outcome

Acceptability Assessment
Time frame: From enrollment to 3 month post-enrollment
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
Time frame: From enrollment to 3 months post-enrollment
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.

3 secondary outcomes

Number of Prescriptions for PrEP (Pre-exposure Prophylaxis)
Time frame: Enrollment until 3 months post-enrollment.
Number of Prescription for Medications for Opioid Use Disorder (MOUD)
Time frame: Enrollment until 3 months post-enrollment.
Number of Outpatient Visit(s)Attended Related to HIV and/or Addiction Services Following Hospitalization.
Time frame: Enrollment until 3 months post-enrollment.

Results and safety

Results posted to the registry on 19 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	15	9
SIRI Checklist	15	9
Enhanced Peer Recovery Coach	15	11
SIRI Checklist + Enhanced Peer Recovery Coach	15	10

Primary outcome: Acceptability Assessment

Time frame: From enrollment to 3 month post-enrollment. Count of participants. Unit: Participants

Measure	All Randomized Participants n = 60	Peer Recovery Coach & SIRI Checklist n = 15	SIRI Checklist Only n = 15	Peer Recovery Coach Only n = 15	Standard of Care n = 15
Completed Follow Up	42	10	10	11	11
Lost to follow up	16	4	5	3	4
Deceased prior to follow-up	2	1	0	1	0

Population analysed: 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.

Primary outcome: Feasibility Assessment

Time frame: From enrollment to 3 months post-enrollment. Count of participants. Unit: Participants

Measure	All Screened n = 657	Eligible Patients n = 161
No OUD (opioid use disorder)	45	0
No SIRI (Severe Injection-Related Infections)	31	0
No OUD or SIRI	24	0
HIV+	12	0
No IVDU (IV Drug Use)	216	0
No OUD or IVDU	143	0
Unable to provide IC (Informed Consent)	6	0
Incarcerated	14	0

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of 3 month follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 15 (0%)	0 of 15 (0%)	0 of 15
SIRI Checklist	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Enhanced Peer Recovery Coach	0 of 15 (0%)	0 of 15 (0%)	1 of 15
SIRI Checklist + Enhanced Peer Recovery Coach	0 of 15 (0%)	0 of 15 (0%)	1 of 15

Limitations and caveats (from the sponsor): This pilot included a nested feasibility and acceptability study, which if conducted separately may have yielded additional insights. Also, the absence of PrEP participants limited implementation findings. Finally, even though though the SIRI checklist is low-fidelity, the study occurred in a resource-rich urban academic center with established peer recovery supports, which may limit generalizability to lower-resource settings unable to support embedded Peer Resource Specialists.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37333109Baldwin M, Jeziorski M, Parman M, Gagnon K, Nichols MA, Bradford D, Crockett K, Eaton E. A Study Protocol to Increase Engagement in Evidence Based Hospital and Community Based Care Using a Serious Injection Related Infections (SIRI) Checklist and Enhanced Peer for Hospitalized PWID (ShaPe). Res Sq [Preprint]. 2023 Jun 7:rs.3.rs-2546488. doi: 10.21203/rs.3.rs-2546488/v1.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability Assessment (time frame: From enrollment to 3 month post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480956, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.