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SIRI Checklist + Peer Coaching for HIV Prevention in Opioid Users (SHAPE Trial)

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 3 month post-enrollment
Awards & highlights

SHAPE Trial Summary

This trial will develop and test a checklist to increase evidence-based treatment for rural people who use drugs, including long-acting injectable agents. The hypothesis is that hospital-based care models can successfully engage rural people in effective addiction treatment and infection prevention, which is foundational to Ending the HIV epidemic in rural states.

Who is the study for?
This trial is for individuals over 18 with opioid use disorder who are HIV negative and have serious injection-related infections. They must be receiving care at UAB Hospital and able to give informed consent, not excluded due to acute illness or intoxication.Check my eligibility
What is being tested?
The study is testing a SIRI Checklist alone, an Enhanced Peer Recovery Coach alone, and the combination of both interventions. The goal is to improve addiction treatment and prevent infections in rural drug users by using hospital-based care models.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort or stress during recovery coaching sessions.

SHAPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment until 3 months post-enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment until 3 months post-enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability Assessment
Feasibility Assessment
Secondary outcome measures
Number of outpatient visit(s)attended related to HIV and/or addiction services following hospitalization.
Number of prescription for medications for opioid use disorder (MOUD)
Number of prescriptions for PrEP (pre-exposure prophylaxis)

SHAPE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: SIRI Checklist + Enhanced Peer Recovery CoachExperimental Treatment1 Intervention
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.
Group II: SIRI ChecklistExperimental Treatment1 Intervention
A standardized checklist of clinical items to review by the attending hospitalist with participants.
Group III: Enhanced Peer Recovery CoachExperimental Treatment1 Intervention
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.
Group IV: Standard of CareActive Control1 Intervention
Participants will receive the stand hospital care while in-patient.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,984 Total Patients Enrolled

Media Library

SIRI Checklist Clinical Trial Eligibility Overview. Trial Name: NCT05480956 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: SIRI Checklist + Enhanced Peer Recovery Coach, Standard of Care, SIRI Checklist, Enhanced Peer Recovery Coach
Human Immunodeficiency Virus Infection Clinical Trial 2023: SIRI Checklist Highlights & Side Effects. Trial Name: NCT05480956 — N/A
SIRI Checklist 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480956 — N/A
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT05480956 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for the clinical trial currently?

"This clinical trial is still open for recruitment, as per the data hosted on clinicaltrials.gov. This study was put up on October 11th 2022 and has been recently updated November 3rd 2022."

Answered by AI

How many people have been recruited to participate in this experiment?

"Affirmative. Clinicaltrials.gov records verify that this medical study, which was first made public on October 11th 2022 is still actively recruiting participants. 60 volunteers are needed from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Up to trying anything.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
Ellen Eaton 2022. "SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05480956.
All > Opioid Dependence
~17 spots leftby Dec 2024
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