Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN) (RETAIN)

Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study

This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.

Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.

The study objectives are to:

• Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
• Establish preliminary estimates of intervention efficacy.
• Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.

Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder; Endocarditis; Osteomyelitis; Bloodstream Infection; Septic Arthritis; Epidural Abscess
• Intervention / Treatment: Other: RETAIN; Other: Unrelated videos

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between 18 and 65 years of age
• Able to provide Informed Consent
• Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended

Exclusion Criteria:

• Not able to give informed consent
• Cognitive ability (defined through Research Assistant (RA) determination)
• Inability to complete assessments in English or Spanish (defined through RA determination).
• Exclusion for any reason under PI discretion
• Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
• In police custody or expecting incarceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RETAIN intervention; Participants randomized to the RETAIN intervention will receive Motivational Interviewing targeted to their clinical concerns and personalized support tailored to each participants' specific needs determined by their answers to intake questions.	Other: RETAIN; There are 6 different modules that a participant in the RETAIN intervention group can be placed in: "Reinforce Antibiotic Completion", "Linkage to Antibiotic Treatment/Alternate Plan", "Reinforce Recovery", "Linkage to MOUD/Alternate Plan", "Reinforce Treatment Attendance", and "Harm Reduction Support". Participants may be assigned to no more than three modules at a time until they finish their antibiotics. After the completion of antibiotics, participants may only be in two modules. Participants' intervention can range from 15 minutes- 60 minutes depending on what modules they are placed in and how much support they feel they need. Interventions will begin at the two-week follow up after a participant has been discharged from Boston Medical Center (BMC).
Active Comparator: Control; Control arm participants will be offered different videos or podcast episodes that are unrelated to the study topics of infections, substance use, overdose, and medication management.	Other: Unrelated videos; These videos unrelated to the study topics will last approximately 30-45 minutes. Depending on the method of communication, participants will watch a video (in person) or listen to a podcast (remote)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days on medications for opioid disorder (MOUD)	The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Participant recruitment rates	Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Feasibility of the RETAIN Intervention based on completion of study visits	The rates of completion of study visits will be calculated by dividing the number of completed study visits by the total number of study visits.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Acceptability of the RETAIN Intervention	Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean and higher scores are associated with better acceptability.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of antibiotic completion	Self-report yes or no.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of days of Opioid use	The TLFB method will be used to assess this outcome based on self-report.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of Hospitalizations	The TLFB method will be used to assess this outcome based on self-report.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of uncleaned injections	Self Report based on the The Bacterial Skin Index Risk Score (BIRSI) score, which includes questions about alcohol pad and sterile water use, handwashing, rotating injection sites, injecting subcutaneously or in the muscle ("skin/muscle popping"), and clean needle use, was used as a continuous score to measure risk of skin and soft tissue infections.	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Number of unmonitored opioid use	Self Report based on Opioid use	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
MOUD stigma	Partial adaptation of MMT-SMS stigma scale will be used to assess this outcome based on self-report	Baseline while hospitalized, and 6 month after discharge

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Simeon Kimmel, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): May 11, 2026
• Study Completion (Actual): May 11, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Recovery Management Checkups (RMC); Serious injection related infections (SIRI); Medications for OUD (MOUD); Re-hospitalizations
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Heart Diseases; Arthritis; Joint Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bone Diseases, Infectious; Substance-Related Disorders; Chemically-Induced Disorders; Suppuration; Central Nervous System Infections; Abscess; Perimeningeal Infections; Pathological Conditions, Signs and Symptoms; Opioid-Related Disorders; Sepsis; Endocarditis; Arthritis, Infectious; Osteomyelitis; Epidural Abscess
• Other Study ID Numbers: H-44905; K23DA054363 (U.S. NIH Grant/Contract)

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