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Behavioural Intervention

RETAIN intervention for Bloodstream Infection (RETAIN Trial)

N/A
Waitlist Available
Led By Simeon Kimmel, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Between 18 and 65 years of age
* Able to provide Informed Consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Awards & highlights

Summary

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

Who is the study for?
The RETAIN trial is for individuals who have been hospitalized with serious injection-related infections (SIRI) like sepsis or endocarditis and also struggle with opioid use disorder. It's designed to help them stay on treatment after hospitalization.
What is being tested?
This pilot study tests an adapted intervention called Recovery Management Checkups (RMC), which aims to improve long-term treatment retention in patients recovering from SIRI and OUD. Participants will receive the RMC intervention, while its feasibility and preliminary efficacy are assessed.
What are the potential side effects?
Since this trial focuses on a behavioral intervention rather than medication, traditional side effects related to drugs are not applicable. However, participants may experience emotional discomfort discussing their addiction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the RETAIN Intervention
Feasibility of the RETAIN Intervention based on completion of study visits
Number of days on medications for opioid disorder (MOUD)
+1 more
Secondary study objectives
Number of Hospitalizations
Number of days of Opioid use
Number of days of antibiotic completion
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RETAIN interventionExperimental Treatment1 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.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
395 Previous Clinical Trials
875,712 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,532 Previous Clinical Trials
3,246,608 Total Patients Enrolled
Simeon Kimmel, MDPrincipal InvestigatorBoston Medical Center
~27 spots leftby Dec 2025