ClinicalTrials.gg
CompletedNCT06489535RETAINUpdated Jul 2, 2026

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

An interventional study of RETAIN and Unrelated videos in Opioid Use Disorder, Bloodstream Infection and Osteomyelitis, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Opioid Use Disorder
  • Bloodstream Infection
  • Osteomyelitis
  • Endocarditis
  • Septic Arthritis
  • Epidural Abscess

Keywords

  • Recovery Management Checkups (RMC)
  • Serious injection related infections (SIRI)
  • Medications for OUD (MOUD)
  • Re-hospitalizations
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 40 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Between 18 and 65 years of age
  • Able to provide
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherRETAIN

    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).

  • OtherUnrelated 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  2. Participant recruitment rates

    Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  3. 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.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  4. 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.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

Secondary outcomes

  1. Number of days of antibiotic completion

    Self-report yes or no.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  2. Number of days of Opioid use

    The TLFB method will be used to assess this outcome based on self-report.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  3. Number of Hospitalizations

    The TLFB method will be used to assess this outcome based on self-report.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  4. 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.

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  5. Number of unmonitored opioid use

    Self Report based on Opioid use

    Time frame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge

  6. MOUD stigma

    Partial adaptation of MMT-SMS stigma scale will be used to assess this outcome based on self-report

    Time frame: Baseline while hospitalized, and 6 month after discharge

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in May 2026, 16 months.

Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 16 months is below that.

Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2024
First posted
Jul 8, 2024
StartActual
Jan 6, 2025
Primary completionActual
May 11, 2026
CompletionActual
May 11, 2026
Last update
Jul 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06489535
Responsible party
Sponsor
First posted
Jul 8, 2024
Start date
Jan 6, 2025
Primary completion
May 11, 2026
Completion
May 11, 2026
Last update
Jul 2, 2026

Study contacts

Simeon Kimmel, MD
principal investigator · Boston Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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