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Completed

NCT Number: NCT06489535

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

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

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Key information

Conditions

Opioid Use Disorder Abscess Arthritis Arthritis, Infectious Bloodstream Infection Bone Diseases Bone Diseases, Infectious Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Infections Chemically-Induced Disorders Endocarditis Epidural Abscess Heart Diseases Infections Inflammation Joint Diseases Mental Disorders Musculoskeletal Diseases Narcotic-Related Disorders Nervous System Diseases Opioid-Related Disorders Osteomyelitis Pathologic Processes Pathological Conditions, Signs and Symptoms Perimeningeal Infections Sepsis Septic Arthritis Substance-Related Disorders Suppuration Systemic Inflammatory Response Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RETAIN

Other

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).

Unrelated videos

Other

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)

Primary outcomes

  1. Number of days on medications for opioid disorder (MOUD)

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

    The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.

  2. Participant recruitment rates

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

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

  3. Feasibility of the RETAIN Intervention based on completion of study visits

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

    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.

  4. Acceptability of the RETAIN Intervention

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

    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.

Secondary outcomes

  1. Number of days of antibiotic completion

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

    Self-report yes or no.

  2. Number of days of Opioid use

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

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

  3. Number of Hospitalizations

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

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

  4. Number of uncleaned injections

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

    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.

  5. Number of unmonitored opioid use

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

    Self Report based on Opioid use

  6. MOUD stigma

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

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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: RETAIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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