Peer Recovery Support in the Homeless Health Care Setting (SUPPORT)

November 6, 2026 updated by: Danielle, Fine, Massachusetts General Hospital

Studying the Use of Peers to Promote Opioid Recovery Treatment: A Pilot Trial

The goal of this clinical trial is to learn whether a peer recovery support program designed for people experiencing homelessness can be successfully delivered as part of opioid use disorder treatment. Peer recovery support specialists are individuals who use their personal experience with substance use and recovery to support others. The main questions this pilot study aims to answer are:

  • Is it feasible to conduct the study and deliver the peer recovery support program?
  • Is the program acceptable to participants?
  • Can the program be delivered as intended?
  • Does the program show promise for helping participants stay engaged in opioid use disorder treatment?

Researchers will compare participants who receive peer recovery support in addition to usual opioid use disorder treatment with participants who receive usual treatment alone.

Participants will:

  • Be randomly assigned to one of the two study groups.
  • Complete a survey when they enroll and another survey approximately 3 months later.
  • If assigned to the peer recovery support group, be offered individualized support from a peer recovery support specialist for 3 months, with meetings approximately weekly.
  • If assigned to the peer recovery support group, complete an interview at the end of the study about their experiences with the program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

### Study Rationale

Developing effective strategies to improve opioid use disorder (OUD) treatment retention among people experiencing homelessness (PEH) is important to reducing mortality in this high-risk population. Evidence from general OUD treatment settings suggests that peer recovery support services may improve treatment engagement and outcomes. Peer recovery support may be particularly beneficial for PEH, who often experience adverse social determinants of health, have limited social support, and face challenges navigating health care and social service systems.

The investigators developed a peer recovery support intervention tailored to the homeless health care setting, informed by patient focus groups, interviews with key informants from Health Care for the Homeless programs, and a community-engaged modified Delphi process.

### Study Objectives

The objective of this randomized pilot trial is to evaluate a 90-day peer recovery support intervention designed to improve OUD treatment retention among PEH. The primary objectives are to assess the feasibility of study procedures, intervention feasibility and acceptability, and intervention fidelity. Secondary objectives include exploring preliminary differences in OUD treatment retention and other clinical and psychosocial outcomes between study arms. Findings will inform intervention refinement and the design of a future, larger randomized controlled trial.

### Study Design and Setting

This study is a two-arm randomized pilot trial involving 40 adults with OUD initiating a new treatment episode at the Boston Health Care for the Homeless Program (BHCHP) office-based addiction treatment (OBAT) program at Jean Yawkey Place in Boston, Massachusetts.

Potential participants will be identified through collaboration with OBAT clinicians and staff and through electronic health record reports identifying patients initiating a new OBAT treatment episode. Interested individuals will undergo eligibility screening and informed consent within 7 days of their initial OBAT visit.

Following informed consent, participants will be randomized in a 1:1 ratio to receive either usual OBAT care (n=20) or peer recovery support in addition to usual OBAT care (n=20). Randomization will be conducted using REDCap. Study assignment will be concealed from participants until completion of the baseline survey.

### Study Procedures

Participants in both study arms will complete a baseline survey and a 90-day follow-up survey. Surveys will assess substance use, mental health, social support, and other factors potentially associated with OUD treatment engagement.

Following completion of the baseline survey, participants will be informed of their study assignment. Participants randomized to the intervention arm will be introduced to the peer recovery support specialist through a warm handoff whenever feasible. When an in-person introduction is not possible, the peer recovery support specialist will initiate outreach following enrollment.

Participants randomized to the usual care arm will continue to receive standard OBAT care without the addition of study-provided peer recovery support services.

### Peer Recovery Support Intervention

Participants randomized to the intervention arm will be offered 90 days of individualized support from a peer recovery support specialist in addition to usual OBAT care. The intervention is grounded in principles of harm reduction and patient-centered care, with an emphasis on developing trusting relationships and addressing barriers to OUD treatment engagement.

During the intervention period, the peer recovery support specialist will aim to meet with participants approximately weekly. The frequency, timing, duration, and content of sessions will be tailored to participants' needs, preferences, and availability. Additional contacts or meetings may occur as needed. Sessions may take place in person, by telephone, or by videoconference, with in-person meetings encouraged when feasible. Text messaging may also be used for communication and coordination with participants who provide consent.

Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and connections to treatment and community resources. The specific support provided will be individualized based on each participant's needs and goals.

Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist.

Throughout the intervention period, the peer recovery support specialist will meet approximately weekly with an experienced supervisor to review intervention delivery, participant engagement, peer support boundaries, and challenging situations. Additional supervision will be available as needed.

The peer recovery support specialist will document all participant contacts and outreach attempts using standardized forms in REDCap. Documentation will include the frequency, duration, and mode of contact, as well as intervention components delivered. These data will be used to assess intervention delivery and fidelity.

At the conclusion of the 90-day intervention period, the peer recovery support specialist will work with participants, as appropriate, to identify ongoing sources of peer, clinical, or community support.

### Follow-up and Data Collection

Participants in both study arms will be invited to complete a follow-up survey between 90 and 105 days after randomization. Follow-up assessments may be completed in person or by telephone.

Participants randomized to the intervention arm will also be invited to complete a qualitative exit interview lasting approximately 45-60 minutes. Interviews will explore participants' experiences with the intervention, including its acceptability, perceived benefits, fit with participants' needs, and implementation. Interviews will be audio-recorded for qualitative analysis.

Electronic health record data will also be collected to assess OUD treatment engagement and retention during the study period. These data, together with participant surveys, intervention documentation, and qualitative interviews, will be used to evaluate the pilot trial objectives.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged at least 18 years
  • Proficient in English
  • Diagnosis of opioid use disorder, assessed by the clinical provider and documented within the patient's EHR
  • New OBAT treatment episode, defined as having had no clinical encounters in the OBAT program during the prior 60 days

Exclusion Criteria:

  • Inability to demonstrate adequate understanding of the informed consent information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual OBAT Care

Participants in this arm will receive usual OBAT care
Experimental: Peer support

Participants in this arm will receive usual OBAT care and additional support from a peer recovery support specialist
Behavioral: Peer support

Participants assigned to the intervention arm will be offered 90 days of individualized peer recovery support in addition to usual office-based addiction treatment (OBAT) care.

The peer recovery support specialist will aim to meet with participants approximately weekly over the intervention period. The frequency, duration, timing, and content of meetings will be tailored to participants' needs and preferences, with additional contacts available as needed. Meetings may take place in person, by telephone, or by videoconference.

Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and linkage to treatment and community resources. Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: During recruitment period

Proportion of eligible individuals who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible individuals screened.
During recruitment period
Randomization rate
Time Frame: At enrollment

Proportion of enrolled participants who are successfully randomized to a study arm, calculated as the number of randomized participants divided by the total number enrolled.
At enrollment
Study retention rate
Time Frame: 90-day follow-up (days 90-105 after randomization).

Proportion of randomized participants who complete the 90-day follow-up survey, calculated as the number completing the follow-up survey divided by the total number randomized.
90-day follow-up (days 90-105 after randomization).
Client Satisfaction Questionnaire Score
Time Frame: 90-day follow-up (days 90-105 after randomization)

Intervention acceptability will be assessed among participants randomized to the peer recovery support intervention using the 8-item Client Satisfaction Questionnaire (CSQ-8). Scores range from 8 to 32, with higher scores indicating greater satisfaction with services received.
90-day follow-up (days 90-105 after randomization)
Number of Completed Peer Support Sessions
Time Frame: Randomization through day 90

Total number of completed peer support sessions per intervention participant during the 90-day period.
Randomization through day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Retention in Office-Based Addiction Treatment (OBAT) at 90 Days
Time Frame: Days 75-105 following enrollment

Proportion of participants with at least one completed in-person or virtual OBAT clinical encounter between days 75 and 105 following the baseline visit, assessed using electronic health record data.
Days 75-105 following enrollment
Self-Reported Buprenorphine Adherence
Time Frame: Past 30 days at the 90-day follow-up

Number of days covered by buprenorphine during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating greater medication coverage.
Past 30 days at the 90-day follow-up
Buprenorphine Percent of Days Covered
Time Frame: Enrollment through day 90

Percentage of days covered by buprenorphine during the 90-day study period, calculated using electronic health record medication data. Values range from 0% to 100%, with higher values indicating greater medication coverage.
Enrollment through day 90
Past 30-Day Non-Prescribed Opioid Use
Time Frame: Past 30 days at the 90-day follow-up.

Number of days of non-prescribed opioid use during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating more frequent opioid use.
Past 30 days at the 90-day follow-up.
Change in Opioid Use Severity
Time Frame: Baseline and 90-day follow-up

Change in opioid use severity from baseline to the 90-day follow-up, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-based opioid use severity score. Higher scores indicate greater opioid use severity.
Baseline and 90-day follow-up
Change in Recovery
Time Frame: Baseline and 90-day follow-up

Change in recovery from baseline to the 90-day follow-up, assessed using the Substance Use Recovery Evaluator (SURE) total score. Higher scores indicate greater recovery.
Baseline and 90-day follow-up
Change in Emotional Support
Time Frame: Baseline and 90-day follow-up

Change in perceived emotional support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Emotional Support Short Form. Higher scores indicate greater perceived emotional support.
Baseline and 90-day follow-up
Change in Instrumental Support
Time Frame: Baseline and 90-day follow-up

Change in perceived instrumental support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Instrumental Support Short Form. Higher scores indicate greater perceived instrumental support.
Baseline and 90-day follow-up
Change in Informational Support
Time Frame: Baseline and 90-day follow-up

hange in perceived informational support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Informational Support Short Form. Higher scores indicate greater perceived informational support.
Baseline and 90-day follow-up
Change in Companionship
Time Frame: Baseline and 90-day follow-up

Change in perceived companionship from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Companionship Short Form. Higher scores indicate greater perceived companionship.
Baseline and 90-day follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Peer Support Sessions
Time Frame: Randomization through day 90

Duration in minutes of completed peer support sessions, summarized across intervention participants.
Randomization through day 90
Delivery of Intervention Components
Time Frame: Randomization through day 90

Frequency with which prespecified peer support intervention components are documented as delivered, based on the Peer Support Contact and Fidelity Log.
Randomization through day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026P003043
  • K23DA058200 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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