Opioid Use DisorderBRIDGE-SCNCT07541417
Building Retention and Initiation Through Delivery of Peer-Guided Evidence-Based Practices
A study testing Certified Peer Support Specialist Intervention in people with Opioid Use Disorder, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Certified Peer Support Specialist Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Have diagnosis of OUD
- New mobile health MOUD patient
Who cannot join
- Unable to read and comprehend the consent materials and other study materials
- Currently working with a Certified Peer Support Specialist
- Having severe medical or psychiatric disability that would hinder participation in the study, as determined by the clinical provider
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marisol Miranda contact
United States1 site, 1 recruiting
- Recruiting
Prisma Health Upstate
Greenville, South Carolina, 29605
Ashley King, MSW, (704) 936-9402, ashley.king3@prismahealth.org
Alain Litwin, MD, MPH, (864) 430-0911, alain.litwin@prismahealth.org
About this study
Official title: Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities Via Mobile Health Clinics and Peer Support Services
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.
Read the detailed description
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention.
The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.
- Conditions
- Opioid Use Disorder
- Being tested
- Certified Peer Support Specialist Intervention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certified Peer Support Specialist InterventionBehavioural
Participants are recruited from mobile health clinics (MHC) delivered to communities using a predictive modeling framework to target areas for optimal MHC allocation to maximize prevention of overdose deaths. Patients randomized to the intervention arm are linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support based on a peer support checklist. Peer support specialists will maintain contact and provide support for the participant for 6 months post-baseline, following a peer support manual.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The control condition involves the standard mobile recovery program (MRP) protocol. The MRP MOUD-specific capabilities are providing screening and assessments; induction monitoring; maintenance buprenorphine treatment; and follow-up care. The MRP is a facilitator of MOUD induction through partnerships with 340B pharmacies. Participants in both the standard of care condition and CPSS condition will receive MRP services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provision of take-home naloxone, fentanyl and/or xylazine test strips as needed. |
| Certified Peer Intervention Specialist | Experimental | The intervention includes standard of care described above and also involves a participant meeting with a certified peer support specialist (CPSS) throughout MOUD initiation and early maintenance phases (up to 24 weeks post-initiation). CPSS encounters may be in-person or virtual. CPSS will track their services provided throughout the study period utilizing the newly developed checklist, incorporated into REDCap. Receives: Behavioral: Certified Peer Support Specialist Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medications for Opioid Use Disorder (MOUD) Initiation
MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.
Measured: 3 months
Medications for Opioid Use Disorder (MOUD) Retention
MOUD retention at 6 months defined as receipt of 80% of MOUD prescriptions in first 6 months since baseline assessment.
Measured: 6 months
Secondary outcomes (13)
Adherence to Buprenorphine
Medication Adherence Self-Report Inventory (MASRI)
Measured: Weekly; 24 weeks
Barriers to Healthcare
Social Determinations of Health (SDOH)
Measured: 90 days
Frequency of Opioid Use
Addiction Severity Index (ASI-Lite) 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Measured: Monthly; 24 weeks
Overdose
Questionnaire
Measured: Weekly; 24 weeks
Hospitalizations/Emergency Department Visits
Questionnaire
Measured: Weekly; 24 weeks
Engagement in other Recovery Support Services
Questionnaire
Measured: Weekly; 24 weeks
Naloxone/Narcan Administration
Questionnaire
Measured: Weekly; 24 weeks
Fentanyl Test Strip Use
Questionnaire
Measured: Weekly; 24 weeks
Recovery Capital
Brief Assessment of Recovery Capital (BARC-10) Total scores can range from a minimum of 10 to a maximum of 60m, with a higher score indicating higher recovery capital.
Measured: 90 days
Social Support
Medical Outcome Study (MOS) n the original publication (Sherbourne and Stewart, 1991), scores were transformed to have a possible range of 0-100, with higher scores indicating more support. This transformation was the method used for all of the Medical Outcomes Study measures of functioning and well-being.
Measured: 90 days
Depression symptoms
Patient Health Questionnaire (PHQ-9) Scores can range from 0-27. 0-4 indicates no-minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-27 indicates severe depression.
Measured: 90 days
Anxiety symptoms
Generalized Anxiety Disorder (GAD-7) The GAD-7 is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and assess severity over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity
Measured: 90 days
Post-Traumatic Stress Disorder (PTSD) symptoms
PTSD Checklist (PCL-5) The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, with items rated from 0 ("Not at all") to 4 ("Extremely"). Total scores range from 0 to 80, with a score of 31-33 or higher typically indicating probable PTSD.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start8 Apr 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541417
- Sponsor's protocol ID
- 2399199
- Acronym
- BRIDGE-SC
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities Via Mobile Health Clinics and Peer Support Services
- ClinicalTrials.gov ID
- NCT07541417
- Acronym / sponsor ID
- BRIDGE-SC / 2399199
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.
Detailed description
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention.
The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The control condition involves the standard mobile recovery program (MRP) protocol. The MRP MOUD-specific capabilities are providing screening and assessments; induction monitoring; maintenance buprenorphine treatment; and follow-up care. The MRP is a facilitator of MOUD induction through partnerships with 340B pharmacies. Participants in both the standard of care condition and CPSS condition will receive MRP services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provision of take-home naloxone, fentanyl and/or xylazine test strips as needed. |
| Certified Peer Intervention Specialist | Experimental | Behavioral: Certified Peer Support Specialist InterventionThe intervention includes standard of care described above and also involves a participant meeting with a certified peer support specialist (CPSS) throughout MOUD initiation and early maintenance phases (up to 24 weeks post-initiation). CPSS encounters may be in-person or virtual. CPSS will track their services provided throughout the study period utilizing the newly developed checklist, incorporated into REDCap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Have diagnosis of OUD
- New mobile health MOUD patient
Key exclusion criteria (3 listed)
- Unable to read and comprehend the consent materials and other study materials
- Currently working with a Certified Peer Support Specialist
- Having severe medical or psychiatric disability that would hinder participation in the study, as determined by the clinical provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certified Peer Support Specialist InterventionParticipants are recruited from mobile health clinics (MHC) delivered to communities using a predictive modeling framework to target areas for optimal MHC allocation to maximize prevention of overdose deaths. Patients randomized to the intervention arm are linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support based on a peer support checklist. Peer support specialists will maintain contact and provide support for the participant for 6 months post-baseline, following a peer support manual. | Behavioural | Certified Peer Intervention Specialist |
Primary outcome
Medications for Opioid Use Disorder (MOUD) Initiation
Time frame: 3 months
MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.
Medications for Opioid Use Disorder (MOUD) Retention
Time frame: 6 months
MOUD retention at 6 months defined as receipt of 80% of MOUD prescriptions in first 6 months since baseline assessment.
13 secondary outcomes
Adherence to Buprenorphine
Time frame: Weekly; 24 weeks
Barriers to Healthcare
Time frame: 90 days
Frequency of Opioid Use
Time frame: Monthly; 24 weeks
Overdose
Time frame: Weekly; 24 weeks
Hospitalizations/Emergency Department Visits
Time frame: Weekly; 24 weeks
Engagement in other Recovery Support Services
Time frame: Weekly; 24 weeks
Naloxone/Narcan Administration
Time frame: Weekly; 24 weeks
Fentanyl Test Strip Use
Time frame: Weekly; 24 weeks
Recovery Capital
Time frame: 90 days
Social Support
Time frame: 90 days
Depression symptoms
Time frame: 90 days
Anxiety symptoms
Time frame: 90 days
Post-Traumatic Stress Disorder (PTSD) symptoms
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marisol Miranda contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certified Peer Support Specialist Intervention in people with Opioid Use Disorder, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley King, MSW (7049369402, ashley.king3@prismahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medications for Opioid Use Disorder (MOUD) Initiation (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.