Project STAMINA (Syringe Service Treatment Access for Medication-assisted Intervention Through NAvigation) (STAMINA)

• ClinicalTrials.gov Identifier: NCT04575324
• Recruitment Status: Recruiting
• First Posted: October 5, 2020
• Last Update Posted: February 15, 2022
• Sponsor: Chestnut Health Systems
• Collaborator: University of Illinois at Chicago
• Information provided by (Responsible Party): Chestnut Health Systems

Study Description

Brief Summary:

Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine approach for linking syringe exchange clients to medications for opioid use disorder. This pilot study aims to recruit n=273 people and utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage and (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. The study will utilize qualitative and quantitative data, including questionnaire data, drug test results, and administrative treatment data, at multiple time points to determine what effect telemedicine linkage has on clients in relation to the comparison group.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder	Behavioral: Telemedicine Linkage Intervention	Not Applicable

Detailed Description:

INTERVENTION DESCRIPTION:

Project STAMINA utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. All enrollment and telemedicine care will occur at one of three Chicago-based and university-affiliated syringe service program (SSP) sites, where the primary purpose is providing free access to syringes for people who inject drugs.

Intervention Arm (1): Participants enrolled into the telemedicine linkage intervention will be immediately linked to telemedicine care provided by a university-affiliated federally qualified health center (FQHC) that can prescribe buprenorphine and naltrexone and has a relationship with a methadone treatment provider they can refer patients to as appropriate. Study participants prescribed buprenorphine or naltrexone will be able to receive MOUD treatment at any of the 6 FQHC locations across the city, three of which are in relatively close proximity to the SSP sites, and a no-cost induction buprenorphine prescription can be dispensed from their main office. The FQHC can also refer to a methadone provider with various locations throughout the city. At the SSP, the participant will have their vitals checked by a research team member and be connected with the FQHC provider via an iPad. The research assistant will share the participant's vitals with the provider, and the provider will complete a virtual treatment appointment. The research assistant will offer the participant transportation assistance to pick up the first buprenorphine or naltrexone prescriptions or to attend the first methadone referral appointment. Transportation to pick up the prescription will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip. Further, to support the intervention, the research assistant will also provide a visual guide at enrollment (i.e. picture directions) that describes how to navigate the FQHC pharmacy, as well as a scheduling card that allows them to record any MOUD appointment dates. All follow-up OUD care and prescribing will be conducted based on the provider's standards and may include in-person or telemedicine appointments. Should the provider deem an in-person intake appointment clinically necessary for any participant assigned to the treatment arm, the research assistant will provide a full-day bus pass to assist with transportation.

Standard Care Arm (2): Participants enrolled in the control arm will receive a standard referral to an in-person appointment, also with a provider from the same FQHC sites. This appointment will involve an in-person meeting with the provider, which will occur within 24-72 hours of the enrollment time. After study enrollment, the research assistant will utilize the FQHC electronic scheduling system to schedule this in-person appointment. The research assistant will also provide the participant with an appointment reminder card for this appointment and a full-day bus pass to cover the transportation to and from the appointment, which aligns with standard care at the SSP. All follow-up OUD care and prescribing will be conducted based on the provider's standards and may include in-person or telemedicine appointments.

RESEARCH DESIGN:

Participants will be identified one of the following ways: (1) individuals will see the STAMINA poster within the syringe exchange site and be able to ask staff where to get more information, (2) individuals will inform syringe service staff that they are interested in treatment for an opioid use disorder, and staff will inform them of the study opportunity, (3) individuals will see a STAMINA flyer at another social service program in the city and be able to call study personnel for more information on the study and how to get to syringe exchange, (4) individuals will see marketing material distributed via social media platforms by the TrialFacts company, contact the TrialFacts company, and then be put in touch with a STAMINA research assistant, or (5) individuals will be introduced to the study by street outreach staff.

Research personnel will be responsible for assessing SSP clients for eligibility. Using the recruitment script, after providing an introduction to STAMINA and a reason for the eligibility questions, the research assistant will begin to read the full script, which includes an assessment of eligibility criteria. Any client who is eligible and interested in participating will move forward with the statement of informed consent. Willing participants will be asked to sign the consent form.

Once the participant has been officially enrolled, the research assistant will privately open the arm assignment card, which will contain the pre-established random arm assignment and be stored in closed envelope within the enrollment packet. Each arm assignment card will include two stratified randomization blocks: (1) one arm assignment will be for participants who are interested in receiving buprenorphine or naltrexone, or open to considering these types, [Open MOUD Stratified Arm Assignment] (2) one arm assignment will be for participants who are only interested in receiving methadone [Methadone Only Stratified Arm Assignment]. Based on the participant's interest in MOUD, which will have been clarified during the eligibility assessment, the research assistant will read the appropriate random arm assignment. If the participant is assigned to the telemedicine intervention arm, the research assistant will need to notify the FQHC of an upcoming virtual appointment [the FQHC needs a one-hour notice of appointment]. At this time, they will not yet inform the participant of their arm assignment so that baseline data collection can be completed prior to notification.

The first step in data collection will be to complete a questionnaire. The research assistant will first notify another off-site research assistant that the participant is ready to complete data collection. The off-site research assistant will connect with the participant via video to collect the questionnaire data; this allows for blinded data collection, as the off-site research assistant will not know the arm assignment. The questionnaire will take approximately 45-60 minutes and be administered by research staff using the Research Electronic Data Capture (REDCap) data collection system, which is a secure, HIPAA-compliant, web-based survey instrument. The questionnaire will be administered in a standard manner, meaning: (1) all questions will be asked, (2) all questions will be read as written, (3) research assistants will not reword questions in any way, and (4) participants have the right to refuse to answer any question.

This questionnaire will cover the following topics:

• Full name, Date of Birth, SSN, and UI Health Medical Record Number (MRN)
• Demographic information
• Social support
• Child welfare involvement
• Housing and homelessness
• Alcohol use
• Drug use
• Heroin cravings
• Opioid withdrawal symptoms
• Overdose experiences
• Physical and mental health
• Trauma exposure
• Criminal justice involvement
• Treatment motivation
• Quality of life

The questionnaire will also request participant contact information. This information will not be used as research data, but rather, will aid the scheduling of research follow-up visits. The form will ask participants for (1) their contact information, (2) the contact information for others who might be able to help in reaching the participant, (3) the contact information for providers whose services they utilize and might be able to help reach the participant. The participants are reminded at the beginning of the form that they have the right to refuse any question and only share what they want to share. Because of the transient nature of the participant population, additional contacts are helpful in reaching the participant should personal contact information change.

Participants will be asked to complete the REDCap questionnaire at baseline and 3 months after baseline. Each questionnaire will take 45-60 minutes to complete. All questionnaires (baseline & 3-months) will be completed at the SSP by a research team member. Though the first questionnaire will be completed over video, the follow-up questionnaire will be completed over telephone. Participants will be asked to return to the SSP, despite doing the interview with via telephone because they will be asked to also complete a drug screen at follow-up (described below).

Immediately following the questionnaire, all participants will be asked to submit a urine drug screen, as a form of data collection. The drug screen will be completed on-site, immediately following the REDCap questionnaire. The drug screen takes 1-2 minutes to complete. This will also be completed at baseline and 3-months.

Once participants have completed all baseline data collection, they will be notified of their random study arm assignment. At this time, participants randomized to the telemedicine intervention arm would be connected via telemedicine to the FQHC provider and take part in the intervention described above. Participants randomized to the control arm would receive a scheduled in-person appointment at a FQHC location.

At the end of the visit with the research staff, all participants will receive materials that aid follow-up data collection and prepare them for the data collection timeline. All participants will be given a scheduling form that visually displays the data collection items in the order of their occurrence. Participants will be offered a paper copy or invited to take a picture of the schedule to store on their phone, if applicable. Participants will also be provided with the STAMINA contact telephone number and asked to store it in their phone, if applicable. They will be shown the STAMINA website and QR code.

SECONDARY DATA COLLECTION:

As a part of the consent and health information release process, we request to access participant protected health information (PHI) from the four sources listed below.

(1) FQHC and (2) methadone provider We will request that the FQHC and methadone provider pull treatment data, including dates of service, medications prescribed, and treatment details to understand compliance.

(3) State Prescription Monitoring Program (PMP) records We will request the state prescription monitoring program (PMP) data for the purpose of verifying the information provided by the participant during the REDCap questionnaire. While we ask the participant to self-report whether they have engaged in medication for opioid use disorder treatment, the PMP data will allow us to verify whether they have been prescribed/dispensed any of the prescriptions or prescriptions not mentioned during the interview.

(4) State Vital Records Similarly, we request state vital records data for the purpose of verifying whether a participant passed away. We are obtaining this data to verify if a participant disengaged from the study because of death and to understand whether that death was caused by drug use.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Project STAMINA (Syringe Service Treatment Access for Medication-assisted Intervention Through NAvigation): Development and Testing of a Health Navigation Approach for Linking Syringe Service Program Clients to Medication Assisted Treatment
• Actual Study Start Date: August 24, 2020
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Arm; Participants will receive the telemedicine linkage intervention.	Behavioral: Telemedicine Linkage Intervention; Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
No Intervention: Control Arm; Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.

Outcome Measures

Primary Outcome Measures :

1. Linkage to medication for opioid use disorder (MOUD) [ Time Frame: Within 14 days of enrollment ]
   Whether the participant attends 1 MOUD treatment appointment

Secondary Outcome Measures :

1. Medication for opioid use disorder (MOUD) treatment engagement [ Time Frame: Within 34 days of enrollment ]
   Whether the participant attends 2 treatment appointments
2. Medication for opioid use disorder (MOUD) treatment retention [ Time Frame: 6 month study period ]
   Whether the participant is actively engaged in treatment (i.e. participant goes no more than 14 days without medication for opioid use disorder (MOUD) or being discharged from care)
3. Self-report non-medication for opioid use disorder (MOUD) use [ Time Frame: 6 month study period ]
   Self reported days of non-prescribed opioid use in the past 30 days using questions from the National Survey on Drug Use and Health, which was modified to ask about separate known use of heroin, fentanyl/carfentanyl, and prescription pain killers
4. Detected non-prescribed opioids [ Time Frame: 6 month study period ]
   Detected illicit opioids through saliva test administered at baseline, 3 months, and 6 months

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• communicate in English
• be at least 18 years of age
• reside in Cook County, Illinois
• score at least "2" on the Opioid Use Disorder Screening tool (DSM), indicating mild opioid use disorder
• express interest in receiving medication for an opioid use disorder (MOUD)

Exclusion Criteria:

• have plans to move outside of Cook County, Illinois within the next 6 months
• have plans to serve a sentence that requires reporting to jail or prison within the next 6 months
• score "36" or higher on the Clinical Opioid Withdrawal Scale (COWS), indicating severe opioid withdrawal symptoms
• currently taking any form of medication that has been prescribed by a healthcare provider to treat opioid use disorder
• demonstrate inadequate ability to provide informed consent, as indicated by poor understanding of research based on 3 competency questions asked related to study.

Contacts and Locations

Contacts

Contact: Dennis P Watson, PhD; 312-274-5316; dpwatson@chestnut.org

Contact: Lisa D Robison Taylor, MPH; 812-521-2588; ldrobiso@uic.edu

Locations

United States, Illinois

University of Illinois at Chicago Community Outreach Intervention Projects (COIP) Field Site; Recruiting

Chicago, Illinois, United States, 60647

Contact: Antonio D Jimenez, PhD 312-413-1663 adj@uic.edu

Sponsors and Collaborators

Chestnut Health Systems

University of Illinois at Chicago

Investigators

• Principal Investigator: Dennis P Watson, PhD; Chestnut Health Systems
• Principal Investigator: James A Swartz, PhD; University of Illinois at Chicago

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Watson DP, Swartz JA, Robison-Taylor L, Mackesy-Amiti ME, Erwin K, Gastala N, Jimenez AD, Staton MD, Messmer S. Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial. BMC Public Health. 2021 Mar 31;21(1):630. doi: 10.1186/s12889-021-10669-0.

• Responsible Party: Chestnut Health Systems
• ClinicalTrials.gov Identifier: NCT04575324
• Other Study ID Numbers: 1138-0420
• First Posted: October 5, 2020
• Last Update Posted: February 15, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chestnut Health Systems:

Opioid Use Disorder; Injection Drug Use; Telemedicine; Telehealth; Syringe Exchange; Medication for Opioid Use Disorder; Medication Assisted Treatment; Substance Use Disorder; Syringe Service Program; Needle Exchange

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders