STRIVES: Status-Neutral TeleHealth Concierge Intervention for Unhoused People Who Use Drugs Via Engagement Through Street Medicine

This study is testing a novel telehealth-based, status-neutral care model for integrating HIV prevention/treatment and substance use disorder services into street-based primary care for people experiencing homelessness who use drugs.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Homelessness; HEPATITIS C (HCV); Substance Use Disorder (SUD)
• Intervention / Treatment: Behavioral: Standard of Care (Patient Navigation to Off-Site Clinic); Behavioral: Status-Neutral Telehealth Concierge (SN-THR)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyler S Bartholomew, PhD; Phone Number: 305-243-4625; Email: tsb61@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 or older
• Able to speak English or Spanish
• Willing and able to sign informed consent, provide locator information, and complete medical records release
• Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current alcohol or substance use disorder
• Meets study-defined criteria for homelessness or housing instability by self-report
• Interested in initiating or continuing Antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP), as applicable based on HIV status
• Planning to stay in the area for 12 months

Exclusion Criteria:

• Investigator discretion
• Currently in prison or jail
• Does not meet DSM-5 criteria for current alcohol or substance use disorder
• Does not meet study-defined criteria for homelessness or housing instability by self-report
• Not interested in initiating or continuing ART or PrEP, as applicable based on HIV status
• Current enrollment in PROTECT or CHARIOT
• Planning to leave the area within 12 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Group (Off-site clinic referral and patient navigation); Participants in this arm receive standard patient navigation and referral services for healthcare and social support needs for one year.	Behavioral: Standard of Care (Patient Navigation to Off-Site Clinic); Participants receive standard patient navigation and referral services, including linkage to community healthcare and social services, transportation assistance, case management, wound care, and referrals for HIV care, pre-exposure prophylaxis (PrEP), substance use treatment, mental health services, and primary care
Experimental: Status-Neutral Telehealth Concierge (SN-THR) Group; Participants in this arm receive the SN-THR intervention, a multidisciplinary street medicine and telehealth program providing integrated medical care, behavioral health services, care coordination, and social support for one year.	Behavioral: Status-Neutral Telehealth Concierge (SN-THR); SN-THR is a multidisciplinary street medicine and telehealth intervention that provides medical care, behavioral health services, peer support, care coordination, street-based laboratory services, and social services. Participants receive telehealth technology, motivational interviewing, medication support, and assistance addressing housing, food insecurity, and insurance barriers during the 12-month intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral Adherence for Treatment/Prevention	Proportion of participants adherent to Antiretroviral Therapy (ART) for HIV treatment/prevention. HIV treatment adherence (ART adherence) will be defined by HIV RNA level <200 copies/mL for PWH. PrEP adherence will be defined by any of the following: Dried Blood Spot (DBS) tenofovir diphosphate (TFV-DP) level of 700 fmol/punch for tenofovir disoproxil fumarate (TDF); DBS TFV-DP level of 950 fmol/punch for tenofovir alafenamide (TAF); or documentation of long-acting ART/PrEP (cabotegravir injection in the previous 8 weeks or lenacapavir injection in the previous 6 months) via EHR abstraction.	Baseline, 3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in Substance Use Disorder (SUD) Treatment	Engagement in Substance Use Disorder (SUD) treatment will be assessed as the proportion of participants who engage in treatment services. Engagement will be defined by any of the following: Documentation in the electronic health record (EHR) of an evaluation for medications for opioid use disorder (MOUD) or prescription of psychotropic medications for other substance use disorders; Attendance at individual psychotherapy or group psychotherapy sessions documented in the EHR; or self-reported attendance at Narcotics Anonymous (NA) or Alcoholics Anonymous (AA) meetings.	Baseline, 3, 6, 9, and 12 months
Receipt of Primary Care by U.S. Preventive Services Task Force (USPSTF) Recommended Services	Primary care preventive services will be assessed as the total number of applicable U.S. Preventive Services Task Force (USPSTF)-recommended preventive services received based on participant characteristics, as determined by electronic health record (EHR) abstraction. Preventive services may include, but are not limited to, cervical cancer screening, colorectal cancer screening, breast cancer screening, lung cancer screening, abdominal aortic aneurysm screening, hypertension screening, diabetes screening, and age- and risk-appropriate USPSTF-recommended vaccinations.	Baseline, 3, 6, 9, and 12 months
Non-fatal overdose	Non-fatal overdose will be assessed as the number of self-reported count of non-fatal overdose experiences.	Baseline, 3, 6, 9, and 12 months
Possession of Naloxone	Possession of Naloxone will be assessed as the proportion of participants having naloxone on person at the time of assessment. Documented naloxone possession via photo.	Baseline, 3, 6, 9, and 12 months
Medications for Opioid Use Disorder (MOUD) Adherence	Medications for opioid use disorder (MOUD) adherence will be assessed as the proportion of participants using MOUD. Adherence is defined as detection of buprenorphine or methadone on point-of-care urine drug screening (UDS) or documentation of extended-release naltrexone or extended-release buprenorphine injection administration within the previous 4 weeks, as determined by electronic health record (EHR) abstraction.	Baseline, 3, 6, 9, and 12 months
Hepatitis C virus (HCV) cure: Sustained Virologic Response	Hepatitis C virus (HCV) cure will be assessed as the proportion of participants with a positive hepatitis C virus ribonucleic acid (HCV RNA) result at baseline who receive direct-acting antiviral (DAA) therapy and achieve a negative hepatitis C virus ribonucleic acid polymerase chain reaction (HCV RNA PCR) result at least 4 weeks after treatment completion collected with blood samples.	Baseline, 3, 6, 9, and 12 months
Treatment of Sexually Transmitted Infections (STIs)	Treatment of sexually transmitted infections (STIs) will be assessed as the number of STI infections that resolve during the 12- month follow-up period. Resolution is defined as a negative gonorrhea or chlamydia test following a prior positive test or a fourfold reduction in syphilis titers at least 6 months after a positive test.	Baseline, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tyler S Bartholomew, PhD, University of Miami; Principal Investigator: Hansel E Tookes, MD, MPH, University of Miami; Principal Investigator: Armen Henderson, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: November 5, 2026
• First Submitted That Met QC Criteria: November 5, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Mental Disorders; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Chemically-Induced Disorders; Flaviviridae Infections; Hepatitis; Substance-Related Disorders; Hepatitis C; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 20251386; R01DA065187 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No