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

5 de noviembre de 2026 actualizado por: Tyler Scott Bartholomew, University of Miami

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Tyler S Bartholomew, PhD
  • Número de teléfono: 305-243-4625
  • Correo electrónico: tsb61@miami.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

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.

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Antiretroviral Adherence for Treatment/Prevention
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Engagement in Substance Use Disorder (SUD) Treatment
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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)
Periodo de tiempo: Baseline, 3, 6, 9, and 12 months

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Tyler S Bartholomew, PhD, University of Miami
  • Investigador principal: Hansel E Tookes, MD, MPH, University of Miami
  • Investigador principal: Armen Henderson, MD, University of Miami

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de mayo de 2027

Finalización primaria (Estimado)

1 de julio de 2030

Finalización del estudio (Estimado)

1 de julio de 2030

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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