- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07931612
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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Tyler S Bartholomew, PhD
- Número de telefone: 305-243-4625
- E-mail: tsb61@miami.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Antiretroviral Adherence for Treatment/Prevention
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Engagement in Substance Use Disorder (SUD) Treatment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Patrocinador
Colaboradores
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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções transmitidas pelo sangue
- Transtornos Mentais, Desordem Mental
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças do aparelho digestivo
- Doenças do Fígado
- Hepatite, Viral, Humana
- Doenças Transmissíveis
- Distúrbios induzidos quimicamente
- Infecções por Flaviviridae
- Hepatite
- Transtornos Relacionados a Substâncias
- Hepatite C
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- 20251386
- R01DA065187 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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