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O estudo clínico NCT07279129 para HIV está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Decision Support Tool to Integrate PrEP Into Emergency Departments Fase I 120 Personalizado

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07279129 vai avaliar prevenção para HIV. Este é um estudo intervencionista de Fase I. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 15 de janeiro de 2027, com o objetivo de incluir 120 participantes. Coordenado por a Universidade George Washington e deve ser concluído em 9 de setembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de dezembro de 2025.
Resumo
This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimiz...Mostrar mais
Descrição detalhada
Despite its promise, rates of pre-exposure prophylaxis (PrEP) uptake in the United States (US) have been modest. Innovative strategies are needed to improve access to PrEP in venues where patients with a high-risk of HIV acquisition may present for care, such as the Emergency Department (ED) or Urgent Care (UC). Recent pilot studies have tested rapid PrEP initiation at the George Washington University (GWU) ED in Was...Mostrar mais
Título oficial

A Pilot Feasibility Study to Integrate PrEP Into Emergency Departments Using Decision Support Tools

Condições médicas
HIV
Outros IDs do estudo
  • NCR256674
Número NCT
NCT07279129
Data de início (real)
2027-01-15
Última atualização postada
2025-12-12
Data de conclusão (estimada)
2028-09-09
Inscrição (estimada)
120
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Palavras-chave
PrEP
Emergency departments
Decision support tools
HIV prevention
Propósito principal
Prevenção
Alocação do design
Não randomizado
Modelo de intervenção
Sequencial
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoED-PrEP
In Phase 1 (Pre-DST) PrEP eligible patients who have agreed to PrEP will receive a PrEP prescription facilitated by a PrEP Champion; there will be no structured engagement intervention (i.e., the DST).
PrEP Delivery
Participants enrolled during Phase 1 will receive a 14-day prescription of TDF/FTC or FTC/TAF before leaving the ED and an appointment with a community PrEP provider. The Champion will provide brief HIV prevention and PrEP medication counseling including proper dosing, missed doses, review of medication side effects and efficacy, and risk reduction counseling including condom use. Participants will receive a PrEP inf...Mostrar mais
ExperimentalED-PrEP + DST
In Phase 2 (Post-DST) PrEP Champions will integrate the DST into all patient encounters, facilitating the use of the DST as well as the provision of any identified resources.
Decision support tool
Participants enrolled during Phase 2 will engage in all the activities from Phase 1 and will receive the DST intervention. The DST will be designed and programmed to generate results if tablet-based (or to be easily manually scored if paper-based) to display the participant's PrEP knowledge and intention score, self-efficacy score, level of self-perceived risk, as well as generate a list of unmet needs. Upon completi...Mostrar mais
PrEP Delivery
Participants enrolled during Phase 1 will receive a 14-day prescription of TDF/FTC or FTC/TAF before leaving the ED and an appointment with a community PrEP provider. The Champion will provide brief HIV prevention and PrEP medication counseling including proper dosing, missed doses, review of medication side effects and efficacy, and risk reduction counseling including condom use. Participants will receive a PrEP inf...Mostrar mais
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Number of participants who self-report taking PrEP in the past 4 months and have any TFV-DP detected in DBS
PrEP persistence defined as self-report of taking PrEP in the past 4 months and having any TFV-DP detected in DBS
4 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Number of participants who fill a PrEP prescription from the ED
PrEP initiation defined as the number of participants who fill a PrEP prescription from the ED confirmed via EMR
1 week
Number of participants who attend a PrEP clinic visit
Initial PrEP linkage defined as the number of participants who attend a clinic visit confirmed via self-report or clinic record
1 week
Number of participants who self-report PrEP adherence
PrEP adherence defined as the number of participants who report taking PrEP over the last 4-7 days in a 1-week period
4 months
Number of participants with biological PrEP adherence (effective short-term use)
Presence of TFV on urine assay at 1 month
1 month
Number of participants with biological PrEP adherence (effective long-term use)
Presence of TFV-DP on DBS test at 4 months
4 months
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  • English-speaking
  • Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)
  • Medically stable ED/UC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)

  • Currently taking PEP, PrEP, or present with signs/symptoms of acute HIV infection
  • Pregnant
  • Currently taking a nephrotoxic medication
  • Diagnosed with medical conditions that are contraindicated with use of TDF/FTC or TAF/FTC
  • Have a comorbid medical or psychiatric condition that would make PrEP adherence or ongoing follow-up care difficult
  • Admission to the hospital
  • Are in police custody/prisoner during the ED visit
George Washington University logoUniversidade George Washington
Contato central do estudo
Contato: Amanda D Castel, 202-994-8325, [email protected]
Contato: Bhakti Hansoti, 410-735-7077, [email protected]
2 Locais do estudo em 1 países

District of Columbia

George Washington University Emergency Department, Washington D.C., District of Columbia, 20037, United States
Amanda D Castel, Contato, 202-994-8325, [email protected]
Amanda D Castel, Investigador principal

Maryland

Johns Hopkins Hospital Emergency Department, Baltimore, Maryland, 21287, United States
Bhakti Hansoti, Contato, 410-735-7077, [email protected]
Bhakti Hansoti, Investigador principal