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O estudo clínico NCT07462611 (PrEP ED) para Profilaxia pré-exposição ao HIV, PrEP 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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HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study (PrEP ED) 250

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 NCT07462611 (PrEP ED) é um estudo intervencionista para Profilaxia pré-exposição ao HIV, PrEP. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 30 de março de 2026, com o objetivo de incluir 250 participantes. Coordenado por o Centro Médico Sudoeste da Universidade do Texas e deve ser concluído em 1 de abril de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 10 de março de 2026.
Resumo
Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the Parkland Memorial Hospital Emergency Department (ED) with linkage to PrEP clinic. Leveraging the previous work of the Parkland Center for Clinical Innovation (PCCI) which created an automated ele...Mostrar mais
Descrição detalhada
A dedicated PrEP navigator will approach patients in the Parkland ED who (1) request PrEP from their ED clinician, or (2) score >75% on the PCCI HIV Prediction Tool, or (3) have a history of a prior bacterial STI or (4) are seeking STI testing in the ED or (5) are referred to the navigator by an ED clinician as someone that would benefit from PrEP. In accordance with Parkland research policies, the PrEP navigator wi...Mostrar mais
Título oficial

HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department (PrEP-ED) Study

Condições médicas
Profilaxia pré-exposição ao HIVPrEP
Outros IDs do estudo
  • PrEP ED
  • STU20251670
  • IN-US-974-7790 (Outro financiamento) (Gilead Sciences, Inc)
Número NCT
NCT07462611
Data de início (real)
2026-03-30
Última atualização postada
2026-03-10
Data de conclusão (estimada)
2028-04-01
Inscrição (estimada)
250
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
PrEP
HIV pre-exposure prophylaxis
Emergency department
Propósito principal
Prevenção
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
OutroParticipants who decide to receive PrEP (rapid start)
Rapid start of PrEP in the Emergency Department (ED)
PrEP Uptake with Rapid Start
For participants who test negative for HIV and are interested in PrEP, the navigator will notify the ED clinician who will discuss starting PrEP with the subject in shared decision making as per standard care. If they decide to initiate PrEP, the ED clinician will complete standard care testing for someone starting PrEP, prescribe a 30-day supply of oral tenofovir disoproxil fumarate / emtricitabine (TDF/FTC), and pl...Mostrar mais
Pre-Exposure Prophylaxis (PrEP) Persistence
After rapid start PrEP initiation in the ED, the subject will continue on the PrEP modality of their choice in ID clinic with options to include long-acting injectables. Participants will be followed for 12 months with a final survey assessing facilitators/barriers to PrEP persistence to be administered in the final clinic visit. After study completion, participants can continue to receive PrEP through standard care.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Evaluate the feasibility of this novel navigation program of rapid-start PrEP in the ED with connection to longitudinal PrEP care and options for long-acting PrEP.
Rate of enrolled participants in the ED who attend the first ID clinic appointment. Hypothesis: Same-day oral PrEP initiation in the ED with the possibility of eventual injectable PrEP and the assistance of a PrEP navigator will lead to a 50% retention rate of people successfully navigating to PrEP clinic.
90 days after enrollment
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Among Parkland ED clinicians, assess their PrEP knowledge, experience, and perceived barriers to providing PrEP in an acute care setting before and after launch of this novel navigation program.
Pre and Post survey to be administered to ED clinicians with assessment of significant change in responses between the two surveys. Anticipate prior PrEP knowledge will be high, past experience prescribing PrEP will be low, and planned future prescribing will be low. After pilot program completion, anticipate interest in future prescribing will be higher than at program initiation
Anticipate about 6-8 months between pre and post survey
Assess PrEP persistence among people recruited from an acute care setting stratified by their PrEP product choice.
Number of days considered "PrEP covered" after 12 months from date of ED presentation stratified by PrEP modality used by the subject the most during that time period. Each filled 30-tablet oral PrEP prescription will receive 30 days, each injection of cabotegravir will receive 2 months (after initial loading period), and each injection of lenacapavir will receive 6 months. Subjects that never attend an ID follow-up appointment will be excluded.
Within the span of the 1 year follow up for each participant.
Assess the knowledge and motivation to initiate PrEP among people seeking acute care who want, need, or would benefit from PrEP.
From an initial survey administered to participants. Anticipate prior knowledge of PrEP will be low-moderate among study subjects, but interest will be moderate-high after education from a PrEP navigator.
Immediate, based on self report questionnaires.
Assess subjects' preferred PrEP product choice and reasoning behind their preferences.
Pr-EP uptake preference
Immediate, following self report on questionnaires and selection of treatment.
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
Primary study (ED patients):

  • Able to comprehend and provide signed, written informed consent prior to initiation of study procedures.

  • Negative HIV rapid test

  • At least one of the following criteria:

    • Requesting PrEP from their ED clinician
    • Score >75% on the PCCI HIV Prediction Tool
    • Prior bacterial STI diagnosis
    • Seeking STI testing
    • Referred by their ED clinician as someone who otherwise meets a CDC PrEP indication

  • Known diagnosis of HIV
  • Positive HIV rapid test
  • Current use of PrEP, which is defined for purposes of this study as use of PrEP in the last 4 weeks
  • Known hypersensitivity or allergy to any PrEP modality
  • People who do not want to follow with Parkland ID clinic for ongoing PrEP care
  • Adults unable to consent, people under the age of 18, women who are known to be pregnant or breast feeding at time of study enrollment, or prisoners

Sub-study subjects (ED clinicians):

Inclusion criteria:

• Clinician in the Parkland ED

Exclusion criteria:

• People under the age of 18 or prisoners.

University of Texas Southwestern Medical Center logoCentro Médico Sudoeste da Universidade do Texas
Responsável pelo estudo
Hayden Andrews, Investigador principal, Assistant Professor-Internal Medicine, University of Texas Southwestern Medical Center
Sem dados de contato.
1 Locais do estudo em 1 países

Texas

Parkland Health, Dallas, Texas, 75390, United States
Hayden Andrews, MD, Contato, 214-645-7863, [email protected]
Stephanie Reyes, MA, Contato, [email protected]