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乔治·华盛顿大学Decision Support Tool to Integrate PrEP Into Emergency Departments I期 120 个性化治疗
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临床试验NCT07279129旨在研究预防，主要针对人类免疫缺陷病毒 (HIV)。这是一项I期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2027年1月15日开始，预计招募120名患者。该研究由乔治·华盛顿大学主导，计划于2028年9月9日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月12日。
简要概括
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...显示更多
详细描述
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...显示更多
官方标题
A Pilot Feasibility Study to Integrate PrEP Into Emergency Departments Using Decision Support Tools
疾病
人类免疫缺陷病毒 (HIV)其他研究标识符
- NCR256674
NCT编号
实际开始日期
2027-01-15
最近更新发布
2025-12-12
预计完成日期
2028-09-09
计划入组人数
120
研究类型
干预性研究
试验分期 (阶段)
I期
试验状态
尚未招募
关键词
PrEP
Emergency departments
Decision support tools
HIV prevention
Emergency departments
Decision support tools
HIV prevention
主要目的
预防
分配方式
非随机
干预模型
序贯设计
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照ED-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...显示更多 |
实验性ED-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...显示更多 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...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- 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
乔治·华盛顿大学- National Institute of Mental Health (NIMH)
- 约翰·霍普金斯大学569 个活跃的临床试验可供探索
研究中心联系人
联系人: Amanda D Castel, 202-994-8325, [email protected]
联系人: Bhakti Hansoti, 410-735-7077, [email protected]
2 位于 1 个国家/地区的研究中心
District of Columbia
George Washington University Emergency Department, Washington D.C., District of Columbia, 20037, United States
Amanda D Castel, 联系人, 202-994-8325, [email protected]
Amanda D Castel, 主要研究者
Maryland
Johns Hopkins Hospital Emergency Department, Baltimore, Maryland, 21287, United States
Bhakti Hansoti, 联系人, 410-735-7077, [email protected]
Bhakti Hansoti, 主要研究者