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临床试验 NCT07462611 (PrEP ED) 针对HIV暴露前预防，暴露前预防 (PrEP)目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study (PrEP ED) 250

尚未招募
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临床试验NCT07462611 (PrEP ED)是一项针对HIV暴露前预防，暴露前预防 (PrEP)的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月30日开始，预计招募250名患者。该研究由德克萨斯大学西南医学中心主导，计划于2028年4月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月10日。
简要概括
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...显示更多
详细描述
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...显示更多
官方标题

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

疾病
HIV暴露前预防暴露前预防 (PrEP)
其他研究标识符
  • PrEP ED
  • STU20251670
  • IN-US-974-7790 (其他拨款/资助编号) (Gilead Sciences, Inc)
NCT编号
NCT07462611
实际开始日期
2026-03-30
最近更新发布
2026-03-10
预计完成日期
2028-04-01
计划入组人数
250
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
PrEP
HIV pre-exposure prophylaxis
Emergency department
主要目的
预防
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
参与者组/试验组干预措施/治疗方法
其他Participants 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...显示更多
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.
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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.
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
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 logo德克萨斯大学西南医学中心
研究责任方
Hayden Andrews, 主要研究者, Assistant Professor-Internal Medicine, University of Texas Southwestern Medical Center
没有联系数据。
1 位于 1 个国家/地区的研究中心

Texas

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