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Clinical Trial NCT07462611 (PrEP ED) for HIV Pre-exposure Prophylaxis, PrEP is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Texas Southwestern Medical CenterHIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study (PrEP ED) 250
Clinical Trial NCT07462611 (PrEP ED) is an interventional study for HIV Pre-exposure Prophylaxis, PrEP and is currently not yet recruiting. Enrollment is planned to begin on March 30, 2026 and continue until the study accrues 250 participants. Led by University of Texas Southwestern Medical Center, this study is expected to complete by April 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 10, 2026.
Brief Summary
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...Show More
Detailed Description
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...Show More
Official Title
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department (PrEP-ED) Study
Conditions
HIV Pre-exposure ProphylaxisPrEPOther Study IDs
- PrEP ED
- STU20251670
- IN-US-974-7790 (Other Grant/Funding Number) (Gilead Sciences, Inc)
NCT ID Number
Start Date (Actual)
2026-03-30
Last Update Posted
2026-03-10
Completion Date (Estimated)
2028-04-01
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
PrEP
HIV pre-exposure prophylaxis
Emergency department
HIV pre-exposure prophylaxis
Emergency department
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherParticipants 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...Show More 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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 CenterGilead Sciences183 active studies to exploreStudy Responsible Party
Hayden Andrews, Principal Investigator, Assistant Professor-Internal Medicine, University of Texas Southwestern Medical Center
No contact data.
1 Study Locations in 1 Countries
Texas
Parkland Health, Dallas, Texas, 75390, United States
Hayden Andrews, MD, Contact, 214-645-7863, [email protected]
Stephanie Reyes, MA, Contact, [email protected]