HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
PrEP ED
2 other identifiers
interventional
250
1 country
1
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 electronic health record (EHR) based HIV prediction tool and prior success with a robust ED HIV navigation program, a PrEP navigator would approach patients in the Parkland ED for PrEP initiation. Through standard care prescribing by their ED clinician, subjects would leave the ED with a prescription for rapid-start oral PrEP and a clinic appointment to persist on the PrEP modality of their choice which will include long-acting injectable options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
June 2, 2026
May 1, 2026
1.6 years
March 2, 2026
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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.
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.
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.
Immediate, based on self report questionnaires.
Assess subjects' preferred PrEP product choice and reasoning behind their preferences.
Immediate, following self report on questionnaires and selection of treatment.
Study Arms (1)
Participants who decide to receive PrEP (rapid start)
OTHERRapid start of PrEP in the Emergency Department (ED)
Interventions
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 place a referral to Parkland ID clinic. The rapid-start TDF/FTC can be immediately filled at the co-located Parkland Anderson pharmacy where it is on formulary or other retail pharmacy of subject's choice. The participants will complete a brief survey assessing facilitators/barriers to PrEP initiation.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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):
- Clinician in the Parkland ED
- People under the age of 18 or prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- Gilead Sciencescollaborator
Study Sites (1)
Parkland Health
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor-Internal Medicine
Study Record Dates
First Submitted
March 2, 2026
First Posted
March 10, 2026
Study Start
April 8, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 03/30/2026 until 02/01/2032
- Access Criteria
- All study procedures will take place in a private location and administered only by study staff listed on the IRB. Identifiable data collection will be limited to that listed in the protocol and access limited to study staff listed on the IRB. Throughout the subject's participation in the study, data will be collected from the EHR and recorded in the study's secured UTSW REDCap database. Data is only accessible by relevant study team members. For data analysis, data from REDCap will be downloaded and safely stored on our secured, security restricted and firewall protected O:Drive for review and analysis. Data will be de-identified when exported. Study team members will adhere to institutional privacy policies and HIPAA regulations when obtaining, reviewing, and maintaining data collected. Data will be retained consistent with the UTSW research record retention requirements.
With appropriate permissions, collected data may be shared with other researchers or companies and used for future studies without additional consent. Data sharing may continue after the study ends. Research policies require protection of private and health information, but the law may allow or require certain parties to access it. Medical record information may be available to health care providers, authorized individuals, insurers, the study funder (Gilead) and its affiliates, research offices at UT Southwestern and Parkland Health, and regulatory agencies such as the FDA. Health information may be copied or transmitted electronically. Recipients may not be required to keep it private and could share it further. Study staff will use code numbers instead of names, and published results will not identify participants.