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.

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 will first speak to the potential subject's ED clinician for permission to approach the patient about research participation for this study. The subjects will then be approached, educated on the study and PrEP using "Dallas PrEP Education" handout (see IRB attachment), and formally consented as described below in Section 8. After signing the informed consent form, the navigator will educate the subject on all U.S. Food and Drug Administration (FDA) approved PrEP options using a standardized guide ("PrEP options pills" and "PrEP options injections," see attached IRB forms). The navigator will then administer a brief survey assessing prior knowledge/personal history with PrEP, facilitators/barriers to PrEP care, demographic information, preferred PrEP option based on the information provided, and reasons for their preferred PrEP option.

The navigator will administer a point-of-care, fingerstick HIV test if an HIV test had not already resulted on the date of enrollment. This point-of-care HIV test will be considered for research purposes and provided by the study. The result will be immediately disclosed to the subject. If the test is negative, the navigator will notify the ED clinician about the subject's interest in PrEP, and the ED clinician 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.

If a subject's rapid HIV test is positive, they will not be enrolled in the study and instead will be immediately connected to the Parkland ED HIV navigation team. As is standard care for a woman starting PrEP, a urine pregnancy test will be obtained for women who could become pregnant. If a subject is found to be pregnant on standard care testing, they will not be enrolled in the study. If a subject's creatinine clearance (CrCl) is less than 60 mL/min, tenofovir alafenamide / emtricitabine (TAF) / FTC will be used if they qualify and prefer (see "Drug handling" below). If they do not qualify for or decline TAF/FTC, PrEP initiation will be delayed to ID clinic follow-up where injectable options will be available regardless of CrCl.

If the ED clinician determines that HIV post-exposure prophylaxis (PEP) is needed but that the subject would benefit from PrEP in the future, the subject will still be enrolled in the study, but PrEP will not be prescribed. They will instead be prescribed PEP by the ED clinician as per standard care. The subject will initiate PrEP after follow-up in ID clinic and completion of PEP as per standard care. Study team medical staff, which include board-certified ID physicians who are credentialed at Parkland and well-experienced in providing PrEP and PEP, will be available to frontline ED clinicians for any consultation during the study.

The Parkland ID clinic referral will be scheduled through standard care procedures following Parkland clinical review and financial clearance policies within 30 days of ED presentation. The average time for scheduling a new Parkland ID clinic referral in FY25 was 14 days. During the initial ID clinic appointment, the subject will have standard care testing completed (HIV and bacterial STIs) and continue on the PrEP modality of their choice in shared decision making with their clinician. The subjects will be seen in ID clinic at least every 3 months as per standard care. They can stop PrEP or change PrEP modality at any time in shared-decision making with their clinician. Any decision to stop PrEP or change modality will be recorded. For subjects preferring injectable PrEP, the ID clinic will administer it as soon as accessible through standard care and continue oral bridging PrEP if any delays. We will record reasons for delays and barriers to starting injectable PrEP if encountered. If a subject elects for injectable PrEP, has been off PrEP at the time of the first injection, and is more than 7 days since last HIV test, a point-of-care HIV test will be administered in clinic by study staff. This point-of-care HIV test will be considered for research purposes and provided by the study.

At the 12-month ID clinic visit (with grace period of up to 3 months later), the navigator will administer a follow-up survey that assesses tolerability/satisfaction of PrEP, quality of life, and perceived barriers to persisting on PrEP. To assess for adherence in this real-world implementation study, we will record PrEP prescription fill history as a surrogate marker of days covered by PrEP for those on oral PrEP (where this data is available). For those on injectable PrEP, we will record days covered by PrEP as expected by their injection schedule. Subjects will exit the study after their 12-month clinic visit with the final survey but can continue receiving PrEP at Parkland ID clinic through standard care.

Primary study (ED patients):

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

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.

03/30/2026 until 02/01/2032

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.