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

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.