HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department (PrEP-ED) Study
University of Texas Southwestern Medical Center
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.
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 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, edu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 s…
Interventions
- BehavioralPrEP 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 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.
- BehavioralPre-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.
Location
- Parkland HealthDallas, Texas