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.
Able to comprehend and provide signed, written informed consent prior to initiation of study procedures.
Negative HIV rapid test
Requesting PrEP from their ED clinician
Score >75% on the PCCI HIV Prediction Tool
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
Single group
PrEP Uptake with Rapid Start
BehavioralFor 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.
Pre-Exposure Prophylaxis (PrEP) Persistence
BehavioralAfter 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.
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.
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
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.
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.
Assess subjects' preferred PrEP product choice and reasoning behind their preferences.
Pr-EP uptake preference
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University of Texas Southwestern Medical Center
Lead sponsor
Gilead Sciences
Collaborator
