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New treatment option for HIV Pre-exposure Prophylaxis
Official title HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
ClinicalTrials.gov ID: NCT07462611
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Primary study (ED patients):
- 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
You likely can't join 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...
See the full eligibility criteria
- Primary study (ED patients):
- 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
- 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 people (ED clinicians): Inclusion criteria:
- Clinician in the Parkland ED Exclusion criteria:
- People under the age of 18 or prisoners.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.