PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure Prophylaxis (PrEP)

Status unconfirmed

Conditions studied: Hiv Prevention, Pre-Exposure Prophylaxis (PrEP)

In brief

During the initial encounter, the nurses will complete program enrollment forms (consents and disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems, focused physical exam with emphasis on sexually transmitted infections and signs of seroconversion is provided, including identifying signs of genitourinary infection. The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing order. At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health indicators, and social determinants of health, such as access to transportation and housing status, are recorded. Process evaluation will be performed to determine relationships of these variables and PrEP adherence, implementation (12 months), and continuation/dissemination (year 2) phases of the study.

Key facts

Study ID

NCT06030557

Run by

CAN Community Health

People needed

210

Starts

2023-04-16

Expected to finish

2025-07-10

Last updated by the study team

2023-09-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Gay and bisexual men of color, cisgender women of color, and transgender women, transgender men, heterosexual men, Caucasian cisgender men and women individuals at risk for HIV and STI's, Individuals completing nPEP services. Between the ages of 18 and 65.

You may not qualify if…

• Minors younger than age 18, individuals not at risk for HIV, HIV positive status, HIV seroconversion, current or historical Hepatitis B virus infection, patients who are candidates for Truvada; patient has a history of renal dysfunction or eGFR values are below 60 mL/min, patients who are candidates for Descovy; patient has advanced CKD or an eGFR less than 30 mL/min, Patient is taking contraindicated medications*, patient has a positive pregnancy test or is breastfeeding. Any other clinical or psychosocial condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements

Where it is running

• CAN Community Health — Fort Lauderdale, Florida, United States (enrolling)
• CAN Community Health — Lake Worth, Florida, United States (enrolling)
• CAN Community Health — Miami Beach, Florida, United States (enrolling)
• CAN Community Health — Miami Gardens, Florida, United States (enrolling)
• CAN Community Health — Plantation, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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