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

NCT06030557 | Unknown DMC FDA Drug

• 1 other identifier: IN-US-412-6439
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hiv Prevention; Pre-Exposure Prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (1)

• Outcome 1

  Demonstrate an increase of at least 10% (n=30) of target population members enrolled in pre-exposure prophylaxis services compared to baseline (n=300)

  18 months

Interventions

Truvada DRUG

Participants will receive either Truvada or Descovy (based on prescription guidelines).

Also known as: Descovy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those who are aged 18-65 at the time of consent who are high risk patients for PrEP

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

Sponsors & Collaborators

• CAN Community Health: lead

Study Sites (5)

CAN Community Health

Fort Lauderdale, Florida, 33316, United States

RECRUITING

CAN Community Health

Lake Worth, Florida, 33460, United States

RECRUITING

CAN Community Health

Miami Beach, Florida, 33139, United States

RECRUITING

CAN Community Health

Miami Gardens, Florida, 33055, United States

RECRUITING

CAN Community Health

Plantation, Florida, 33317, United States

RECRUITING

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; emtricitabine tenofovir alafenamide

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: September 11, 2023
• Study Start: April 16, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)