Recruiting

PrEP

Sponsor:

CAN Community Health

Code:

NCT06030557

Conditions

Hiv Prevention

Pre-Exposure Prophylaxis (PrEP)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Truvada

Study Details

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)

Study ID

NCT06030557

Start date

Apr 16, 2023

Status verified date

Feb, 2023

Completion date

Jul 10, 2025

Anticipated

Primary completion date

Jul 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Interventions

Truvada

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

Primary outcome measure

  • Outcome 1 [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

CAN Community Health

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

CAN Community Health

Recruiting

Lake Worth, Florida, United States, 33460

Contacts

CAN Community Health

Recruiting

Miami Beach, Florida, United States, 33139

Contacts

CAN Community Health

Recruiting

Miami Gardens, Florida, United States, 33055

Contacts

CAN Community Health

Recruiting

Plantation, Florida, United States, 33317

Contacts

More Information

Sponsor

CAN Community Health

Last update posted

Sep 11, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAN Community Health on 2023-09-11.