Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06030557 |
| Other study ID # |
IN-US-412-6439 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2023 |
| Est. completion date |
July 10, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
CAN Community Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The following study design is an alternative to the existing protocol at CAN clinics. The
point of care will be RN-led, as opposed to the Provider. The Provider will still retain
safety and protocol oversight, but the RN will make the clinical decisions. Findings of this
study will demonstrate the relative efficacy of the nurse-led PrEP services in comparison to
the traditional provider-led services.
During the initial three months of the study period, CAN will hire and train two registered
nurses with licensure in the State of Florida. These nurses will work with Shannon DiPalmo,
MSW, CANs Vice President for Community Engagement and other staff to identify community,
faith-based organizations, and colleges who serve the priority populations. CAN will
establish memoranda of agreement with these organization to allow regular visits by nurses to
meet with participants in safe, private spaces where PrEP services can be provided in person
or through telehealth.
When these relationships are established, the RNs will work with the partner to schedule PrEP
encounters. CAN plans to enroll a minimum of 210 study participants at a minimum of six
different locations.
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 (e.g.,
discharge, lesions, or pain), rectal infection (anal pain, tenesmus, or discharge). This exam
also includes an inspection of the oral mucosa for signs of primary or secondary syphilis.
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. The RN schedules a 2-week follow-up phone call with the patient and a 4-week follow-up
and lab-draw visit. At the 2-week follow-up call, the RN will ensure all lab results have
been reviewed with the patient and discuss PrEP tolerability and adherence. At the 4-week
follow-up, the RN will repeat steps in the initial visit, facilitate renewal of the
electronic medication prescription, and review medication adherence.
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. Outcome evaluation will occur after
start-up and will include pre and post-enrollment rates of STI, rates of unplanned pregnancy,
and post enrollment HIV seroconversion. The demographics characteristics of clients enrolled
in the study will be compared to CANs existing PrEP populations served in traditional
clinical settings. Qualitative information on barriers to PrEP initiation, barriers to
adherence, and rationale for participation interruption/termination will be obtained by the
PrEP nurses during monthly check-in appointments and telephone interviews. A portion of the
study nurses' FTE will be dedicated to rapid analysis and reporting. This work will be
managed in-kind by the Principal Investigator, Dr. Laura Armas-Kolostroubis, MD with 5% of
FTE, with co-investigators Aleida Torres, DHSc., APRN with 30% FTE and Katy Wendel R.N., BSN
with 15% FTE. Additional statistical analysis will be provided by Max Wilson, Ph.D. Final
study publications will be completed by a panel of CAN stakeholders, including medical and
prevention subject-matter experts (SMEs) and priority population members.
