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

NCT06030557 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2023-09-11

No results posted yet for this study

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)

Interventions

DRUG

Truvada

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

Sponsors & Collaborators

  • CAN Community Health

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-16
Primary Completion
2025-07-10
Completion
2025-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030557 on ClinicalTrials.gov