Nurse-led management for high-risk patients seeking HIV prevention
PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure
This study is testing whether care from nurses can help high-risk patients get and stay on HIV prevention medication better than regular doctor visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | CAN Community Health Academic / other |
| Locations | 5 sites (Fort Lauderdale, Florida and 4 other locations) |
| Trial ID | NCT06030557 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of nurse-led management for high-risk patients seeking pre-exposure prophylaxis (PrEP) for HIV prevention. Registered nurses will conduct initial assessments, including medical history and risk evaluations, and provide necessary testing and counseling. Participants will receive a supply of PrEP medication and follow-up visits to monitor their health and attitudes towards PrEP. The study aims to compare the outcomes of nurse-led services with traditional provider-led services in community settings.
Who should consider this trial
Good fit: Ideal candidates include gay and bisexual men of color, cisgender women of color, transgender individuals, and other at-risk adults aged 18 to 65.
Not a fit: Patients who are HIV positive, not at risk for HIV, or have contraindications to PrEP medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance access to PrEP services and improve health outcomes for high-risk populations.
How similar studies have performed: Previous studies have shown promising results with nurse-led interventions in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fort Lauderdale, Florida and 4 other locations
- CAN Community Health — Fort Lauderdale, Florida, United States (Recruiting)
- CAN Community Health — Lake Worth, Florida, United States (Recruiting)
- CAN Community Health — Miami Beach, Florida, United States (Recruiting)
- CAN Community Health — Miami Gardens, Florida, United States (Recruiting)
- CAN Community Health — Plantation, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.