Impact of Nursing Involvement on Implementation of HIV Prevention Services
Condition: Pre-Exposure Prophylaxis (PrEP)
Study type: Interventional

Summary: 
      Women comprise 20% of new Human Immunodeficiency Virus (HIV) diagnoses in the United States
      (U.S.) with 86% attributed to heterosexual contact. HIV pre-exposure prophylaxis (PrEP)
      uptake among cisgender women (women who are assigned female at birth and identify as women)
      is low.

      A randomized controlled trial (RCT) will assess the feasibility and effectiveness of a
      registered nurse (RN)-led PrEP project in Obstetrics and Gynecology (OB/GYN) clinics. The
      PrEP-RN will counsel patients about their risks for HIV acquisition via telemedicine. Under
      protocol guidance, the PrEP-RN will order laboratory tests and initiate PrEP for at-risk
      women. A total of 440 at-risk cisgender women will be randomized 1:1 to the standard of care
      with electronic medical record (EMR) enhancements (e-SOC) or e-SOC with the PrEP-RN.
    

Detailed description: 
      This project will be launched in three OB/GYN outpatient clinics of a single academic medical
      system in Baltimore, Maryland. Baltimore City is one of the 57 jurisdictions targeted in the
      federal government's Ending the HIV Epidemic (EHE) Initiative.

      To test the investigators' hypothesis that an RN can effectively counsel about PrEP, initiate
      therapy, and follow patients with minimal practitioner involvement, the investigators plan to
      conduct a randomized controlled trial with two arms. The control arm will include an enhanced
      standard of care (e-SOC), which is standard of care plus electronic medical record (EMR)
      changes. These EMR changes will include best practice alerts (BPAs) that encourage nurses and
      practitioners to add HIV risk-related codes to patients' problem lists, as well as order sets
      and note templates to facilitate PrEP initiation. The intervention arm will include the
      PrEP-RN plus e-SOC.

      Patients randomized to the intervention arm will first be contacted via an electronic patient
      portal integrated with the EMR. While most of the investigators' patients utilize this
      patient portal, if a patient does not have access, this step will be skipped. Follow-up
      telephone calls will then be made to counsel patients on HIV risk factors in general, the
      patient's HIV risk factors in particular, and prevention methods, inclusive of PrEP. PrEP,
      including same-day PrEP, will be offered. If a patient declines PrEP, no additional attempts
      will be made by the PrEP-RN to counsel the patient.

      If a patient decides to initiate PrEP, the PrEP-RN will place and order the required
      laboratory tests. The PrEP-RN will utilize the PrEP order set in the EMR to order labs,
      prescribe medication electronically to the patient's pharmacy, provide patient education, and
      schedule follow-up appointments. All orders and prescriptions will be sent to the clinic's
      Medical Director for authorization.

      A Manual of Procedures was created for the PrEP-RN to carry out each step of PrEP initiation
      and follow-up. The manual outlines how to respond to abnormal tests, provide prescription
      coverage assistance, and coordinate care with other specialties as needed to address test
      results. The PrEP-RN will be responsible for follow-up visits and will contact the patients
      one-two weeks after medication initiation. At this time, the PrEP-RN will review the
      importance of daily adherence to PrEP and assess for any side effects.

      If successful, our PrEP intervention could be implemented in other settings and largely
      improve current strategies for increasing PrEP utilization among at-risk cisgender women.
    

Intervention name(s): PrEP-RN
Intervention type(s): Other
Intervention description(s): Patients randomized to the intervention arm will be counseled on HIV risk factors in general, their HIV risk factors in particular, and prevention methods, inclusive of PrEP (Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention