Impact of Nursing Involvement on Implementation of HIV Prevention Services

Completed · Not applicable

Conditions studied: Pre-Exposure Prophylaxis (PrEP)

In brief

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.

Key facts

Study ID

NCT05095818

Run by

Johns Hopkins University

People needed

440

Starts

2021-04-01

Expected to finish

2022-03-17

Last updated by the study team

2025-09-19

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• not living with HIV
• weight >35 kg
• receiving OB/GYN care in our preselected clinics
• GYN patients: positive sexually transmitted infection (STI) diagnosis within past 6 months, or if seeking STI testing and a have a history of an STI
• OB patients: at least one positive answer to the following risk screen: inject illicit drugs; sex with a partner who injects illicit drugs; any past STIs; sex with a partner who has sex with both men and women; sex for money, drugs, other payment; sex with a partner currently infected with HIV; sex with more than one partner

You may not qualify if…

• symptoms or clinical signs consistent with acute HIV infection
• unknown HIV infection status
• allergies to the active substances or any excipients of PrEP
• estimated creatinine clearance of <60 mL/minute
• active Hepatitis B infection
• participating in other clinical studies related to HIV and/or antiretroviral therapy

Where it is running

• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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