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Impact of Nursing Involvement on Implementation of HIV Prevention Services

CompletedNA

Sponsor: Johns Hopkins University

Conditions: Pre-Exposure Prophylaxis (PrEP)

Interventions: PrEP-RN

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 15 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (1)

Baltimore, Maryland, United States