Impact of Nursing Involvement on Implementation of HIV Prevention Services

NCT05095818 | Completed

• 1 other identifier: IRB00209380
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Exposure Prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (1)

• Awareness of PrEP as assessed by percentage of at-risk women who receive HIV risk prevention counseling

  Awareness of PrEP will be assessed by the percentage of at-risk women with EMR documentation of HIV risk prevention counseling.

  During the study interval, up to 16 months

Secondary Outcomes (1)

• Percentage of women at risk for HIV who initiate PrEP

  During the study interval, up to 16 months

Study Arms (2)

Standard of Care with EMR Enhancements

NO INTERVENTION

Participants in this arm will receive Standard of Care with EMR Enhancements.

Standard of Care with EMR Enhancements and PrEP-RN

EXPERIMENTAL

Participants in this arm will receive Standard of Care with EMR Enhancements and PrEP-RN.

Other: PrEP-RN

Interventions

PrEP-RN OTHER

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).

Standard of Care with EMR Enhancements and PrEP-RN

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Jenell Coleman, MD, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 27, 2021
• Study Start: April 1, 2021
• Primary Completion: November 17, 2021
• Study Completion: March 17, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)