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Impact of Nursing Involvement on Implementation of HIV Prevention Services

NCT05095818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-09-19

No results posted yet for this study

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)

Interventions

OTHER

PrEP-RN

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).

Sponsors & Collaborators

Principal Investigators

  • Jenell Coleman, MD, MPH · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-11-17
Completion
2022-03-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095818 on ClinicalTrials.gov