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Pre-Exposure Prophylaxis (PrEP)PrEP-RNNCT05095818

Impact of Nursing Involvement on Implementation of HIV Prevention Services

A study testing PrEP-RN in people with Pre-Exposure Prophylaxis (PrEP), run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pre-Exposure Prophylaxis (PrEP)
What is being tested?
PrEP-RN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 17 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Impact of Nursing Involvement on Implementation of Human Immunodeficiency Virus (HIV) Prevention Services in an Academic Obstetric/Gynecologic (OB/GYN) Clinical Setting

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.

Read the 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.

Being tested
PrEP-RN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEP-RNOther

    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).

Study groups in NCT05095818
Study groupRoleWhat they receive
Standard of Care with EMR EnhancementsNo interventionParticipants in this arm will receive Standard of Care with EMR Enhancements.
Standard of Care with EMR Enhancements and PrEP-RNExperimentalParticipants in this arm will receive Standard of Care with EMR Enhancements and PrEP-RN.
Receives: Other: PrEP-RN

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the study interval, up to 16 months

Secondary outcomes (1)
  1. Percentage of women at risk for HIV who initiate PrEP

    Measured by the number of PrEP laboratory tests and the number of PrEP prescriptions ordered.

    Measured: During the study interval, up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start1 Apr 2021
  3. Primary completion17 Nov 2021
  4. Study completion17 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05095818
Sponsor's protocol ID
IRB00209380
Acronym
PrEP-RN
Status last verified
Sep 2025
First submitted
13 Oct 2021
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PrEP-RN in people with Pre-Exposure Prophylaxis (PrEP), run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Awareness of PrEP as assessed by percentage of at-risk women who receive HIV risk prevention counseling (time frame: During the study interval, up to 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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