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.
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
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.
- Conditions
- Pre-Exposure Prophylaxis (PrEP)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PrEP-RN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted27 Oct 2021
- Study start1 Apr 2021
- Primary completion17 Nov 2021
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure Prophylaxis (PrEP)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jenell Coleman, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nursing Involvement on Implementation of Human Immunodeficiency Virus (HIV) Prevention Services in an Academic Obstetric/Gynecologic (OB/GYN) Clinical Setting
- ClinicalTrials.gov ID
- NCT05095818
- Acronym / sponsor ID
- PrEP-RN / IRB00209380
- Conditions
- Pre-Exposure Prophylaxis (PrEP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: PrEP-RNParticipants in this arm will receive Standard of Care with EMR Enhancements and PrEP-RN. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP-RNPatients 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). | Other | Standard of Care with EMR Enhancements and PrEP-RN |
Primary outcome
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
Awareness of PrEP will be assessed by the percentage of at-risk women with EMR documentation of HIV risk prevention counseling.
1 secondary outcome
Percentage of women at risk for HIV who initiate PrEP
Time frame: During the study interval, up to 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenell Coleman, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
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.