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Nurse-Led PrEP program boosts HIV prevention in Women's clinics

NCT ID NCT05095818

Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a registered nurse could help women at risk for HIV learn about and start PrEP (a daily pill that prevents HIV) during OB/GYN visits. 440 women were randomly assigned to either standard care or a nurse-led program that included counseling and lab tests. The goal was to see if the nurse-led approach increased awareness and use of PrEP.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg (PrEP)
What this could lead to
If successful, this approach could make it easier for women to access HIV prevention medication during routine OB/GYN visits.
What could go wrong
This is a completed feasibility study, not a large-scale trial. The results may not apply to all clinics or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

440 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-exposure prophylaxis (PREP)

Contacts and locations

Locations

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.