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NCT05095818 · ClinicalTrials.gov registry record · NA
Impact of Nursing Involvement on Implementation of HIV Prevention Services
A NA study of Preexposure Prophylaxis (PrEP), sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 440
- Enrollment target
- 1
- Study location
NCT05095818: Completed NA study of Preexposure Prophylaxis (PrEP), sponsored by Johns Hopkins University.
NCT05095818 is a NA study of Preexposure Prophylaxis (PrEP) that has completed, run by Johns Hopkins University. The registered enrollment target is 440 participants, above the 274-participant average among 3 other Preexposure Prophylaxis (PrEP) trials with a reported enrollment target (61% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095818, a NA study of Preexposure Prophylaxis (PrEP), has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 440 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Awareness of PrEP will be assessed by the percentage of at-risk women with EMR documentation of HIV risk prevention counseling.
Conditions Studied
Interventions
- OTHER PrEP-RN
Study Locations (1)
Maryland
- Johns Hopkins Outpatient Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-03-17 |
| Phase | NA |
What the finished NCT05095818 record still lists
NCT05095818 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, above the 274-participant average among 3 other Preexposure Prophylaxis (PrEP) trials with a reported enrollment target (61% higher).
The record links to 1 condition, with Preexposure Prophylaxis (PrEP) appearing as the primary indexed condition, and to 1 intervention - of which PrEP-RN is the first listed.
NCT05095818 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05095818 about?
NCT05095818 is a clinical study titled "Impact of Nursing Involvement on Implementation of HIV Prevention Services". 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 contro...
What is the current status of trial NCT05095818?
This trial is currently completed. It is a NA study. The enrollment target is 440 participants. The study started on 2021-04-01. Estimated completion is 2022-03-17.
What conditions does trial NCT05095818 study?
This clinical trial studies the following conditions: Preexposure Prophylaxis (PrEP).
What interventions are being tested in trial NCT05095818?
The interventions under investigation include: PrEP-RN (OTHER).
Who is sponsoring clinical trial NCT05095818?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05095818 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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