Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT05709860
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2023-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Adaptation and Pilot Test of an Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to investigate a strategy that may improve knowledge and uptake of pre-exposure prophylaxis for HIV prevention (PrEP) among cisgender women in primary care.
Detailed Description:
Members of the study team previously developed and evaluated the Electronic health record Medication Complete Communication (EMC2) strategy to 'hardwire' provider/patient communication \& surveillance of select prescription (Rx) medications. EMC2 PrEP will adapt from the previous strategy to
* educate cisgender women in primary care who have increased vulnerability to HIV about PrEP using an interactive, health literacy-appropriate educational tool securely delivered via the patient portal
* facilitate, for those who express interest, the rapid and discrete scheduling of a dedicated PrEP clinic visit with a primary care clinician trained in PrEP delivery
The current study aims are to:
Aim 1: Refine and implement an electronic health record (EHR)-based strategy as a potential quality improvement activity that supports informed decision-making and PrEP uptake among women with increased HIV vulnerability in primary care (the EMC2 PrEP strategy).
Aim 2: Pilot-test the EMC2 PrEP strategy in primary care to determine its feasibility, acceptability, and preliminary efficacy among women with increased vulnerability to HIV.
Aim 3: Develop a standard operating protocol (SOP) for disseminating the EMC2 PrEP strategy to a national network of federally qualified health centers.
* educate cisgender women in primary care who have increased vulnerability to HIV about PrEP using an interactive, health literacy-appropriate educational tool securely delivered via the patient portal
* facilitate, for those who express interest, the rapid and discrete scheduling of a dedicated PrEP clinic visit with a primary care clinician trained in PrEP delivery
The current study aims are to:
Aim 1: Refine and implement an electronic health record (EHR)-based strategy as a potential quality improvement activity that supports informed decision-making and PrEP uptake among women with increased HIV vulnerability in primary care (the EMC2 PrEP strategy).
Aim 2: Pilot-test the EMC2 PrEP strategy in primary care to determine its feasibility, acceptability, and preliminary efficacy among women with increased vulnerability to HIV.
Aim 3: Develop a standard operating protocol (SOP) for disseminating the EMC2 PrEP strategy to a national network of federally qualified health centers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: