An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy

HIV Infections Clinical Trial

Official title:

Adaptation and Pilot Test of an Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709860
• Other study ID #: STU00217596
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Allison Pack, PhD, MPH
• Phone: 312-503-0274
• Email: allison.pack[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female

• HIV negative

• have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis

• and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months

• currently engaged in primary care

• not currently using PrEP

Exclusion Criteria:

• severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

Related Conditions & MeSH terms

• Electronic Health Record
• HIV Infections
• Primary Health Care

Intervention

Behavioral:
• EMC2 PrEP Educational Tool
Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.
• Discrete Scheduling of a Dedicated PrEP Visit
Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Uptake	PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.	6 months
Secondary	PrEP Knowledge	A 10-item questionnaire, developed by the study team and the scientific literature, will be used to evaluate knowledge of pre-exposure prophylaxis among study participants. Correctly answered questions will be summed (0 to 10) for a total score. Higher scores will indicate greater PrEP knowledge.	2-6 weeks