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

NCT ID: NCT05709860

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2024-10-29

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.

Conditions

HIV Infections; Electronic Health Record; Primary Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.

Group Type: NO_INTERVENTION

No interventions assigned to this group

The EMC2 PrEP Strategy

The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.

Group Type: ACTIVE_COMPARATOR

EMC2 PrEP Educational Tool

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Allison Prickett Pack

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Pack, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Pack A, O'Conor R, Vasiloff R, Liebovitz D, Masters MC, Alcantara K, Smith R, Wismer G, Tatz R, Yeh F, Curtis LM, Hur S, Bailey SC. An electronic health record-based strategy to increase PrEP decision-making among cisgender women in primary care: results of a randomized pilot study. BMC Health Serv Res. 2025 Apr 24;25(1):589. doi: 10.1186/s12913-025-12745-2.

Reference Type: DERIVED

PMID: 40269861 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00217596

Identifier Type: -

Identifier Source: org_study_id