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

Northwestern University

Status: Completed

Conditions: Electronic Health Record; Primary Health Care; HIV Infections

Treatments: Behavioral: Discrete Scheduling of a Dedicated PrEP Visit; Behavioral: EMC2 PrEP Educational Tool

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05709860

STU00217596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

The EMC2 PrEP Strategy

Active Comparator group

Description:

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.

Treatment:

Behavioral: EMC2 PrEP Educational Tool

Behavioral: Discrete Scheduling of a Dedicated PrEP Visit