Clinical trial NCT05709860: An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Official title: Adaptation and Pilot Test of an Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Electronic Health Record
Primary Health Care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-02-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: PrEP Uptake (Use)
timeFrame: 6 months
Secondary outcomes:
measure: PrEP Knowledge
timeFrame: 2-6 weeks
measure: Perceived Risk of HIV
timeFrame: 2-6 weeks
measure: PrEP Attitudes
timeFrame: 2-6 weeks
measure: Health Literacy
timeFrame: 2-6 weeks
measure: Health Activation
timeFrame: 2-6 weeks
measure: Process Measure
timeFrame: 2-6 weeks
measure: Acceptability of the Strategy
timeFrame: 2-6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Allison Pack, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: