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

Not Applicable

Completed

Conditions: HIV Infections
Primary Health Care
Electronic Health Record

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

Registration Number: NCT05709860

Lead Sponsor: Northwestern University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The EMC2 PrEP Strategy	EMC2 PrEP Educational Tool	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.
The EMC2 PrEP Strategy	Discrete Scheduling of a Dedicated PrEP Visit	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.

Primary Outcome Measures

Name	Time	Method
PrEP Uptake (Use)	6 months	PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.

Secondary Outcome Measures

Name	Time	Method
PrEP Knowledge	2-6 weeks	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.
Perceived Risk of HIV	2-6 weeks	The 8-item Perceived Risk of HIV scale is used to assess how vulnerable an individual feels to HIV. The scale was developed in the United States and attention was paid to health literacy. Response options vary for each item, though they are measured on a 4-point Likert scale. Total score of 8 items is calculated and range from 10 to 40. Higher scores mean higher perceived risk of HIV.
PrEP Attitudes	2-6 weeks	A recently developed 5-items scale is used to assess attitudes toward PrEP, each item is measured on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). A total score is calculated and range from 5 to 25. Higher scores mean more stigma towards PrEP use.
Health Literacy	2-6 weeks	CHEW health literacy is used to assess participant's health literacy level. Participants were asked three questions about difficulty in understanding medical materials and information, the options range from all of the time to none of the time. The responses of the three questions are then categorized into limited and adequate health literacy level. We used CHEW health literacy because the measure can be conducted over phone calls.
Health Activation	2-6 weeks	A modified version of our team's 10-item Consumer Health Activation Index (CHAI) is used to assess participant's engagement in healthcare. Response options are a Likert scale; linear transformation is used to put total scores onto a 0-100 scale, with higher numbers indicating greater activation. The total scores are then categorized into 3 categories: Low (0-79), Moderate (80-94), and High (\>94).
Process Measure	2-6 weeks	The participants in the intervention group were asked two questions about 1) whether they received a PrEP decision guide, and 2) did they read or review it, to assess the acceptability of the intervention material.
Acceptability of the Strategy	2-6 weeks	Using 10-point Likert scale response options (1=very unsatisfied to 10=very satisfied), participants in the intervention group are asked to rate their satisfaction with the materials.