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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
200
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.
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.
Northwestern University
Chicago, Illinois, United States
PrEP Uptake (Use)
PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.
Time frame: 6 months
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.
Time frame: 2-6 weeks
Perceived Risk of HIV
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.
Time frame: 2-6 weeks
PrEP Attitudes
A PrEP Attitudes 5-items scale (Walsh, 2019) 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.
Time frame: 2-6 weeks
Health Literacy
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.
Time frame: 2-6 weeks
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Health Activation
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).
Time frame: 2-6 weeks
Process Measure
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.
Time frame: 2-6 weeks
Acceptability of the Strategy
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.
Time frame: 2-6 weeks