Adaptation and Pilot Test of an Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Our 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
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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
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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
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follow-up with patients who are prescribed PrEP via a post-visit questionnaire designed to identify barriers to PrEP uptake or use and inform the health care team so they may respond as appropriate
Our study aims are to:
Aim 1: Refine and implement an electronic health record (EHR)-based strategy as a 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual Care Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, 2) variable physician counseling on PrEP among women with increased vulnerability to HIV, and 3) no feedback loops to inform physicians of any uptake or use barriers experienced by women prescribed PrEP. |
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| Active Comparator: The EMC2 PrEP Strategy Our 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, 2) prompt discrete scheduling of a dedicated PrEP visit among those interested, and identify uptake and use barriers experienced by women prescribed PrEP; these will be sent to the clinical care team to address as appropriate. |
Behavioral: 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.
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.
Behavioral: Treatment Initiation Questionnaire and Clinic Feedback
Patients who are prescribed PrEP, as a result of their dedicated PrEP visit and independent agreement between the prescribing clinician and the patient, will be sent a treatment initiation questionnaire. This questionnaire will identify barriers to PrEP uptake and use, and will inform the clinical care team. If any barriers are identified, the clinical care team will be notified so they may address as appropriate.
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Outcome Measures
Primary Outcome Measures
- PrEP Uptake [6 months]
We will measure PrEP uptake during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.
Secondary Outcome Measures
- PrEP Knowledge [2-4 weeks]
We will use a questionnaire, developed by our study team and the scientific literature, to evaluate PrEP knowledge among study participants. Correctly answered questions will be summed for a total score. Higher scores will indicate greater PrEP knowledge.
Eligibility Criteria
Criteria
Inclusion Criteria:
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female
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HIV negative
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have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis
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and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months
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currently engaged in primary care
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not currently using PrEP
Exclusion Criteria:
- severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Northwestern University
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Allison Pack, PhD, MPH, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00217596