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

Primary Purpose

HIV Infections, Electronic Health Record, Primary Health Care

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMC2 PrEP Educational Tool
Discrete Scheduling of a Dedicated PrEP Visit
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Usual Care

    The EMC2 PrEP Strategy

    Arm 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 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.

    Outcomes

    Primary Outcome Measures

    PrEP Uptake
    PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 17, 2023
    Last Updated
    June 27, 2023
    Sponsor
    Northwestern University
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05709860
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Electronic Health Record, Primary Health Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    The EMC2 PrEP Strategy
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    EMC2 PrEP Educational Tool
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Discrete Scheduling of a Dedicated PrEP Visit
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    PrEP Uptake
    Description
    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
    Secondary Outcome Measure Information:
    Title
    PrEP Knowledge
    Description
    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

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Allison Pack, PhD, MPH
    Phone
    312-503-0274
    Email
    allison.pack@northwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allison Pack, PhD, MPH
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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