Encouraging Multiple PrEP Options for Women Engaged in PRimary Care (EMPOWER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will adapt and pilot test a technology-enabled, primary care-based, health literacy strategy to empower women with increased vulnerability to HIV to make informed decisions about PrEP.
Nearly 20% of new HIV infections in the United States (US) occur among cisgender women, with women of color disproportionately affected. Pre-exposure prophylaxis (PrEP) is a safe, effective, and empowering option for HIV prevention women can initiate and use without partner negotiation. Yet most women are unaware PrEP is an option for them. With primary care representing the frontline of healthcare for most adult women, it is an ideal setting to promote PrEP awareness and informed decision-making. Importantly, women themselves have asked for PrEP discussions to be normalized in primary care and multiple studies have shown that women value talking with clinicians about PrEP. Unfortunately, many primary care providers (PCPs) lack the time, resources, and experience needed to counsel women on PrEP during busy, routine visits. Our proposed R34 Encouraging Multiple PrEP Options for Women Engaged in PRimary Care (EMPOWER) therefore offers a pragmatic and innovative approach to the delivery of PrEP information to women in primary care. The EMPOWER strategy addresses well-documented barriers and 'missed opportunities' for HIV prevention among cisgender women and supports informed PrEP decision-making by: 1) identifying women in primary care; 2) delivering understandable, actionable, and non-stigmatizing PrEP education, in multiple formats and languages, directly and securely to women via the patient portal; 3) enabling women to discreetly self-schedule a visit to discuss PrEP options with either their own PCP or with a female PCP who has years of experience in PrEP delivery; and 4) supporting PCP counseling via clinical decision support that provides standardized, patient-centered language to guide PrEP discussions and 'smart sets' to facilitate PrEP prescribing, when desired. Our specific aims are to: 1) Adapt and coordinate the EMPOWER strategy to support informed decision-making among diverse cisgender women with increased vulnerability to HIV seen in primary care; 2) Pilot test the efficacy of the EMPOWER strategy, compared to an attention control, on PrEP knowledge, stigma, and future intention to use PrEP; and 3) Assess the reach, adoption, implementation, and maintenance of EMPOWER components. EMPOWER will be evaluated in Cook County, an 'Ending the HIV Epidemic' priority area. The study will be meaningfully informed by a community advisory board of diverse women, a scientific advisory board of clinicians and experts, and a community collaboration board of local organization leaders in the field of HIV.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants must:
- identify as a cisgender woman
- be aged 18 years or older
- speak English or Spanish
- be a primary care patient at the participating health center
- have an active patient portal account
- be HIV negative
- have never been prescribed PrEP
Exclusion Criteria:
Individuals will be excluded if they have any:
- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Attention Control
|
Women in this arm will be sent, via the patient portal, a CDC patient education material on benefits of physical activity.
The material will be in English or Spanish based on patient's language.
|
|
Experimental: EMPOWER Strategy
|
The EMPOWER Strategy will: 1) identify women in primary care; 2) deliver understandable, actionable, and non-stigmatizing PrEP education, in multiple formats and languages, directly and securely to women via the patient portal; 3) enable women to discreetly self-schedule a visit to discuss PrEP options via the patient portal, with either their own PCP or with a female PCP who has years of experience in PrEP delivery; and 4) support PCP counseling via clinical decision support that provides standardized, patient-centered language to guide PrEP discussions and via 'smart sets' to facilitate PrEP prescribing, when desired and appropriate.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PrEP Knowledge
Time Frame: Two to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accounts
|
PrEP knowledge is our primary outcome.
We will use an adapted version of an existing PrEP knowledge scale by Walsh (2019).
Participants will be asked 13 questions, each with true, false or don't know response options.
The number of correct answers will be summed and expressed as percentage correct.
Higher scores will represent greater PrEP knowledge.
|
Two to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accounts
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stacy C Bailey, PhD, MPH, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00220528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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