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Encouraging Multiple PrEP Options for Women Engaged in PRimary Care

Encouraging Multiple PrEP Options for Women Engaged in PRimary Care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06785038
Acronym
EMPOWER
Enrollment
132
Registered
2025-01-20
Start date
2025-05-19
Completion date
2027-01-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PrEP Education

Keywords

PrEP, cisgender women, primary care, electronic health record

Brief summary

This study will address the significant yet often overlooked problem of HIV among cisgender women. To do this, researchers will adapt and test a multilingual technology-based strategy supporting informed decision-making for PrEP in primary care. Specifically, researchers will use the electronic health record to securely send women multimedia educational materials in English or Spanish about PrEP, and facilitate electronic scheduling of PrEP visits - if women decide they are interested. Choice is critical.

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.

Interventions

BEHAVIORALEMPOWER 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.

BEHAVIORALAttention 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PrEP KnowledgeTwo to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accountsPrEP 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStacy C Bailey, PhD, MPH

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026