Encouraging Multiple PrEP Options for Women Engaged in PRimary Care

NCT ID: NCT06785038

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-07-31

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.

Conditions

PrEP Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Attention Control

Group Type: OTHER

Attention Control

Intervention Type: BEHAVIORAL

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.

EMPOWER Strategy

Group Type: EXPERIMENTAL

EMPOWER Strategy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PrEP Education; PrEP Scheduling; PrEP Counseling Support; PrEP Prescribing Support

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Stacy C Bailey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stacy C Bailey, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stacy C Bailey, PhD, MPH

Role: CONTACT

stacy-bailey@northwestern.edu

312-503-5595

Guisselle Wismer, MPH

Role: CONTACT

guisselle.wismer@northwestern.edu

312-503-3272

Facility Contacts

Guisselle Wismer, MPH

Role: primary

guisselle.wismer@northwestern.edu

312-503-3272

Evelyn Velazquez

Role: backup

evelyn.velazquez@northwestern.edu

Other Identifiers

STU00220528

Identifier Type: -

Identifier Source: org_study_id