Encouraging Multiple PrEP Options for Women Engaged in PRimary Care

NCT06785038 | Active Not Recruiting DMC

• 1 other identifier: STU00220528
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Education

Keywords

PrEP; cisgender women; primary care; electronic health record

Outcome Measures

Primary Outcomes (1)

• PrEP Knowledge

  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

Study Arms (2)

Attention Control

OTHER

Behavioral: Attention Control

EMPOWER Strategy

EXPERIMENTAL

Behavioral: EMPOWER Strategy

Interventions

EMPOWER Strategy 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.

Also known as: PrEP Education, PrEP Scheduling, PrEP Counseling Support, PrEP Prescribing Support

EMPOWER Strategy

Attention Control 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.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals will be excluded if they have any:
• \- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

• Stacy C Bailey, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: May 19, 2025
• Primary Completion: February 19, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: April 2026 for at least 3 years
• Access Criteria: We will submit de-identified data to the NIMH Data Archive.

Locations

US (1)