PrEP EducationEMPOWERNCT06785038
Encouraging Multiple PrEP Options for Women Engaged in PRimary Care
A study testing EMPOWER Strategy in people with PrEP Education, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PrEP Education
- What is being tested?
- EMPOWER Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals will be excluded if they have any:
- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- EMPOWER Strategy, Attention Control
- Keywords
- PrEP, cisgender women, primary care, electronic health record
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER StrategyBehavioural
Also called PrEP Education, PrEP Scheduling, PrEP Counseling Support, PrEP Prescribing Support
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.
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Other | Not described Receives: Behavioral: Attention Control |
| EMPOWER Strategy | Experimental | Not described Receives: Behavioral: EMPOWER Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start19 May 2025
- Primary completion19 Feb 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP EducationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy C Bailey, Northwestern University
- Investigators
- Stacy C Bailey, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785038
- Sponsor's protocol ID
- STU00220528
- Acronym
- EMPOWER
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IDP collected throughout the trial will be included.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Multiple PrEP Options for Women Engaged in PRimary Care
- ClinicalTrials.gov ID
- NCT06785038
- Acronym / sponsor ID
- EMPOWER / STU00220528
- Conditions
- PrEP Education
- Keywords
- PrEP, cisgender women, primary care, electronic health record
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Other | Behavioral: Attention Control |
| EMPOWER Strategy | Experimental | Behavioral: EMPOWER Strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWER StrategyAlso: PrEP Education, PrEP Scheduling, PrEP Counseling Support, PrEP Prescribing SupportThe 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. | Behavioural | EMPOWER Strategy |
| Attention ControlWomen 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. | Behavioural | Attention Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. All IDP collected throughout the trial will be included.
Related trials for PrEP Education
Active, not recruiting
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Hiv, Sexually Transmitted Diseases
Active, not recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Substance Dependence, HIV (Human Immunodeficiency Virus)
Recruiting
Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
HIV Prevention, HIV Risk
Recruiting
Enhancing Wellness Through Affirming Services and Education
HIV, Mental Health Disorder
Enrolling by invitation
Welcome to PrEP School Utilizing Peer Educators to Improve Uptake of Preexposure Prophylaxis for HIV at an HBCU
HIV Prevention Program
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy C Bailey, PhD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER Strategy in people with PrEP Education, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Knowledge (time frame: Two to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accounts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.