NCT05709860

Brief Summary

This study is being conducted to investigate a strategy that may improve knowledge and uptake of pre-exposure prophylaxis for HIV prevention (PrEP) among cisgender women in primary care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 29, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 21, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

January 17, 2023

Results QC Date

March 18, 2025

Last Update Submit

May 21, 2025

Conditions

HIV InfectionsElectronic Health RecordPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • PrEP Uptake (Use)

    PrEP uptake will be measured during the intervention period between study arms to investigate the effects of the EMC2 PrEP strategy.

    6 months

Secondary Outcomes (7)

  • PrEP Knowledge

    2-6 weeks

  • Perceived Risk of HIV

    2-6 weeks

  • PrEP Attitudes

    2-6 weeks

  • Health Literacy

    2-6 weeks

  • Health Activation

    2-6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care includes: 1) no specific materials to promote PrEP knowledge or uptake among women in primary care, and 2) variable physician counseling on PrEP among women with increased vulnerability to HIV.

The EMC2 PrEP Strategy

ACTIVE COMPARATOR

The EMC2 PrEP Strategy will utilize health information and consumer technologies to automatically deposit an interactive PrEP educational material into the patient portal of women with clinically indicated increased vulnerability to HIV. The material will: 1) promote PrEP knowledge, and 2) prompt discrete scheduling of a dedicated PrEP visit among those interested.

Behavioral: EMC2 PrEP Educational ToolBehavioral: Discrete Scheduling of a Dedicated PrEP Visit

Interventions

EMC2 PrEP Educational ToolBEHAVIORAL

Patients will receive an interactive PrEP Educational Tool. This interactive tool will be securely sent via the patient portal. After logging into their portal, patients will have the opportunity to review the information on their own time.

The EMC2 PrEP Strategy
Discrete Scheduling of a Dedicated PrEP VisitBEHAVIORAL

Within the interactive PrEP Educational Tool, patients who choose to will have the opportunity to discretely schedule a dedicated PrEP visit with a primary care clinician trained on PrEP delivery. The clinician will have time reserved to allow for 'rapid' scheduling.

The EMC2 PrEP Strategy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • HIV negative
  • have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis
  • and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months
  • currently engaged in primary care
  • not currently using PrEP

You may not qualify if:

  • severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Pack A, O'Conor R, Vasiloff R, Liebovitz D, Masters MC, Alcantara K, Smith R, Wismer G, Tatz R, Yeh F, Curtis LM, Hur S, Bailey SC. An electronic health record-based strategy to increase PrEP decision-making among cisgender women in primary care: results of a randomized pilot study. BMC Health Serv Res. 2025 Apr 24;25(1):589. doi: 10.1186/s12913-025-12745-2.

    PMID: 40269861DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Research Assistant Professor
Organization
Northwestern University
allison.pack@northwestern.edu
312-503-0274

Study Officials

  • Allison Pack, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 2, 2023

Study Start

November 29, 2023

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

May 30, 2025

Results First Posted

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)