Implementation of PrEP Care Among Women in Family Planning Clinics

NCT ID: NCT06335121

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2027-06-30

Brief Summary

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This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.

Detailed Description

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Conditions

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PrEP Uptake HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention - Aim 2

During the intervention period, PPIL staff will capture PrEP eligible women through an updated electronic flag alert in the patient's electronic medical record. The flag will alert to offer the patient PrEP navigation services and implement adapted POWER Up intervention strategies according to training.

Group Type EXPERIMENTAL

POWER Up strategies -

Intervention Type BEHAVIORAL

Clinics will implement adapted POWER Up intervention strategies when a patient is flagged as PrEP eligible.

Control - Aim 2

PPIL health centers will follow current PrEP navigation procedures using current monitoring system.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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POWER Up strategies -

Clinics will implement adapted POWER Up intervention strategies when a patient is flagged as PrEP eligible.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Eligible participants include ciswomen presenting at a PPIL health center with a positive STI test (syphilis, gonorrhea, or chlamydia) and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling.

Exclusion Criteria

\- Participants will be excluded if they are not PrEP eligible, have a negative STI test, or are not identified in the EHR.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Planned Parenthood of Illinois

UNKNOWN

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sadia Haider, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Amy Johnson, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine

Central Contacts

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Cristina MA Barkowski, MSW

Role: CONTACT

312-942-6382

Kate P Palmer, MPH

Role: CONTACT

312-563-9389

Other Identifiers

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1R01MH134264

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21120602

Identifier Type: -

Identifier Source: org_study_id

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