Implementation of PrEP Care Among Women in Family Planning Clinics

NCT06335121 | Not Yet Recruiting

• 2 other identifiers: 211206021R01MH134264
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; Prevention; PrEP Uptake

Outcome Measures

Primary Outcomes (1)

• PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP.

  PrEP eligibility among Black women will be defined based on positive STI test and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling. Using de-identified patient-level EHR data for eligible women at each clinic within each time point, we will create a dichotomous variable for having received a prescription for PrEP during a given time period.

  1 month

Secondary Outcomes (1)

• Receipt of PrEP refills among Black women accessing FP services at 6 months.

  6 months

Study Arms (2)

Intervention - Aim 2

EXPERIMENTAL

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.

Behavioral: POWER Up strategies -

Control - Aim 2

NO INTERVENTION

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

Interventions

POWER Up strategies - BEHAVIORAL

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

Intervention - Aim 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Ciswomen will be eligible for participation in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Illinois at Chicago: collaborator
• Planned Parenthood of Illinois: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Officials

• Sadia Haider, MD, MPH

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Amy Johnson, PhD, MSW

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina MA Barkowski, MSW

CONTACT

312-942-6382; cristina_m_barkowski@rush.edu

Kate P Palmer, MPH

CONTACT

312-563-9389; kate_p_palmer@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share