Implementation of PrEP Care Among Women in Family Planning Clinics

March 21, 2024 updated by: Rush University Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: POWER Up strategies -
Clinics will implement adapted POWER Up intervention strategies when a patient is flagged as PrEP eligible.
No Intervention: Control - Aim 2
PPIL health centers will follow current PrEP navigation procedures using current monitoring system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP.
Time Frame: 1 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of PrEP refills among Black women accessing FP services at 6 months.
Time Frame: 6 months
Using de-identified patient-level EHR data for eligible patients at each clinic within each time point, we will create a dichotomous variable for receiving refills of prescriptions for PrEP of those with an initial PrEP prescription.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Institute of Mental Health (NIMH)
University of Illinois at Chicago
Planned Parenthood of Illinois

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 21120602
  • 1R01MH134264 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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