Implementation of PrEP Care Among Women in Family Planning Clinics

HIV Clinical Trial

Official title:

Implementation of PrEP Care Among Women in Family Planning Clinics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335121
• Other study ID #: 21120602
• Secondary ID: 1R01MH134264
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Rush University Medical Center
• Contact: Cristina MA Barkowski, MSW
• Phone: 312-942-6382
• Email: cristina_m_barkowski[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• PrEP Uptake
• Prevention

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Rush University Medical Center	National Institute of Mental Health (NIMH), Planned Parenthood of Illinois, University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Receipt of PrEP refills among Black women accessing FP services at 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