NCT05896423

Brief Summary

This study will develop HIV pre-exposure prophylaxis (PrEP) awareness materials for and with Black cis women and gather feedback on the usefulness of these materials at health care sites. The investigators will also use electronic medical records (EMR) to compare the number of Black cis women who initiate PrEP before and after the awareness materials are piloted, at the two partner research sites, Howard Brown Health and Planned Parenthood of IL. Additional federally qualified health centers and family planning clinics will review the materials and complete a survey on acceptability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

May 31, 2023

Last Update Submit

July 30, 2025

Conditions

HIVPrEP

Keywords

cis womenBlack women

Outcome Measures

Primary Outcomes (1)

  • Number of Black cis women initiating HIV PrEP

    Number of Black cis women at each clinic with first prescription for any form of HIV PrEP

    ~June 2023-June 2024

Study Arms (2)

HBH cohort

Rates of PrEP initiation among Black cis women at an FQHC, before and after the PrEP materials are used

Behavioral: PrEP awareness materials

PPIL cohort

Rates of PrEP initiation among Black cis woman at a family planning clinic, before and after the PrEP materials are used

Interventions

PrEP awareness materialsBEHAVIORAL

Community-designed PrEP awareness materials - developed in the formative portion of this study

HBH cohort

Eligibility Criteria

Age16 Months - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Black cis women living in high HIV incidence areas of Chicago

You may qualify if:

  • identify as cis women
  • identify as Black or African-American
  • self-report not living with HIV
  • reside in a high HIV incidence neighborhood in Chicago
  • aged 16 to 40, inclusive
  • able to speak English.

You may not qualify if:

  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood of Illinois

Chicago, Illinois, 60602, United States

Location

Howard Brown Health

Chicago, Illinois, 60615, United States

Location

Study Officials

  • Maria Pyra, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

August 15, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be available

Locations

US(2)