Increasing PrEP Awareness and Demand Among Black Cisgender Women

NCT ID: NCT05896423

Last Updated: 2025-08-03

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Aim 1. Develop digital PrEP awareness materials to engage Black cis women. Using Human Centered Design and guided by (capability, opportunity, motivation, behavior; Theoretical Domains Framework)COM-B+TDF as a behavior change theory, the investigators will conduct 5 focus groups across two clinical sites with Black cis women ages 16 to 40 from high HIV-prevalence areas of Chicago (n=120 participants). This iterative process, in collaboration with the HBH communications team and led by an experienced human centered design (HCD) researcher, will lead to the development of digital PrEP awareness materials that will be piloted online. Through qualitative analysis of the focus groups, the investigators will generate knowledge regarding how TDF can be used to understand HIV prevention in this population.

Aim 2. Assess acceptability and feasibility of the PrEP awareness materials in new FQHC \& family planning clinics in Ending the HIV Epidemic (EHE) jurisdictions. Guided by implementation science frameworks and tools, the investigators will develop a toolkit and survey to accompany pilot distribution. The toolkit will provide guidance on using and adapting the awareness materials, based in the behavior change knowledge developed in aim 1. The survey will assess the acceptability, appropriateness, and feasibility of using the awareness materials, to prepare for further assessment and dissemination. The awareness materials, toolkit, and survey will be distributed locally and outside of Illinois, through Federally Qualified Health Centers and Planned Parenthood networks, as well as the Third Coast Center for AIDS Research (CFAR) and Getting to Zero networks, with a target of 20 online surveys collected.

Conditions

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HIV PrEP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBH cohort

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

PrEP awareness materials

Intervention Type BEHAVIORAL

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

PPIL cohort

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

No interventions assigned to this group

Interventions

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PrEP awareness materials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Unable to provide consent
Minimum Eligible Age

16 Months

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Howard Brown Health Center

OTHER

Sponsor Role collaborator

Planned Parenthood of Illinois

UNKNOWN

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Maria Pyra

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Pyra, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Planned Parenthood of Illinois

Chicago, Illinois, United States

Site Status

Howard Brown Health

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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P30AI117943

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00218358

Identifier Type: -

Identifier Source: org_study_id

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