Increasing PrEP Awareness and Demand Among Black Cisgender Women

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.

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Key information

Conditions

HIV PreP

Age range

16 month–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Howard Brown Health, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP awareness materials

Behavioral

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

Primary outcomes

Number of Black cis women initiating HIV PrEP

Time frame: ~June 2023-June 2024

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

Howard Brown Health Center
National Institute of Allergy and Infectious Diseases (NIAID)
Planned Parenthood of Illinois

Registry information

Acronym: IPAD-BCW

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 9, 2023
Registry last updated: Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed