Increasing PrEP Awareness and Demand Among Black Cisgender Women (IPAD-BCW)

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.

Study Overview

• Status: Recruiting
• Conditions: PrEP; HIV
• Intervention / Treatment: Behavioral: PrEP awareness materials

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Maria Pyra, PhD; Phone Number: 312 503 3389; Email: maria.pyra@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Recruiting
      • Planned Parenthood of Illinois
      • Contact: Danielle Young; Phone Number: 312-622-4707
    • Chicago, Illinois, United States, 60615
      • Recruiting
      • Howard Brown Health
      • Contact: Juan Rivera; Phone Number: 872-269-3529

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Black cis women living in high HIV incidence areas of Chicago

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Howard Brown Health Center; Planned Parenthood of Illinois
• Investigators: Principal Investigator: Maria Pyra, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Black women; cis women
• Other Study ID Numbers: STU00218358; P30AI117943 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No