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

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05896423
Collaborator
Howard Brown Health Center (Other), Planned Parenthood of Illinois (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
300
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Increasing PrEP Awareness and Demand Among Black Cisgender Women
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of Black cis women initiating HIV PrEP [~June 2023-June 2024]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Months to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Pyra, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT05896423
Other Study ID Numbers:
  • STU00218358
  • P30AI117943
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Pyra, Assistant Professor, Northwestern University

Study Results

No Results Posted as of Jun 12, 2023