Clinical trial NCT05896423: Increasing PrEP Awareness and Demand Among Black Cisgender Women
Official title: Increasing PrEP Awareness and Demand Among Black Cisgender Women
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV
PrEP
Keywords: cis women
Black women
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Howard Brown Health Center
name: Planned Parenthood of Illinois
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-06-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black cis women living in high HIV incidence areas of Chicago

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Black cis women initiating HIV PrEP
timeFrame: ~June 2023-June 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Planned Parenthood of Illinois
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health
state: Illinois
Study officials:
affiliation: Northwestern University
name: Maria Pyra, PhD
role: PRINCIPAL_INVESTIGATOR
References: