HIV Clinical Trial - Increasing PrEP Awareness & Demand Among Black

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

HIV
PrEP

Clinical Trial Details

NCT number	NCT05896423
Study type	Observational
Source	Northwestern University
Contact	Maria Pyra, PhD
Phone	312 503 3389
Email	maria.pyra@northwestern.edu
Status	Recruiting
Phase
Start date	August 15, 2023
Completion date	December 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms