Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05896423 |
| Other study ID # |
STU00218358 |
| Secondary ID |
P30AI117943 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2023 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
