HIVIPAD-BCWNCT05896423
Increasing PrEP Awareness and Demand Among Black Cisgender Women
An observational study of HIV and PrEP, run by Northwestern University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 months to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- PrEP awareness materials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 months to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Black cis women living in high HIV incidence areas of Chicago
Who may be able to join
- 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.
Who cannot join
- Unable to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of Illinois
Chicago, Illinois, 60602
Howard Brown Health
Chicago, Illinois, 60615
About this study
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.
Read the 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.
- Being tested
- PrEP awareness materials
- Keywords
- cis women, Black women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP awareness materialsBehavioural
Community-designed PrEP awareness materials - developed in the formative portion of this study
| Study group | Role | What they receive |
|---|---|---|
| HBH cohort | Rates of PrEP initiation among Black cis women at an FQHC, before and after the PrEP materials are used Receives: Behavioral: PrEP awareness materials | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ~June 2023-June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Aug 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Howard Brown Health Center, Planned Parenthood of Illinois, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Maria Pyra, Northwestern University
- Investigators
- Maria Pyra, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896423
- Sponsor's protocol ID
- STU00218358
- Other IDs
- P30AI117943
- Acronym
- IPAD-BCW
- Status last verified
- Jul 2025
- First submitted
- 31 May 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be available
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing PrEP Awareness and Demand Among Black Cisgender Women
- ClinicalTrials.gov ID
- NCT05896423
- Acronym / sponsor ID
- IPAD-BCW / STU00218358
- Keywords
- cis women, Black women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Howard Brown Health Center, Planned Parenthood of Illinois, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBH cohort | – | Behavioral: PrEP awareness materialsRates of PrEP initiation among Black cis women at an FQHC, before and after the PrEP materials are used |
| PPIL cohort | – | –Rates of PrEP initiation among Black cis woman at a family planning clinic, before and after the PrEP materials are used |
Who may qualify
- Ages
- 16 months to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Black cis women living in high HIV incidence areas of Chicago
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP awareness materialsCommunity-designed PrEP awareness materials - developed in the formative portion of this study | Behavioural | HBH cohort |
Primary outcome
Number of Black cis women initiating HIV PrEP
Time frame: ~June 2023-June 2024
Number of Black cis women at each clinic with first prescription for any form of HIV PrEP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Only aggregate data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Pyra, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and PrEP, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Black cis women initiating HIV PrEP (time frame: ~June 2023-June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.