- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05530993
Exploring the Perspectives and Experiences of PrEP-eligible Black Women in Texas in Relation to Readiness for PrEP Uptake and Adherence
November 27, 2023 updated by: Mandy Hill, The University of Texas Health Science Center, Houston
The aim is to conduct two virtual focus groups (10 participants in each group) with 20 pre-exposure prophylaxis (PrEP)-eligible Black women in Houston and Austin, TX.
Participants will be assigned to focus groups with other women based on their position about PrEP uptake (considered use versus not considered use).
Focus group questions will build on an ecologic model framework to inquire about participant's intrapersonal, interpersonal, and community-level factors that influence access to and use of HIV prevention services.
This strategy aims to examine potential barriers to PrEP uptake among PrEP-eligible women in two Texas' hotspots.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Austin, Texas, United States, 78712
- The University of Texas at Austin
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
PrEP-eligible Black women in Harris County of Houston, TX and Travis County of Austin, TX will be recruited.
An e-flyer will be distributed through the social media networks of academic and community partners, with potential for sharing amongst their followers to their social media following.
Description
Inclusion Criteria:
- assigned female sex at birth
- identify as Black or African American
- 18 years of age or older
- have had condomless sex with a cisgender man within the past 12 months
- fluent in English or Spanish
- have a phone or internet access
- not currently on PrEP and have never taken PrEP
Exclusion Criteria:
- choose not to identify as Black or African American
- unable to provide informed consent for participation (e.g. have severe cognitive impairment that would interfere with their ability to consent)
- have psychological distress that would prohibit them from participating in the study
- unable or unwilling to meet study requirements
- ineligible for HIV prevention services [i.e., Human Immunodeficiency Virus (HIV) Positive]
- received a prescription for PrEP within 12 months
- has a history of PrEP uptake or is currently on PrEP
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Have considered use of PrEP
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Have not considered use of PrEP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Facilitators to readiness to adopt PrEP
Time Frame: during the focus group
|
A focus group will be used to identify facilitators to readiness to adopt PrEP (a focus group is a group interview among the study participants with the purpose of collecting information about a topic, in this case facilitators to readiness to adopt PrEP).
During the focus group, focus group participants will be asked to indicate facilitators to readiness to adopt PrEP, and these facilitators to readiness will be recorded at the time of the focus group.
These facilitators to readiness identified during the focus group will be reported categorically.
|
during the focus group
|
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Barriers to readiness to adopt PrEP
Time Frame: during the focus group
|
A focus group will be used to identify barriers to readiness to adopt PrEP (a focus group is a group interview among the study participants with the purpose of collecting information about a topic, in this case barriers to readiness to adopt PrEP).
During the focus group, focus group participants will be asked to indicate barriers to readiness to adopt PrEP, and these barriers to readiness will be recorded at the time of the focus group.
These barriers to readiness identified during the focus group will be reported categorically.
|
during the focus group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mandy J Hill, DrPH, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
June 20, 2023
Study Completion (Actual)
June 20, 2023
Study Registration Dates
First Submitted
August 25, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HSC-MS-22-0565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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