PrEP Uptake PerspectivesNCT05530993
Exploring the Perspectives and Experiences of PrEP-eligible Black Women in Texas in Relation to Readiness for PrEP Uptake and Adherence
An observational study of PrEP Uptake Perspectives and PrEP Uptake Experiences, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Uptake Perspectives, PrEP Uptake Experiences, PrEP Adherence Perspectives
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2023to 20 Jun 2023
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas at Austin
Austin, Texas, 78712
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Have considered use of PrEP | Not described | |
| Have not considered use of PrEP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitators to readiness to adopt PrEP
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.
Measured: during the focus group
Barriers to readiness to adopt PrEP
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.
Measured: during the focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Feb 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrEP Uptake PerspectivesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mandy Hill, The University of Texas Health Science Center, Houston
- Investigators
- Mandy J Hill, DrPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530993
- Sponsor's protocol ID
- HSC-MS-22-0565
- Status last verified
- Nov 2023
- First submitted
- 25 Aug 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aidoo-Frimpong G, Mangum LC, Sophus AI, Gray A, Hill MJ. Awareness, Acceptability, and Preferences for Pre-exposure Prophylaxis Modalities Among Black Women: A Critical Review and Brief Report of a Pilot Study. AIDS Educ Prev. 2026 Apr;38(2):135-150. doi: 10.1521/aeap.2026.38.2.135.
PubMed 42048235Hill MJ, Sophus AI, Gray A, Wright JI. A Qualitative Study Exploring How the Perspectives and Experiences of Cisgender Black Women Inform Their Readiness to Consider Pre-Exposure Prophylaxis for HIV Prevention. Int J Environ Res Public Health. 2025 Apr 3;22(4):558. doi: 10.3390/ijerph22040558.
PubMed 40283782
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Perspectives and Experiences of PrEP-eligible Black Women in Texas in Relation to Readiness for PrEP Uptake and Adherence
- ClinicalTrials.gov ID
- NCT05530993
- Acronym / sponsor ID
- HSC-MS-22-0565
- Conditions
- PrEP Uptake Perspectives, PrEP Uptake Experiences, PrEP Adherence Perspectives, PrEP Adherence Experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 7 Sep 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Have considered use of PrEP | – | – |
| Have not considered use of PrEP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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 29 Nov 2023.
- Derived from this study: PubMed 42048235Aidoo-Frimpong G, Mangum LC, Sophus AI, Gray A, Hill MJ. Awareness, Acceptability, and Preferences for Pre-exposure Prophylaxis Modalities Among Black Women: A Critical Review and Brief Report of a Pilot Study. AIDS Educ Prev. 2026 Apr;38(2):135-150. doi: 10.1521/aeap.2026.38.2.135.
- Derived from this study: PubMed 40283782Hill MJ, Sophus AI, Gray A, Wright JI. A Qualitative Study Exploring How the Perspectives and Experiences of Cisgender Black Women Inform Their Readiness to Consider Pre-Exposure Prophylaxis for HIV Prevention. Int J Environ Res Public Health. 2025 Apr 3;22(4):558. doi: 10.3390/ijerph22040558.
- Individual participant dataSharing planned: No
Related trials for PrEP Uptake Perspectives
Not yet recruitingObservational study
PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)
PrEP, PrEP Adherence Experiences
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.
Mandy J Hill, DrPH principal investigator
The University of Texas Health Science Center, Houston
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 PrEP Uptake Perspectives and PrEP Uptake Experiences, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 7 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 29 Nov 2023. 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?
Facilitators to readiness to adopt PrEP (time frame: during the focus group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530993, which also lists 2 linked publications.
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 29 Nov 2023.