NCT05530993

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

August 25, 2022

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    during the focus group

Study Arms (2)

Have considered use of PrEP

Have not considered use of PrEP

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentifies as a woman.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • assigned female sex at birth
  • identify as Black or African American
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Mandy J Hill, DrPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 7, 2022

Study Start

February 1, 2023

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations