An Early Phase 1 interventional study of Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers in HIV Prevention, sponsored by The University of Texas Medical Branch, Galveston. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by The University of Texas Medical Branch, Galveston · Early Phase 1, Interventional, and Prevention
The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Black Women (BW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston/Harris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.
The primary objective of this R34 proposal is to increase willingness for pre-exposure prophylaxis (PrEP) initiation and actual PrEP initiation among BW, increase willingness to prescribe/refer PrEP to BW among HCPs in Houston/Harris County, a high-priority End the HIV Epidemic (EHE) jurisdiction. The investigator hypothesizes that a video-log (vlog) series-based health communication intervention disseminated through community health centers (CHCs) and social media will increase willingness for and use of PrEP among BW. Specifically, the intervention will: 1) encourage BW to access and use PrEP; and 2) increase HCP willingness to prescribe and refer PrEP to BW. Our team will explore two aims: 1) inform and develop health messages for Project ROLE with 2023 findings from focus groups with PrEP-eligible BW and key informant interviews with HCPs providing care to BW, and 2) assess the feasibility, acceptability, and preliminary impact of Project ROLE in two real-world settings with a pilot randomized controlled trial (RCT) and a social media campaign.
Aim 1: A qualitative study using focus groups with Black women and key informant interviews with healthcare providers. (Will not be included in the clinical trial.)
Aim 2a: Pilot randomized controlled trial of a behavioral intervention with both Black women and healthcare providers.
Aim 2b: Social media marketing campaign to reach and engage Black women and healthcare providers in health communication about PrEP. (Will not be included in the clinical trial.)
The proposed research is significant because it will connect Black women to PrEP while increasing healthcare providers willingness to prescribe and refer PrEP to them using a health communication strategy that can guide the development of subsequent vlog-based interventions to address the national EHE plan.
Selection criteria for participation in pilot RCT.
Eligible participants in the category for Black Women (BW) must:
Eligible participants (i.e. PrEP-eligible BW) must not:
Eligible participants in the HCP category must:
Eligible HCP must not:
Participants will watch a health-informed video-log series and complete a second survey (post-test). The post-test will assess the same variables previously assessed in the pre-test.
Behavioral: Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers
Participant will receive SOC and complete the post-test.
This intervention is a video-log (vlog) series based health communication intervention that will be disseminated through community health centers (CHCs) and social media to increase willingness for and use of PrEP among cisgender Black women and to increase willingness to prescribe and refer PrEP among healthcare providers.
Number of participants with increased willingness to access or use PrEP
To assess whether participation in Project ROLE versus usual care will increase the willingness of Black women to access and/or use PrEP
Time frame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
Number of healthcare providers increased willingness to prescribe and/or refer PrEP
To assess whether participation in Project ROLE versus usual care will increase the willingness of healthcare providers to prescribe and/or refer PrEP to Black women
Time frame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
Number of Black Women started to use of PrEP
To assess whether Black women started to use PrEP.
Time frame: 1- month, 3-months, and 6-months follow-up visits
Number of PrEP prescriptions or referrals by healthcare providers
Using the clinical notes of electronic clinical records at participating CHCs.
Time frame: 1- month, 3-months, and 6-months follow-up visits
PrEP adherence among those who initiated PrEP
Assess, using a urine drug screen, whether Black women who initiated PrEP adhered to the PrEP regimen.
Time frame: 3-months and 6-months follow-up visits
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston