Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas. (PrEP)

February 11, 2026 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mandy Hill, Dr.PH, MPH, HIVPCP
  • Phone Number: 409-266-0509
  • Email: majhill@utmb.edu

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch, Galveston
        • Contact:
          • Mandy J. Hill, DrPH
          • Phone Number: 409-772-1128

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Selection criteria for participation in pilot RCT.

Eligible participants in the category for Black Women (BW) must:

  1. be a woman
  2. be 18 years of age
  3. have been sexually active with a man within the past 6 months
  4. be fluent in English
  5. have a phone or internet access

Eligible participants (i.e. PrEP-eligible BW) must not:

  1. be unable to provide informed consent/assent for participation (i.e., have severe cognitive impairment hat would interfere with their ability to consent or understand study procedures)
  2. have psychological distress that would prohibit them from participating in the study
  3. be unable or unwilling to meet study requirements
  4. be ineligible for PrEP
  5. received a prescription for PrEP within 12 months6)be unable to fill out the evaluation independently

Eligible participants in the HCP category must:

  1. be a credentialed HCP in Texas with privileges to prescribe and/or refer PrEP
  2. BW must be a part of their patient pool at the clinical setting where they practice clinically
  3. be fluent in English
  4. have a phone or internet access
  5. Live and/or practice medicine within a 60-mile radius of Houston/Harris County

Eligible HCP must not:

  1. be unable to provide informed consent for participation (e.g. have severe cognitive impairment that would interfere with their ability to consent, or ability to understand study procedures
  2. have psychological distress that would prohibit them from participating in the study
  3. be unable or unwilling to meet study requirements
  4. be unwilling to offer PrEP to BW patients
  5. have prescribed or referred PrEP to BW within the last 12 months

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Standard of Care
Participant will receive SOC and complete the post-test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with increased willingness to access or use PrEP
Time Frame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
To assess whether participation in Project ROLE versus usual care will increase the willingness of Black women to access and/or use PrEP
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
Time Frame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
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
baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of PrEP prescriptions or referrals by healthcare providers
Time Frame: 1- month, 3-months, and 6-months follow-up visits
Using the clinical notes of electronic clinical records at participating CHCs.
1- month, 3-months, and 6-months follow-up visits
Number of Black Women started to use of PrEP
Time Frame: 1- month, 3-months, and 6-months follow-up visits
To assess whether Black women started to use PrEP.
1- month, 3-months, and 6-months follow-up visits
PrEP adherence among those who initiated PrEP
Time Frame: 3-months and 6-months follow-up visits
Assess, using a urine drug screen, whether Black women who initiated PrEP adhered to the PrEP regimen.
3-months and 6-months follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mandy Hill, DrPH,MPH,HIVPCP, University of Texas Medical Branch, Galveston

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-0363
  • 1R34MH136826-01 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

Yes

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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