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

NCT06864689 | Not Yet Recruiting Early Phase 1 DMC

• 2 other identifiers: 24-03631R34MH136826-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention

Keywords

Minoritized population; Video logs; PrEP; Health communication; Behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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

  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

  baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month

Secondary Outcomes (3)

• Number of Black Women started to use of PrEP

  1- month, 3-months, and 6-months follow-up visits

• Number of PrEP prescriptions or referrals by healthcare providers

  1- month, 3-months, and 6-months follow-up visits

• PrEP adherence among those who initiated PrEP

  3-months and 6-months follow-up visits

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Participant will receive SOC and complete the post-test.

Interventions

Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Eligible participants in the category for Black Women (BW) must be a woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location

Study Officials

• Mandy Hill, DrPH,MPH,HIVPCP

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandy Hill, Dr.PH, MPH, HIVPCP

CONTACT

409-266-0509; majhill@utmb.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 7, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)