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

Early Phase 1

Recruiting

• Conditions: HIV Prevention

• Registration Number: NCT06864689
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) 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.

Detailed Description

The primary objective of this R34 proposal is to increase willingness for pre-exposure prophylaxis (PrEP) initiation and actual PrEP initiation among CBW, increase willingness to prescribe/refer PrEP to CBW 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 CBW. Specifically, the intervention will: 1) encourage CBW to access and use PrEP; and 2) increase HCP willingness to prescribe and refer PrEP to CBW. Our team will explore two aims: 1) inform and develop health messages for Project ROLE with 2023 findings from focus groups with PrEP-eligible CBW and key informant interviews with HCPs providing care to CBW, 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 cisgender 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 cisgender Black women and healthcare providers.

Aim 2b: Social media marketing campaign to reach and engage cisgender 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 cisgender 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 Timeline

• Study Start: 2025-01-31
• Study First Submitted: 2025-02-13
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with increased willingness to access or use PrEP	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 cisgender Black women to access and/or use PrEP
Number of healthcare providers increased willingness to prescribe and/or refer PrEP	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 cisgender Black women

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Medical Branch, Galveston; 🇺🇸 Galveston, Texas, United States