Clinical trial NCT06864689: Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.
Official title: Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: HIV Prevention
Keywords: Minoritized population
Video logs
PrEP
Health communication
Behavioral intervention
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-07
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Selection criteria for participation in pilot RCT.

Eligible participants in the category for CBW must:

1. be assigned female sex at birth
2. be ≥18 years of age
3. be PrEP-eligible according to CDC criteria
4. be fluent in English
5. have a phone or internet access

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

1. be unable to provide informed consent/assent for participation (i.e., have severe cognitive impairment that

   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 months
6. be unable to fill out the evaluation independently

Note: All patients who are excluded will receive usual care in the clinical setting.

Eligible participants in the HCP category must:

1) be licensed and board-certified HCPs at participating clinics

Primary outcomes:
measure: Number of participants with increased willingness to access or use PrEP
timeFrame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
measure: Number of healthcare providers increased willingness to prescribe and/or refer PrEP
timeFrame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
Secondary outcomes:
measure: Number of cisgender Black Women started to use of PrEP
timeFrame: 1- month, 3-months, and 6-months follow-up visits
measure: Number of PrEP prescriptions or referrals by healthcare providers
timeFrame: 1- month, 3-months, and 6-months follow-up visits
measure: PrEP adherence among those who initiated PrEP
timeFrame: 3-months and 6-months follow-up visits
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Galveston
state: Texas
Study officials:
affiliation: University of Texas Medical Branch, Galveston
name: Mandy Hill, DrPH,MPH,HIVPCP
role: PRINCIPAL_INVESTIGATOR
References: