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

NCT ID: NCT06864689

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Standard of Care

Participant will receive SOC and complete the post-test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandy Hill, DrPH,MPH,HIVPCP

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

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University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Mandy Hill, Dr.PH, MPH, HIVPCP

Role: CONTACT

409-266-0509

Facility Contacts

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Mandy J. Hill, DrPH

Role: primary

409-772-1128

Other Identifiers

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1R34MH136826-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-0363

Identifier Type: -

Identifier Source: org_study_id

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