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

The University of Texas System (UT)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: HIV Prevention

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06864689

24-0363

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

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

Standard of Care

No Intervention group

Description:

Participant will receive SOC and complete the post-test.