Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: 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.
No Intervention
Standard of Care
Participant will receive SOC and complete the post-test.

More Details

Status
Not yet recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Mandy Hill, Dr.PH, MPH, HIVPCP
409-266-0509
majhill@utmb.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.