HIV PreventionEarly Phase 1PrEPNCT06864689
Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.
A Early Phase 1 study testing Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers in people with HIV Prevention, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Selection criteria for participation in pilot RCT.
Eligible participants in the category for Black Women (BW) must:
- be a woman
- be 18 years of age
- have been sexually active with a man within the past 6 months
- be fluent in English
- have a phone or internet access
Eligible participants (i.e. PrEP-eligible BW) must not:
- 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)
- have psychological distress that would prohibit them from participating in the study
- be unable or unwilling to meet study requirements
- be ineligible for PrEP
- received a prescription for PrEP within 12 months6)be unable to fill out the evaluation independently
Eligible participants in the HCP category must:
- be a credentialed HCP in Texas with privileges to prescribe and/or refer PrEP
- BW must be a part of their patient pool at the clinical setting where they practice clinically
- be fluent in English
- have a phone or internet access
- Live and/or practice medicine within a 60-mile radius of Houston/Harris County
Eligible HCP must not:
- 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
- have psychological distress that would prohibit them from participating in the study
- be unable or unwilling to meet study requirements
- be unwilling to offer PrEP to BW patients
- have prescribed or referred PrEP to BW within the last 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Mandy J. Hill, DrPH, 409-772-1128
About this study
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.
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers
- Keywords
- Minoritized population, Video logs, PrEP, Health communication, Behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers |
| Standard of Care | No intervention | Participant will receive SOC and complete the post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with increased willingness to access or use PrEP
To assess whether participation in Project ROLE versus usual care will increase the willingness of Black women to access and/or use PrEP
Measured: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
Number of healthcare providers increased willingness to prescribe and/or refer PrEP
To assess whether participation in Project ROLE versus usual care will increase the willingness of healthcare providers to prescribe and/or refer PrEP to Black women
Measured: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month
Secondary outcomes (3)
Number of Black Women started to use of PrEP
To assess whether Black women started to use PrEP.
Measured: 1- month, 3-months, and 6-months follow-up visits
Number of PrEP prescriptions or referrals by healthcare providers
Using the clinical notes of electronic clinical records at participating CHCs.
Measured: 1- month, 3-months, and 6-months follow-up visits
PrEP adherence among those who initiated PrEP
Assess, using a urine drug screen, whether Black women who initiated PrEP adhered to the PrEP regimen.
Measured: 3-months and 6-months follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start31 Oct 2026 (estimated)
- Primary completion2 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Mandy Hill, DrPH,MPH,HIVPCP, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864689
- Sponsor's protocol ID
- 24-0363
- Other IDs
- 1R34MH136826-01
- Acronym
- PrEP
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06864689
- Acronym / sponsor ID
- PrEP / 24-0363
- Conditions
- HIV Prevention
- Keywords
- Minoritized population, Video logs, PrEP, Health communication, Behavioral intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providersParticipants 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. |
| Standard of Care | No intervention | –Participant will receive SOC and complete the post-test. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providersThis 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. | Behavioural | Intervention |
Primary outcome
Number of participants with increased willingness to access or use PrEP
Time frame: 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 Black women to access and/or use PrEP
Number of healthcare providers increased willingness to prescribe and/or refer PrEP
Time frame: 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 Black women
3 secondary outcomes
Number of Black Women started to use of PrEP
Time frame: 1- month, 3-months, and 6-months follow-up visits
Number of PrEP prescriptions or referrals by healthcare providers
Time frame: 1- month, 3-months, and 6-months follow-up visits
PrEP adherence among those who initiated PrEP
Time frame: 3-months and 6-months follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mandy Hill, DrPH,MPH,HIVPCP principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers in people with HIV Prevention, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mandy Hill, Dr.PH, MPH, HIVPCP (409-266-0509, majhill@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with increased willingness to access or use PrEP (time frame: baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.