Video-logs for HIV Prevention

(PrEP Trial)

Overseen By Mandy Hill, Dr.PH, MPH, HIVPCP

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: The University of Texas Medical Branch, Galveston

Must be taking: PrEP

Disqualifiers: Severe cognitive impairment, Psychological distress, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to encourage Black women in Houston to use PrEP, a medication that helps prevent HIV, by sharing health-focused video-logs (vlogs). It also seeks to motivate healthcare providers to prescribe or recommend PrEP to Black women. Participants will either watch the video series or receive standard care. Black women who have been sexually active with a man in the past six months and have internet or phone access might be a good fit. Healthcare providers in the Houston area who treat Black women and can prescribe PrEP are also invited to participate. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking HIV prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing willingness to start PrEP among participants.

What prior data suggests that this video-log series is safe for participants?

Research has shown that video-log series have been used in other health education settings, but specific safety data for this method in HIV prevention trials is lacking. As an early phase trial, the main goal is to assess the approach's safety. These trials are typically small and closely monitored to identify any potential issues.

Video-log interventions are generally considered low-risk because they involve watching videos, a passive activity. Without medications or physical procedures, there are usually fewer safety concerns compared to trials involving new drugs. Prospective participants can expect to primarily engage with educational content. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using video-logs (vlogs) for HIV prevention because this approach is innovative and engaging. Unlike traditional methods like medication or face-to-face counseling, vlogs offer an accessible and relatable way to deliver health information directly to individuals, potentially increasing awareness and understanding. This format leverages the power of visual storytelling to reach a broader audience, especially among younger, tech-savvy populations, making it a promising tool in the fight against HIV.

What evidence suggests that this video-log series is effective for increasing PrEP initiation among Black Women?

Research has shown that video blogs (vlogs) can effectively teach people about preventing HIV and encourage behavior changes. In this trial, participants in the intervention arm will watch a health-informed vlog series. Studies have found that vlogs can help viewers learn about HIV prevention methods like PrEP (pre-exposure prophylaxis). For instance, one study discovered that vlogs shared on social media spread accurate information about preventing HIV. Another study found that a web drama series successfully encouraged people to get tested for HIV and adopt prevention behaviors. These findings suggest that vlogs could be a useful tool to encourage Black women and healthcare providers to consider and promote PrEP. ^{1 2 4 6 7}

Who Is on the Research Team?

Mandy Hill, DrPH,MPH,HIVPCP

Principal Investigator

University of Texas Medical Branch, Galveston

Are You a Good Fit for This Trial?

This trial is for cisgender Black women in Houston/Harris County interested in HIV prevention, and healthcare providers willing to prescribe/refer PrEP. Specific eligibility criteria are not detailed here.

Inclusion Criteria

I was assigned female at birth.

Participants in the category for CBW must be PrEP-eligible according to CDC criteria

Participants in the category for CBW must be fluent in English

Exclusion Criteria

Participants (i.e., PrEP-eligible CBW) must not be ineligible for PrEP

Participants (i.e., PrEP-eligible CBW) must not be unable or unwilling to meet study requirements

Participants (i.e., PrEP-eligible CBW) must not 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will watch a health-informed video-log series and complete a second survey (post-test)

6 months

Baseline, 1-month, 3-month, and 6-month visits

Follow-up

Participants are monitored for willingness to access/use PrEP and adherence to PrEP regimen

6 months

1-month, 3-month, and 6-month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Video-log (vlog) series

Trial Overview

The study tests whether video logs (vlogs) tailored to either the women or their healthcare providers can increase willingness and actual initiation of PrEP for HIV prevention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 II: Standard of Care Active Control 1 Intervention

Participant will receive SOC and complete the post-test.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A systematic review of literature from 2013-2014 identified 23 published studies and 32 funded projects utilizing eHealth and mHealth strategies to enhance HIV prevention and care, indicating a growing trend in using technology for health interventions.

Despite the effective use of social media and other digital tools in engaging populations for HIV prevention, significant gaps still exist in ensuring patients are linked to care, retained in care, and initiated on antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. Muessig, KE., Nekkanti, M., Bauermeister, J., et al.[2022]

Properly designed clinical trials are crucial for advancing HIV prevention strategies, emphasizing the importance of randomization, intention-to-treat analyses, and direct assessments of clinical endpoints like HIV infection risk.

To enhance the reliability and generalizability of trial results, researchers should consider using factorial designs for interventions with complementary effects and ensure high participant retention and adherence during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing & Conducting Trials To Reliably Evaluate HIV Prevention Interventions. Fleming, TR., DeGruttola, V., Donnell, D.[2022]

Educational technologies and practices, including video, radio, and counseling, are recognized as important tools for preventing vertical HIV transmission, based on a review of 16 studies primarily from Brazil and Africa.

There is a need for ongoing training of healthcare professionals and updates to educational methods to enhance the effectiveness of these interventions, highlighting the crucial role of nurses in health counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational technologies and practices for prevention of vertical HIV transmission. Lima, ACMACC., Bezerra, KC., Sousa, DMDN., et al.[2019]

A study involving 799 HIV-negative women aged 18-45 showed that 90% of participants lived in areas with high HIV risk, highlighting the importance of geographic targeting in recruitment for vaccine trials.

The findings suggest that combining participant and partner risk behaviors with peer referral strategies effectively identifies at-risk women who are willing to participate in HIV vaccine efficacy trials, with 86% expressing willingness to join such studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment of urban US women at risk for HIV infection and willingness to participate in future HIV vaccine trials. Metch, B., Frank, I., Novak, R., et al.[2021]

A study involving 45 predominantly Caucasian gay men who have sex with men used a 4-week web diary to track sexual behaviors, revealing that web diaries can effectively collect real-time health behavior data.

Participants reported high compliance with the web diary method and generally rated it positively, although the web diary estimates differed from retrospective recall surveys, indicating a tendency to over-report certain behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A daily web diary of the sexual experiences of men who have sex with men: comparisons with a retrospective recall survey. Horvath, KJ., Beadnell, B., Bowen, AM.[2022]

The study discusses new trial designs for HIV vaccine research that must adapt to the increasing use of prevention methods like PrEP, which can lower HIV incidence among participants.

Among the proposed designs, Run-In Designs are highlighted as potentially advantageous, allowing researchers to focus on participants who either decline PrEP or show poor adherence, which could lead to more efficient trials with better resource management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing HIV Vaccine Efficacy Trials in the Context of Highly Effective Non-vaccine Prevention Modalities. Janes, H., Zhu, Y., Brown, ER.[2023]

The Guide-Enhanced Love, Sex, and Choices (GELSC) video series was effective in influencing sexual behaviors among at-risk Black urban women, with 40 participants engaging with the content after recruitment through Facebook ads.

The study demonstrated the feasibility of using Facebook for recruiting high-risk participants, achieving a recruitment rate of 10 per week, which is an improvement over previous methods, and successfully retaining participants for follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Is Your Man Stepping Out?" An Online Pilot Study to Evaluate Acceptability of a Guide-Enhanced HIV Prevention Soap Opera Video Series and Feasibility of Recruitment by Facebook Advertising. Jones, R., Lacroix, LJ., Nolte, K.[2022]

HIV pre-exposure prophylaxis (PrEP) is a highly effective method for preventing HIV infection, recommended by the WHO for individuals at substantial risk.

A new standardized dataset was developed to monitor and evaluate PrEP programs across five nations, facilitating better data comparison and public health planning, as demonstrated by its application in the Scottish National PrEP program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimum dataset for monitoring national human immunodeficiency virus pre-exposure prophylaxis (HIV PrEP) programmes: a five-nation consensus, 2019. Saunders, J., Gill, ON., Delpech, V., et al.[2022]

The study involved 76 predominantly African American women aged 18-29 and found that viewing a soap opera video about HIV risk reduction significantly decreased their expectations to engage in unprotected sex.

Using handheld computers for viewing the video and completing audio computer-assisted self-interviews (ACASI) was well-received, highlighting the potential for delivering health promotion content directly to personal devices like cell phones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soap opera video on handheld computers to reduce young urban women's HIV sex risk. Jones, R.[2022]

The study involving 67 HIV-infected men who have sex with men (MSM) showed high retention (93.4%) and compliance (72.4%) with daily diaries used to track HIV-risk behaviors over 66 days, indicating the feasibility of this method for monitoring health behaviors.

Participants preferred internet diaries (92% preference) and completed them at a higher rate (77.5%) compared to voice diaries (67.7%), highlighting the importance of modality choice in improving data collection in health studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability of Using Technology-Based Daily Diaries with HIV-Infected Young Men Who have Sex with Men: A Comparison of Internet and Voice Modalities. Cherenack, EM., Wilson, PA., Kreuzman, AM., et al.[2018]

A video-based smartphone intervention for HIV risk reduction was developed and found to be acceptable and feasible among 24 individuals in an addiction treatment clinic, with high satisfaction ratings and minimal technical issues.

The intervention may enhance knowledge about HIV and STD risk reduction, but further studies with pre-assessments and random assignments are necessary to validate these initial findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Delivery of Mobile HIV Risk Reduction Education. Phillips, KA., Epstein, DH., Mezghanni, M., et al.[2022]

A case study of a 54-year-old man with HIV showed that using videophone technology for adherence intervention significantly improved his medication adherence to 97.9% after eight sessions.

As a result of the intervention, the patient also experienced a considerable reduction in negative side effects from his HIV treatment, highlighting the potential benefits of remote adherence support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fluctuating Pattern of Over- and Under-Adherence for HAART: A Case Study from a Videophone Intervention Project. Skrajner, MJ., Camp, CJ., Heckman, TG., et al.[2021]

The MTN-016 study successfully enrolled 420 pregnant women and 381 infants to collect important safety data on HIV prevention agents during pregnancy, demonstrating the feasibility of a multinational pregnancy exposure registry.

With a high retention rate of 86% for infants completing the 12-month follow-up, the study shows that it is possible to effectively gather perinatal safety data alongside ongoing clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. Mhlanga, FG., Noguchi, L., Balkus, JE., et al.[2019]

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Researchers are calling for public health interventions that can prevent HIV and sexually transmitted infections (STI) transmission; thus, we launched the first ...

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To our knowledge, this is the first study to pilot-test vlogging as an educational intervention strategy for HIV/STI prevention. Changes in ...

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This paper tests the effectiveness of an entertainment education television series, MTV Shuga, aimed at providing information and changing attitudes and ...