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

78 Participants Needed

Trial Summary

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 data supports the effectiveness of the Video-log (vlog) series treatment for HIV prevention?

Research shows that video-based interventions, like smartphone-delivered videos, are acceptable and engaging for people in HIV prevention programs. Additionally, technology-based interventions, such as videophone sessions, have been effective in improving medication adherence in people living with HIV. ^{1 2 3 4 5}

Is there any safety data available for the Video-log series used in HIV prevention trials?

The research articles provided do not contain specific safety data for the Video-log series or similar interventions in HIV prevention trials. ^{6 7 8 9 10}

How does the Video-logs for HIV Prevention treatment differ from other HIV prevention methods?

The Video-logs for HIV Prevention treatment is unique because it uses video-based interventions delivered via smartphones or handheld devices to educate and reduce HIV risk, making it accessible and engaging for users. This approach leverages technology to provide real-time, personalized education, which is different from traditional methods that may not utilize digital platforms. ^{1 5 11 12 13}

What is the purpose of this trial?

The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) 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.

Research Team

Mandy Hill, DrPH,MPH,HIVPCP

Principal Investigator

University of Texas Medical Branch, Galveston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Smartphone Delivery of Mobile HIV Risk Reduction Education. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Fluctuating Pattern of Over- and Under-Adherence for HAART: A Case Study from a Videophone Intervention Project. [2021]

4. United States 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. [2018]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Designing & Conducting Trials To Reliably Evaluate HIV Prevention Interventions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Designing HIV Vaccine Efficacy Trials in the Context of Highly Effective Non-vaccine Prevention Modalities. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Recruitment of urban US women at risk for HIV infection and willingness to participate in future HIV vaccine trials. [2021]

10. Sweden pubmed.ncbi.nlm.nih.gov

Minimum dataset for monitoring national human immunodeficiency virus pre-exposure prophylaxis (HIV PrEP) programmes: a five-nation consensus, 2019. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Educational technologies and practices for prevention of vertical HIV transmission. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States 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. [2022]