Video-Counseling + App for HIV/AIDS Management

(iVY Trial)

Overseen By Kristin Ming

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Severe cognitive impairment, active psychosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of supporting young people with HIV through video counseling and a health app. The goal is to determine if this approach manages HIV more effectively than usual care by improving virus control and addressing mental health and substance use issues. Participants will have weekly video sessions with a counselor and use an app to help remember medication and reduce feelings of isolation. It suits young adults living with HIV in California or Florida who have recently struggled with virus control and own a smartphone. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative care solutions and potentially improve their own health outcomes.

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 using video-counseling and an app to help manage HIV, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

What prior data suggests that this video-counseling and app intervention is safe for youth living with HIV?

Research has shown that using video-counseling along with a mobile health app is generally safe for people living with HIV. In earlier studies, participants found this method easy to manage. These studies involved a mobile app to help with medication schedules and social interactions, along with weekly video-counseling sessions to address mental health and other care challenges.

Reports indicate few negative effects, meaning participants did not encounter significant problems from using the video-counseling and app. The goal is to help young people with HIV adhere to their treatment plans and improve their overall health. This approach uses technology to make managing HIV easier and more personal, without adding much risk.

While specific safety data for this new trial is not yet available, past studies suggest the treatment is safe. The use of technology in healthcare is expanding, offering more personalized care options without high risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the video-counseling and app approach for HIV/AIDS management because it offers a new way to support individuals beyond traditional methods. Unlike standard treatments that focus on regular in-person visits and lab tests, this approach integrates technology with healthcare by providing weekly video-counseling sessions and an app, allowing for more personalized and flexible support. This could lead to better engagement and adherence, which are crucial for managing HIV effectively. Additionally, it allows for real-time tracking and quick adjustments to care plans, potentially improving viral load suppression rates.

What evidence suggests that the video-counseling+app intervention could be effective for HIV management?

Research has shown that phone and video counseling can help people with HIV take their medications regularly and improve their health. These methods are promising for those who struggle to remember their medicine or feel isolated. Early findings suggest that technology-based approaches might help people adhere to their medication schedules and improve their mental well-being. In this trial, participants in the intervention arm will receive a method that combines video counseling with an app to overcome obstacles to HIV care, which could be especially important for young people living with HIV. Overall, early data supports the potential effectiveness of this approach in improving health outcomes for those affected. ^{1 2 3 6 7}

Who Is on the Research Team?

Parya Sabari, PharmD

Principal Investigator

UCSF School of Medicine, Division of Prevention Science

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-29 with HIV who are not virologically suppressed, can speak English, and have a smartphone. They must be patients at certain healthcare centers in California or Florida. People with severe cognitive issues, active psychosis, hemophilia, or those unable to consent or do home finger prick tests cannot join.

Inclusion Criteria

Have access to smartphone

Receive care at an AIDS Healthcare Foundation (AHF) California or Florida-based healthcare center

Have an unsuppressed HIV viral load in the past 3 months

Exclusion Criteria

Unable or unwilling to provide consent

Evidence of severe cognitive impairment, active psychosis, or substance use that may impede ability to provide informed consent during the consent process

History of hemophilia or unable to conduct finger prick at home for the HIV viral load testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive video-counseling and access to a mobile health app for 16 weeks

16 weeks

12 weekly video-counseling sessions

Adaptive Treatment Strategy

Virologic non-responders continue with intensified video-counseling+app, while responders continue app use only for 16 more weeks

16 weeks

Follow-up

Participants are monitored for virologic suppression and mental health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Video-counseling+app

Trial Overview The study compares two methods: standard care versus a combination of video-counseling and an app designed to help manage mental health issues, substance use problems, and improve HIV treatment adherence. Participants will be randomly assigned to one of these groups to see which is more effective at achieving viral suppression.

How Is the Trial Designed?

Group I: Intervention Arm: Video-Counseling+app Experimental Treatment 1 Intervention

The video-counseling+app arm will receive 12 brief weekly counseling sessions (given over 16 weeks) with a social worker, along with access to the WYZ app to use based on their needs. After 16 weeks, participants receive another assessment and based on VL, those in the video-counseling+app arm will be categorized as intervention responders or non-responders (responder= virologically suppressed; non-responder= virologically unsuppressed. Responders in video-counseling+app arm will continue to use the app only. Non-responders in the intervention arm will continue with intensified video-counseling+app for 16 more weeks.

Group II: Standard of Care Arm Active Control 1 Intervention

The Standard of Care (SOC) arm will include the current care delivery model: regularly scheduled visits with a healthcare provider and lab testing every 3-6 months or more/less frequently depending on the individual's HIV health outcomes (e.g., VL suppression) . At each assessment, the investigators will review participant responses to examine acute need for referral for medical, psychological, or substance use services. In between assessments, researchers will also do monthly check-ins to improve retention and check contact information.

Video-counseling+app is already approved in United States for the following indications:

Approved in United States as Video-counseling and mobile health application for:

• HIV virologic suppression
• Mental health support
• Substance use support

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

AIDS Healthcare Foundation

Collaborator

Trials

19

Recruited

147,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Published Research Related to This Trial

The CARE+ tablet PC-based counseling tool was found to be usable and effective in promoting honest discussions about sensitive topics related to HIV, as participants felt more comfortable speaking to a computer than a person.

Participants expressed that while they appreciated the privacy and reduced judgment from computer counseling, they still desired some level of human interaction for support, indicating a potential for hybrid counseling approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CARE+ user study: usability and attitudes towards a tablet pc computer counseling tool for HIV+ men and women. Skeels, MM., Kurth, A., Clausen, M., et al.[2018]

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]

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]

The Masivukeni intervention, designed to improve adherence to antiretroviral therapy (ART) for HIV patients in resource-limited settings, utilizes innovative multimedia strategies to make counseling more accessible and effective for low-literacy individuals.

Developed through community-based participatory research, Masivukeni has shown high acceptability and feasibility, indicating it can be effectively implemented by lay counselors with minimal training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Masivukeni: development of a multimedia based antiretroviral therapy adherence intervention for counselors and patients in South Africa. Remien, RH., Mellins, CA., Robbins, RN., et al.[2021]

The Masivukeni multimedia intervention improved medication adherence by 10% among participants compared to an 8% decrease in the standard of care group, indicating its potential effectiveness in supporting HIV+ patients.

Participants using Masivukeni reported better attitudes towards medication disclosure, increased social support, and improved relationships with healthcare providers, suggesting that this approach enhances the psychosocial aspects of adherence counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Lay Counselor Capacity to Improve Patient Outcomes with Multimedia Technology. Robbins, RN., Mellins, CA., Leu, CS., et al.[2022]

A pilot study involving 23 individuals living with HIV tested a videophone-based intervention to improve medication adherence, resulting in significant increases in self-reported adherence rates.

Participants found the videophone method for conducting pill counts acceptable, although challenges such as poor video quality and high equipment costs were noted, suggesting areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Videophone Technology to Address Medication Adherence Issues in Persons with HIV. Skrajner, MJ., Camp, CJ., Haberman, JL., et al.[2021]

The Masivukeni mHealth application significantly empowered lay-counsellors in Cape Town, South Africa, to deliver high-quality HIV and ART counselling during a 3-year randomized control trial.

The Department of Health expressed strong support for further studies to assess the feasibility of implementing Masivukeni on a larger scale, highlighting its potential as an effective counselling tool in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Lay-Counsellors with Technology: Masivukeni, a Standardized Multimedia Counselling Support Tool to Deliver ART Counselling. Gouse, H., Robbins, RN., Mellins, CA., et al.[2020]

Technology-driven interventions, including mobile phones and internet-based approaches, have shown significant effectiveness in improving adherence to antiretroviral therapy (ART) among individuals living with HIV, based on a review of 13 studies conducted between 2013 and 2015.

These technology-enhanced strategies not only support ART adherence but also lead to better clinical outcomes, highlighting their potential as a low-cost solution to manage the increasing demand for HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for Technology Interventions to Promote ART Adherence in Adult Populations: a Review of the Literature 2012-2015. Amico, KR.[2022]

In a study involving 425 young people living with HIV, weekly phone counseling sessions led to significant improvements in clinical outcomes, including 74% initiating antiretroviral therapy (ART) and 47% achieving viral suppression after 16 months.

Bidirectional text messaging enhanced the effectiveness of counseling by improving care engagement, suggesting that interactive communication can further support individuals in managing their HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phone-Delivered Intervention to Improve HIV Care for Young People Living With HIV: Trial to Inform Implementation and Utility. Kalichman, SC., Kalichman, MO., Eaton, LA.[2023]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-4-2023-693d2

Video-Counseling + App for HIV/AIDS Management Research shows that phone-delivered counseling and videophone interventions can improve medication adherence and health outcomes for people living with HIV.

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05877729

Intervention for Virologic Suppression in Youth The goal of this randomized clinical trial is to test the effect of a technology-based intervention with an Adaptive Treatment Strategy (ATS) among youth living ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10565330/

iVY: protocol for a randomised clinical trial to test the effect of a ... iVY is testing the effect of a technology-based mobile health app and video-counselling intervention in a randomised clinical trial (RCT) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7869821/

Video-Counseling Intervention to Address HIV Care ... The intervention consisted of twelve 20–30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1089/apc.2024.0237

Telehealth Interventions to Improve HIV Care Continuum ... Interventions that leverage telehealth technologies have the potential to improve health outcomes among people with HIV who experience multiple complex ...

6. greenlighthealth.com greenlighthealth.com/portfolio/hct/

HCT (HIV Youth to Adult Care Transition) HCT is a multilevel mHealth intervention designed to support youth living with HIV and their pediatric/adolescent and adult care providers. Principle ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949916X24000306

Digital tools for improving antiretroviral adherence among ... This review synthesized African evidence to assess the roles and impact of digital monitoring tools for improving ART adherence and retention among PLHIV in ...