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

Trial Summary

What is the purpose of this trial?

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 with HIV (YLWH) (18-29 years old). This piloted and protocolized intervention combines: (1) brief weekly sessions with a counselor via a video-chat platform (video-counseling) to discuss mental health (MH), substance use (SU), HIV care engagement, and other barriers to care; and (2) a mobile health application (app) to address barriers such as ART forgetfulness and social isolation. Individuals who are not virologically suppressed will be randomized to video-counseling+app or standard of care (SOC). Through this study, the investigators will be able to: Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH.The investigators will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT. Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. The investigators will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT. Aim 3: Explore an ATS to individualize the intervention by assigning the: 1. virologic "non-responders" in the intervention arm to intensified video-counseling+app for 16 more weeks, 2. virologic "responders" in the intervention arm to continue only app use for 16 more weeks. Researchers will compare the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need to see if delivery of care is enhanced and impact on virologic suppression.

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 data supports the effectiveness of the treatment 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. Multimedia technology has also been effective in enhancing adherence counseling, leading to better patient attitudes and support. These findings suggest that combining video-counseling with a mobile app could be beneficial for managing HIV/AIDS. ^{1 2 3 4 5}

Is the Video-Counseling + App for HIV/AIDS Management safe for humans?

The studies suggest that video-counseling and app-based interventions for HIV management are generally well-received and safe, with participants showing improved medication adherence and positive attitudes towards treatment. No significant safety concerns were reported in the trials. ^{1 3 4 5 6}

What makes the Video-Counseling + App treatment for HIV/AIDS unique?

The Video-Counseling + App treatment is unique because it combines video-counseling with a mobile health application to provide personalized support for managing HIV/AIDS. This technology-based approach allows for adaptive treatment strategies, offering interactive and standardized counseling that can be more accessible and less intimidating than traditional face-to-face counseling, especially in resource-limited settings. ^{3 6 7 8 9}

Research Team

Parya Sabari, PharmD

Principal Investigator

UCSF School of Medicine, Division of Prevention Science

Eligibility Criteria

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

I am HIV positive.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

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

Enhancing Lay Counselor Capacity to Improve Patient Outcomes with Multimedia Technology. [2022]

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

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

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

Phone-Delivered Intervention to Improve HIV Care for Young People Living With HIV: Trial to Inform Implementation and Utility. [2023]

4. 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]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Use of Videophone Technology to Address Medication Adherence Issues in Persons with HIV. [2021]

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

Empowering Lay-Counsellors with Technology: Masivukeni, a Standardized Multimedia Counselling Support Tool to Deliver ART Counselling. [2020]

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

CARE+ user study: usability and attitudes towards a tablet pc computer counseling tool for HIV+ men and women. [2018]

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

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

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

Masivukeni: development of a multimedia based antiretroviral therapy adherence intervention for counselors and patients in South Africa. [2021]