PositiveLinks mHealth Platform for HIV/AIDS

No longer recruiting at 25 trial locations

Overseen By Jose Bordon, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Age below 16, 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: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called PositiveLinks, designed to help people with HIV stay in care and manage the virus. Researchers are conducting the trial in Washington, DC, to determine if the app can improve health outcomes for those struggling to maintain HIV care. The trial compares the app to the usual care provided at clinics. Ideal candidates for this study are people living with HIV in the DC area who have experienced challenges such as gaps in care or detectable virus levels. As an unphased trial, this study allows participants to contribute to innovative solutions that may enhance HIV care and support.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current HIV treatment while participating, as the trial focuses on using a mobile health platform to improve care.

What prior data suggests that the PositiveLinks mHealth platform is safe for persons with HIV?

Research shows that mobile health tools, like PositiveLinks, are generally easy to use. In past studies, these tools have produced good results in helping people with HIV improve their health. For example, one study found that similar apps helped users take better care of themselves and feel healthier after just four weeks.

PositiveLinks includes features like daily health check-ins, secure messaging, and support from others, all designed to help people with HIV follow their treatment plans. Although this trial doesn't focus on traditional medical safety, the technology has been used elsewhere without major safety issues.

Testing PositiveLinks in a large study indicates it has already passed initial safety checks and is considered safe enough for further testing. If considering joining the trial, this information might boost confidence in the technology's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PositiveLinks mHealth platform is unique because it leverages technology to enhance the management of HIV/AIDS. Unlike traditional treatments that focus solely on medication adherence and clinic visits, PositiveLinks provides a comprehensive digital support system through a smartphone app and a provider portal. This platform offers continuous engagement and personalized support, which could lead to improved patient retention and adherence to treatment plans. Researchers are excited about this approach because it represents a shift towards integrating digital health tools in managing chronic conditions, potentially offering a more flexible and accessible option for patients.

What evidence suggests that the PositiveLinks mHealth platform is effective for improving retention in care and viral suppression among persons with HIV?

Research has shown that the PositiveLinks mobile health platform helps people with HIV improve their care and health outcomes. In this trial, participants in the PositiveLinks arm will use the platform, which studies have demonstrated helps participants keep up with medical appointments and reduce the virus to very low levels in their blood. App users also reported feeling more socially supported and experiencing less stigma. These benefits suggest that PositiveLinks can effectively help people with HIV manage their condition. The HIV Medicine Association recommends the platform for improving HIV care and reducing the virus in the blood. ^{6 7 8 9 10}

Who Is on the Research Team?

Amanda D Castel, MD, MPH

Principal Investigator

George Washington University

Karen Ingersoll, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for people living with HIV in the DC area who can consent to participate, are at least 16 years old, and plan to stay local for the next year. Participants should speak English or Spanish at a basic level and be poorly retained in HIV care, which could mean having detectable virus levels or inconsistent clinic visits.

Inclusion Criteria

Can provide informed consent; if a minor, is in charge of own HIV care

Speaks and reads English or Spanish at 4th grade level or above

Plans to reside in the DC metro area for the next 12 months

Exclusion Criteria

I cannot legally consent to participate on my own.

I am under 16, or if 16-17, my parent manages my HIV care.

PLWH receiving care at two DC Cohort sites (~10%) will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Research

Conduct mixed methods research to assess feasibility, acceptability, and usability of PositiveLinks among the urban cohort

2 months

Focus groups and interviews

Beta Testing

Participants engage in beta testing of the PositiveLinks app, including virtual training and app usage monitoring

1 month

Virtual training session

Treatment

Participants use the PositiveLinks app or receive usual care for 12 months

12 months

Baseline, 6 months, and 12 months assessments

Follow-up

Participants are monitored for viral suppression and retention in care after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PositiveLinks

Trial Overview

The PositiveLinks mobile health platform is being tested. It's designed to help people with HIV stay on track with their treatment by offering medication reminders, mood tracking, secure messaging with healthcare staff, peer support forums, and resources for managing their condition.

How Is the Trial Designed?

Group I: PositiveLinks Experimental Treatment 1 Intervention

Participants from clinics randomized to PL will get the patient smartphone app; clinic staff will receive the provider portal and provider smartphone app, the provider online LMS (learning management system), and the research assistant will use the administrative website to enroll participants. Patients randomized to PL will use it for 12 months or more; they can opt to use it as long as it is available during the study(access depending on enrollment date).

Group II: Usual Care Active Control 1 Intervention

Participants from clinics randomized to Usual Care (UC) will receive usual clinic retention and medication adherence support services for 12M. Based on site assessments, and descriptions from the clinics, the UC condition ranges from having no ancillary support to only case management, to Ryan White funding and comprehensive services (adherence support, patient navigation, mental health, substance abuse, dental services and food banks)

PositiveLinks is already approved in United States for the following indications:

Approved in United States as PositiveLinks for:

• Improving retention in care and viral suppression among persons with HIV

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The PositiveLinks mobile app, designed to support people with HIV, was tailored based on feedback from 28 providers and 32 patients in Washington, DC, focusing on features like medication reminders and peer support to improve care retention and viral suppression.

Key benefits identified for patients included enhanced health knowledge and peer connection, while providers emphasized improved communication and self-monitoring, setting the stage for a randomized controlled trial to test the app's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An mHealth Platform for People With HIV Receiving Care in Washington, District of Columbia: Qualitative Analysis of Stakeholder Feedback. Caldwell, S., Flickinger, T., Hodges, J., et al.[2023]

A bi-directional mHealth intervention using SMS, WhatsApp, and Facebook messages effectively supported 40 newly diagnosed men who have sex with men (MSM) in Lima, Peru, during their initial 12 weeks of HIV care, facilitating better engagement and retention in treatment.

Participants frequently communicated about mental health symptoms and sought support, highlighting the importance of addressing emotional well-being alongside medical care in the HIV care continuum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Experiences of Newly Diagnosed Men Who Have Sex with Men Entering the HIV Care Cascade in Lima, Peru, 2015-2016: A Qualitative Analysis of Counselor-Participant Text Message Exchanges. Bayona, E., Menacho, L., Segura, ER., et al.[2018]

The PositiveLinks® app facilitates communication between patients living with HIV and their healthcare team, with 1,474 messages analyzed showing that 61% were received by patients, indicating strong engagement.

The messaging system effectively addresses both medical (34.3%) and social needs (12.4%), with a significant portion (87.3%) focused on information exchange, suggesting it enhances patient-centered care and strengthens patient-provider relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secure Messaging Through PositiveLinks: Examination of Electronic Communication in a Clinic-Affiliated Smartphone App for Patients Living with HIV. Flickinger, TE., Ingersoll, K., Swoger, S., et al.[2022]

The PositiveLinks (PL) mHealth app has shown promise in improving care engagement and viral load suppression among people with HIV, indicating its potential effectiveness as a supportive tool in chronic disease management.

An interim analysis of implementation at four Ryan White HIV clinics identified key facilitators, such as the app's alignment with clinic needs and effective training resources, as well as barriers like Wi-Fi access and patient privacy concerns, which will help optimize future implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. Cohn, WF., Canan, CE., Knight, S., et al.[2021]

The PositiveLinks mobile health intervention significantly improved retention in care for People Living with HIV, increasing from 51% at baseline to 88% at 6 months and 81% at 12 months, indicating its effectiveness in keeping patients engaged with their healthcare.

Participants also experienced notable clinical improvements, with viral load suppression rising from 47% at baseline to 87% at 6 months, and mean CD4 counts increasing significantly, demonstrating the intervention's potential to enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. Dillingham, R., Ingersoll, K., Flickinger, TE., et al.[2019]

The PositiveLinks (PL) smartphone platform significantly improved engagement in care and HIV viral suppression among 127 participants over a 24-month period, with notable improvements seen as early as 6 months.

Patients who used PL more frequently were over twice as likely to achieve viral suppression and 1.5 times more likely to engage in care compared to those with lower usage, highlighting the effectiveness of mobile technology in managing HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. Canan, CE., Waselewski, ME., Waldman, ALD., et al.[2020]

During the early COVID-19 pandemic, the use of secure in-app messaging between patients living with HIV and their healthcare providers significantly increased, highlighting the importance of communication in maintaining care during crises.

Qualitative analysis revealed that over half of the messages exchanged focused on medical topics, with a notable portion addressing social issues, indicating that patients and providers were actively coordinating care and building rapport during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PositiveLinks and the COVID-19 Response: Importance of Low-Barrier Messaging for PLWH in Non-urban Virginia in a Crisis. Campbell, BR., Swoger, S., Tabackman, A., et al.[2022]

Citations

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Providing 2 Types of mHealth Interventions to Support Self ...

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withpower.com

withpower.com/trial/phase-hiv-infections-4-2024-a3199?condition=hiv&overallStatus=Recruiting&hasNoPlacebo=false

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withpower.com

withpower.com/clinical-trials/for-hiv-aids?page=3

Top HIV/AIDS Clinical Trials | Power

Power is an online platform that helps thousands of HIV/AIDS patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical ...

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go.drugbank.com/conditions/DBCOND0061098

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