PositiveLinks mHealth Platform for HIV/AIDS

Recruiting at 12 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

753 Participants Needed

Trial Summary

What is the purpose of this trial?

To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.

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 data supports the effectiveness of the PositiveLinks treatment for HIV/AIDS?

Research shows that the PositiveLinks app helps people with HIV stay engaged in their care and achieve better control of the virus. Users of the app experienced improvements in care engagement and viral load suppression, which means the amount of virus in their blood decreased. ^{1 2 3 4 5}

How is the PositiveLinks treatment different from other HIV treatments?

PositiveLinks is unique because it is a mobile health app designed to support people with HIV by providing daily medication reminders, mood and stress check-ins, educational resources, and secure messaging with healthcare providers, which helps improve engagement in care and viral load suppression. ^{1 2 4 6 7}

Research Team

Amanda D Castel, MD, MPH

Principal Investigator

George Washington University

Karen Ingersoll, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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® 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]

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]

References

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

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

An mHealth Platform for People With HIV Receiving Care in Washington, District of Columbia: Qualitative Analysis of Stakeholder Feedback. [2023]

3. United States 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. [2022]

4. Canada 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. [2021]

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

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. [2019]

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

Secure Messaging Through PositiveLinks: Examination of Electronic Communication in a Clinic-Affiliated Smartphone App for Patients Living with HIV. [2022]

7. United States 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. [2018]