Positive Peers App for HIV

(PoPIT Trial)

Recruiting at 5 trial locations

Overseen By Herberth Osorio, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Prior use of Positive Peers

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: 7

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile app called Positive Peers can help young people with HIV manage their condition more effectively. The main goal is to determine if the app improves viral suppression, meaning it keeps the virus at very low levels. The trial will also examine how the app might assist with maintaining regular care and reducing feelings of stigma related to HIV. Suitable participants include those diagnosed with HIV in the past year, those who have experienced gaps in medical care, or those who have struggled to control the virus, and who have access to a smartphone. Participants will either begin using the app immediately, after six months, or opt to provide their health information without using the app. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance HIV management for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Positive Peers app is safe for young persons with HIV?

Research shows that the Positive Peers app is safe for users and supports young people living with HIV. No reports of negative effects have emerged from using the app. It provides a private, stigma-free space for users to connect with others who share similar experiences, offering encouragement and support. The app aims to improve health outcomes, making it a useful tool for managing HIV. For those considering joining a trial involving this app, the safety evidence suggests it is well-tolerated and focused on providing positive support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Peers app because it represents a novel approach to supporting individuals with HIV. Unlike traditional treatment options that focus on antiretroviral therapy to manage the virus itself, Positive Peers offers a digital platform designed to enhance social support and engagement among users. This app creates a virtual community where users can connect with peers, access resources, and share experiences, potentially improving mental health and overall well-being. By addressing the social and emotional aspects of living with HIV, Positive Peers could complement existing medical treatments and improve quality of life for those affected by the condition.

What evidence suggests that the Positive Peers app is effective for improving viral suppression in young persons with HIV?

This trial will evaluate the Positive Peers app. Participants in the "Immediate Start" arm will begin using it at the enrollment visit, while those in the "Delayed Start" arm will start six months after enrollment. Studies have shown that young people who used the Positive Peers app were 4.2 times more likely to keep their HIV under control compared to those who did not use the app. The app provides a supportive community where users can connect with others who have similar experiences, offering encouragement and advice. This sense of community and support can help users stick to their treatment plans. Research indicates that feeling connected and supported can also reduce the stigma associated with HIV and improve ongoing care. Together, these factors make the Positive Peers app a promising tool to help young people with HIV manage their health better. ^{1 3 4 6 7}

Who Is on the Research Team?

Ann Avery, MD

Principal Investigator

MetroHealth/ CWRU

Mary Step, PhD

Principal Investigator

Kent State University

Are You a Good Fit for This Trial?

This trial is for young people aged 13-34 with HIV, particularly from minority groups. Participants need to have a personal smartphone to download and use the Positive Peers mobile app and be willing to complete online surveys over a year at specified intervals.

Inclusion Criteria

HIV+

I identify as part of a minority group.

One of the following: Newly diagnosed within the last 12 months, Out of care (Not seen in the last 12 months), Not virally suppressed (viral load > 200 copies in the last 12 months), Has a working smartphone, Functional English ability

Exclusion Criteria

Prior use of Positive Peers mobile app

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline

Participants complete a baseline survey and download the Positive Peers app

1 week

1 visit (in-person or virtual)

Immediate Start Intervention

Participants in the immediate start arm begin using the Positive Peers app

12 months

Online surveys at 3, 6, 9, and 12 months

Delayed Start Intervention

Participants in the delayed start arm begin using the Positive Peers app after a 6-month delay

12 months

Online surveys at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for viral suppression and retention in care

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Positive Peers

Trial Overview The study is testing whether the Positive Peers mobile app can help increase rates of viral suppression in participants. It also aims to identify user characteristics linked with better health outcomes, retention in care, and reduced perceived stigma related to HIV.

How Is the Trial Designed?

Group I: Immediate Start Experimental Treatment 1 Intervention

Participants in the immediate start arm will download and begin use of the Positive Peers app at the enrollment visit.

Group II: Observational Cohort Active Control 1 Intervention

Participants in the observational cohort have declined participation in the clinical trial but agree to do the baseline survey and have medical outcomes data recorded.

Group III: Delayed Start Active Control 1 Intervention

Participants in the delayed start arm will download and begin use of the Positive Peers app 6 months after enrollment

Positive Peers is already approved in United States for the following indications:

Approved in United States as Positive Peers for:

• Support for HIV care and management among young adults (13-34 years old)

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Kent State University

Collaborator

Trials

46

Recruited

6,900+

Published Research Related to This Trial

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]

A study involving 83 patients living with HIV showed that different usage patterns of the PositiveLinks app correlated with viral suppression outcomes, with users categorized into four distinct classes based on their engagement levels.

Maximizers, who frequently used all app features, maintained high viral suppression rates over 12 months, while the As-Needed Communicators, who used the app minimally, experienced a decline in viral suppression, highlighting the importance of consistent app engagement for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward understanding the impact of mHealth features for people with HIV: a latent class analysis of PositiveLinks usage. Canan, CE., Flickinger, TE., Waselewski, M., et al.[2022]

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 Positive Peers App (PPA) significantly improved HIV care outcomes for younger users (ages 13-24), with users being 2.85 times more likely to obtain necessary HIV lab tests and 4.2 times more likely to achieve sustained viral suppression compared to nonusers.

This pilot study, involving 259 participants, suggests that the PPA is a valuable tool for engaging young people in HIV care, and it is being adopted in other areas to help combat the HIV epidemic, although further validation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Positive Peers Mobile App to Improve Clinical Outcomes for Young People With HIV: Prospective Observational Cohort Comparison. Step, MM., McMillen Smith, J., Lewis, SA., et al.[2023]

In a study of 87 participants with HIV, older members (≥50 years) used the PositiveLinks app significantly more than younger members (<50 years), with higher app launches and Community Message Board (CMB) posts at both 6 and 12 months.

Older participants not only engaged more with the app but also provided more social support through their posts, suggesting that mobile health interventions can effectively foster social connections among older adults living with chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Mobile Health Intervention by Older Versus Younger People with HIV: Analysis of Usage, Social Support, and Network Interactions. Flickinger, TE., Campbell, BR., Timm, A., et al.[2023]

The Positive Links smartphone app facilitated social support among 55 participants living with HIV over 8 months, with 52% of analyzed posts providing support, primarily emotional in nature.

Participants reported feeling a sense of connection and support through the app, although some faced technical issues that hindered their full engagement, highlighting the app's potential to improve care for those unable to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support in a Virtual Community: Analysis of a Clinic-Affiliated Online Support Group for Persons Living with HIV/AIDS. Flickinger, TE., DeBolt, C., Waldman, AL., et al.[2018]

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]

In a one-month pilot study involving 97 patients with HIV, the Positive Health Check (PHC) web-based intervention was well-received, with 70.1% of users completing it in an average of 15 minutes.

The intervention effectively engaged patients, with 77.7% selecting behavioral tips and 48.2% making commitments to discuss health questions with their providers, indicating its potential to support HIV care and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Health Check intervention tool usage during a feasibility pilot in HIV primary care clinics. Galindo, CA., Freeman, A., Abdallah, I., et al.[2023]

The Positive Peers smartphone application effectively creates a supportive virtual community for young people living with HIV, helping to reduce perceived stigma over time, particularly among different ethnic groups.

Participants reported that the app fostered a sense of belonging and improved self-image, suggesting that mobile health applications can play a crucial role in managing the psychosocial aspects of living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Peers Mobile Application Reduces Stigma Perception Among Young People Living With HIV. Step, MM., Knight, K., McMillen Smith, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9557764/

Using the Positive Peers Mobile App to Improve Clinical ... The Positive Peers App (PPA) is a multifunctional HIV support tool designed to improve HIV-related clinical outcomes for young people with HIV.

2. mhealth.jmir.org mhealth.jmir.org/2022/9/e37868

Using the Positive Peers Mobile App to Improve Clinical ... The Positive Peers App (PPA) is a multifunctional HIV support tool designed to improve HIV-related clinical outcomes for young people with HIV.

3. targethiv.org targethiv.org/sites/default/files/media/documents/2023-04/IHIP_PositivePeers_FactSheet_FINAL508.pdf

Positive Peers Fact Sheet Those who participated in the intervention were 4.2 times more likely to reach sustained viral suppression than those who did not enroll in Positive. Peers.

4. positivepeers.org positivepeers.org/

Positive Peers: A private app for young people living with HIV Connect 24/7 to young people with similar experiences and concerns, providing each other with encouragement, comfort, and advice.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08042-8

Peers plus mobile app for treatment in HIV (PATH): protocol ... Effectiveness of a peer navigation intervention to sustain viral suppression among HIV-positive men and transgender women released from jail ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06388109

Study Details | NCT06388109 | Positive Peers Intervention ... The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7055772/

“Positive Peers”: Function and Content Development of a ... “Positive Peers” is a Web-based, mobile app that serves as a tool for young adults diagnosed with HIV to manage their health, establish ...