Positive Peers Intervention Clinical Trial (PoPIT)

MetroHealth Medical Center

Status: Enrolling

Conditions: HIV Infections

Treatments: Other: Positive Peers mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT06388109

IRB15-00741

Details and patient eligibility

About

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 with HIV.

Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?

Participants will:

• download the mobile app onto their personal smartphone
• Use the mobile app as they find useful
• complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months.

Full description

Participants will load the Positive Peers app on their personal device (either immediately or after a 6 month delay) and be encouraged to use the app regularly. Eligible patients who decline participation in the intervention will be asked to participate in an observational arm.

All participants will complete a brief baseline survey. Participants in the immediate or delayed arms will also complete surveys at 3, 6, 9, and 12 months. Medical data will be collected from the medical record and usage data will be collected from the app itself. Medical data will be collected for 12 months prior to enrollment and 18 months after enrollment. At the end of the study, participants are welcome to continue to use the app.

Enrollment: 250 estimated patients

Sex: All

Ages: 13 to 34 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV+
• Identifies as either a racial, ethnic, sexual or gender minority

One of the following:

• Newly diagnosed within last 12 months
• Out of care (greater than 6 months between any two HIV provider visits in last 24 months)
• Not virally suppressed (any viral load > 200 copies in last 24 months)
• Has a working smartphone
• Functional English ability

Exclusion criteria

• prior use of Positive Peers mobile app

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Immediate Start

Experimental group

Description:

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

Treatment:

Other: Positive Peers mobile app

Delayed Start

Active Comparator group

Description:

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

Treatment:

Other: Positive Peers mobile app

Observational Cohort

No Intervention group

Description:

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.