Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 11, 2025
Open Peer Review Period: Nov 13, 2025 - Dec 16, 2025
Date Accepted: Dec 24, 2025
(closed for review but you can still tweet)
Evaluation of the Positive Peers mobile application for supporting the viral suppression of young people with HIV: Protocol for a concurrent mixed-methods evaluation with randomized controlled clinical trial and observational cohort
ABSTRACT
Background:
People most at risk for poor HIV outcomes include young (13-34) people of color who have sex with men. People in this population group are least likely to be aware of their HIV status and most at risk for disengaging with medical care and antiretroviral therapy. The Positive Peers mobile application (PPA) was designed to engage this population with real time social support, HIV and healthy lifestyle information, and medical management tools. We expect that greater PPA engagement will predict key HIV care outcomes. Study predictions are grounded in a user-centric model of digital media use and perceived affordances of the PPA.
Objective:
The purpose of the study is to determine optimum deployment of the PPA in clinical settings (at enrollment vs. delayed start), and compare intervention outcomes to a no intervention, observation only condition. The PPA is designed specifically for key HIV disparity populations, including younger, sexual, gender, racial and ethnic minorities.
Methods:
The Positive Peers Intervention Trial (PoPIT) is a multisite, randomized clinical trial to evaluate the effectiveness of the PPA as a tool for use in clinical settings. Trial arms compare immediate deployment of PPA to usual care and observation only. This protocol outlines a mixed-methods design consisting of concurrent prospective self-report questionnaires, intensive interviews with PPA users, and medical record review. PoPIT questionnaires include measures of social determinants of health, HIV related stigma, perceptions of digital media use, efficacy, substance use and social support. Multiple aspects of PPA intervention engagement are measured natively by the app. Outcomes include HIV National Quality Forum indicators and perceived HIV related stigma.
Results:
The study was funded by the National Institute for Minority Health and Health Disparities (1R01MD019185-01) in September 2023 and approved by the MetroHealth System Institutional Review Board on October 26, 2023. The study began recruiting patients on June 3rd, 2024, and will continue accrual until August 2026. Power analysis estimated sample sizes of 106 in the intervention group and 106 in the control group to achieve 90% power to detect a difference between the group proportions of 0.20. Given this estimation, we aim to recruit and randomize 250 eligible people from six clinic sites over 24 months, allowing for potential loss to follow-up. Full results are expected in the first quarter of 2027.
Conclusions:
Findings will provide evidence of the usefulness of the Positive Peers mobile app as a support tool in HIV clinical care. Primary results will inform optimization of PPA deployment and evaluate a theoretical model of user engagement with a mobile health management application. Qualitative data will provide a phenomenological description of intervention engagement and user efficacy. Clinical Trial: ClinicalTrials.gov NCT06388109
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