Evaluation of the Positive Peers Mobile App 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.

BACKGROUND

People at greatest risk for poor HIV outcomes include young (13-34) people of color who have sex with men. Individuals in this population are least likely to be aware of their HIV status and are at the highest risk for disengaging from medical care and antiretroviral therapy. The Positive Peers mobile app (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 the perceived affordances of the PPA.

OBJECTIVE

This study aims to determine the optimal deployment of the PPA in clinical settings (at enrollment vs delayed start) and to compare intervention outcomes with 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 designed to evaluate the effectiveness of the PPA as a tool for use in clinical settings. Trial arms compare the immediate deployment of the PPA with usual care and observation only. This protocol outlines a mixed methods design consisting of concurrent prospective self-report questionnaires, in-depth 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, self-efficacy, substance use, and social support. Multiple aspects of PPA intervention engagement are measured natively within the app. Outcomes include HIV National Quality Forum indicators and perceived HIV-related stigma.

RESULTS

The research protocol (1R01MD019185-01) was funded for US $903,363.00 in direct costs by the National Institute for Minority Health and Health Disparities on September 24, 2023, for 5 years. The study began recruiting patients on June 3, 2024, and will continue accrual until November 27, 2026.

CONCLUSIONS

Findings will provide evidence of the usefulness of the PPA 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 app. Qualitative data will provide a phenomenological description of intervention engagement and perceived user efficacy.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06388109; https://clinicaltrials.gov/ct2/show/NCT06388109.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/87601.