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Recruiting NCT06388109

Positive Peers Intervention Clinical Trial

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive Peers mobile app.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: 13 years — 34 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Randomized Control Trial of Positive Peers mHealth App as a Clinic-based Intervention to Optimize HIV Outcomes Among Young, Minority Persons Living With HIV

Overview

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.

Detailed 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.

Interventions

  • Other Positive Peers mobile app
    Positive Peers is a multifunctional mobile app using a mind, body, spirit theme aimed to improve HIV care outcomes.

Primary outcome measures

  • Viral suppression [Time frame: 6 months]
Secondary outcome measures (3)
  • Correlates of app use and viral suppression [Time frame: 6 months]
  • Correlates of app use and retention in care [Time frame: 12 months]
  • Correlates of app use and HIV related perceived stigma [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 6 centers
  • Northeast Valley Health Corporation — Van Nuys
  • Infectious Disease Practice- Rutgers University — Newark
  • Equitas Health — Cincinnati
  • Equitas Health — Columbus
  • Thomas Street Clinic — Houston
  • UW Madison Clinic at Harborview — Seattle

Publications

  • Step MM, McMillen Smith J, Lewis SA, Avery AK. Using the Positive Peers Mobile App to Improve Clinical Outcomes for Young People With HIV: Prospective Observational Cohort Comparison. JMIR Mhealth Uhealth. 2022 Sep 28;10(9):e37868. doi: 10.2196/37868. PMID 36170001
  • Comulada WS, Step M, Fletcher JB, Tanner AE, Dowshen NL, Arayasirikul S, Keglovitz Baker K, Zuniga J, Swendeman D, Medich M, Kao UH, Northrup A, Nieto O, Brooks RA; Special Projects Of National Significance Social Media Initiative Study Group. Predictors of Internet Health Information-Seeking Behaviors Among Young Adults Living With HIV Across the United States: Longitudinal Observational Study. J PMID 33136057
  • Step MM, Knight K, McMillen Smith J, Lewis SA, Russell TJ, Avery AK. Positive Peers Mobile Application Reduces Stigma Perception Among Young People Living With HIV. Health Promot Pract. 2020 Sep;21(5):744-754. doi: 10.1177/1524839920936244. Epub 2020 Aug 6. PMID 32757838
  • Step MM, McMillen Smith J, Kratz J, Briggs J, Avery A. "Positive Peers": Function and Content Development of a Mobile App for Engaging and Retaining Young Adults in HIV Care. JMIR Form Res. 2020 Jan 30;4(1):e13495. doi: 10.2196/13495. PMID 32012035
  • Step MM, Catania LA, McMillen Smith J, Lewis SA, Bitar Y, Cheruvu VK, Berg KA, Hallam JS, Avery AK. 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. JMIR Res Protoc. 2026 Mar 17;15:e87601. doi: 10.2196/87601. PMID 41843906

Identifiers

NCT: NCT06388109 · IRB15-00741

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗