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RecruitingNCT06388109PoPITUpdated Aug 18, 2026

Positive Peers Intervention Clinical Trial

An interventional study of Positive Peers mobile app in HIV Infections, sponsored by MetroHealth Medical Center. Recruiting at 7 sites in United States. Open to participants aged 13 Years to 34 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
13 Years to 34 Years
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • HIV Infections

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03

Who can participate

Ages eligible
13 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

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

Exclusion Criteria:

  • prior use of Positive Peers mobile app
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Immediate Start

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

    Other: Positive Peers mobile app

  • Active comparator
    Delayed Start

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

    Other: Positive Peers mobile app

  • No intervention
    Observational Cohort

    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.

Interventions

  • OtherPositive Peers mobile app

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

05

What researchers measure

Primary outcomes

  1. Viral suppression

    Proportion of participants who have HIV viral load \<200 copies/ ml

    Time frame: 6 months

Secondary outcomes

  1. Correlates of app use and viral suppression

    Identify participant demographic and psychosocial factors from the baseline survey that correlate with app use and viral suppression (viral load \< 200 copies/ ml).

    Time frame: 6 months

  2. Correlates of app use and retention in care

    Identify participant demographic and psychosocial factors from the baseline survey that correlate with app use on retention in care (completing office visit at least every 6 months)

    Time frame: 12 months

  3. Correlates of app use and HIV related perceived stigma

    Identify participant demographic and psychosocial factors from the baseline survey that correlate with app use and changes in HIV-related perceived stigma on the HIV Stigma scale (Eriksson).

    Time frame: 3 months

06

Study locations

6 of 7 sites recruiting
  • Northeast Valley Health Corporation
    Van Nuys, California 91405, United States
    • Noel Barragan · Contact · noelbarragan@nevhc.org · (818) 988-6335
    • Herberth Osorio, MPH · Principal investigator
    Recruiting
  • Infectious Disease Practice- Rutgers University
    Newark, New Jersey 07103, United States
    Recruiting
  • Equitas Health
    Cincinnati, Ohio 45206, United States
    Recruiting
  • Equitas Health
    Columbus, Ohio 43203, United States
    Active, not recruiting
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    Recruiting
  • Thomas Street Clinic
    Houston, Texas 77004-8004, United States
    Recruiting
  • UW Madison Clinic at Harborview
    Seattle, Washington 98104, United States
    • Amari Perry · Contact · amarip@uw.edu
    • H Nina Kim, MD, MPH · Principal investigator
    • Raaka Kumbhakar, MD · Sub investigator
    Recruiting
07

References and documents

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. PubMed 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 Med Internet Res. 2020 Nov 2;22(11):e18309. doi: 10.2196/18309. PubMed 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. PubMed 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. PubMed 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. PubMed 41843906 ↗

Individual participant data

Plan to share: Yes — Participant survey data, backend usage data and medical record data will be deidentified and made available to researchers with a reasonable request and plan for use.

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT06388109
Lead sponsor
MetroHealth Medical Center
Collaborators
Kent State University
Responsible party
Ann Avery (co-Principal Investigator, MetroHealth Medical Center) — Principal investigator
First posted
Apr 29, 2024
Start date
Jun 3, 2024
Primary completion
May 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Jennifer McMillen-Smith, LISW-S
Contact
jmsmith@metrohealth.org
2167784051
Ann Avery, MD
Contact
aavery@metrohealth.org
Ann Avery, MD
principal investigator · MetroHealth/ CWRU
Mary Step, PhD
principal investigator · Kent State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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