Positive Peers Intervention Clinical Trial (PoPIT)

April 24, 2024 updated by: Ann Avery, MetroHealth Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Van Nuys, California, United States, 91405
        • Northeast Valley Health Corporation
        • Contact:
        • Principal Investigator:
          • Herberth Osorio, MPH
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Infectious Disease Practice- Rutgers University
        • Contact:
        • Principal Investigator:
          • Shoba Swaminathan, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45206
      • Columbus, Ohio, United States, 43203
    • Texas
      • Houston, Texas, United States, 77004-8004
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Madison Clinic at Harborview
        • Contact:
        • Principal Investigator:
          • H Nina Kim, MD, MPH
        • Sub-Investigator:
          • Raaka Kumbhakar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 (Not seen in last 12 months)
  • Not virally suppressed (viral load > 200 copies in last 12 months)
  • Has a working smartphone
  • Functional English ability

Exclusion Criteria:

  • prior use of Positive Peers mobile app

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Positive Peers is a multifunctional mobile app using a mind, body, spirit theme aimed to improve HIV care outcomes.
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
Positive Peers is a multifunctional mobile app using a mind, body, spirit theme aimed to improve HIV care outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral suppression
Time Frame: 6 months
Proportion of participants who have HIV viral load <200 copies/ ml
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlates of app use and viral suppression
Time Frame: 6 months
Identify participant demographic and psychosocial factors from the baseline survey that correlate with app use and viral suppression (viral load < 200 copies/ ml).
6 months
Correlates of app use and retention in care
Time Frame: 12 months
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)
12 months
Correlates of app use and HIV related perceived stigma
Time Frame: 3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Kent State University

Investigators

  • Principal Investigator: Ann Avery, MD, MetroHealth/ CWRU
  • Principal Investigator: Mary Step, PhD, Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

within 1 year after award ends

IPD Sharing Access Criteria

Request for data to reproduce results or for meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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