Positive Peers Intervention Clinical Trial

NCT06388109 | Recruiting

• 1 other identifier: IRB15-00741
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Viral suppression

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

  6 months

Secondary Outcomes (3)

• Correlates of app use and viral suppression

  6 months

• Correlates of app use and retention in care

  12 months

• Correlates of app use and HIV related perceived stigma

  3 months

Study Arms (3)

Immediate Start

EXPERIMENTAL

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

Delayed Start

ACTIVE COMPARATOR

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

Observational Cohort

NO INTERVENTION

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

Positive Peers mobile app OTHER

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

Delayed Start; Immediate Start

Eligibility Criteria

• Age: 13 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• prior use of Positive Peers mobile app

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Kent State University: collaborator

Study Sites (6)

Northeast Valley Health Corporation

Van Nuys, California, 91405, United States

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

RECRUITING

Thomas Street Clinic

Houston, Texas, 77004-8004, United States

RECRUITING

UW Madison Clinic at Harborview

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 33136057 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ann Avery, MD

  MetroHealth/ CWRU

  PRINCIPAL INVESTIGATOR

• Mary Step, PhD

  Kent State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer McMillen-Smith, LISW-S

CONTACT

2167784051; jmsmith@metrohealth.org

Ann Avery, MD

CONTACT

aavery@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: co-Principal Investigator

Model Details: randomized control trial with observational cohort for eligible patients who decline participation

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 1 year after award ends
• Access Criteria: Request for data to reproduce results or for meta-analysis.

Locations

US (6)