Clinical trial NCT06388109: Positive Peers Intervention Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Kent State University
First posted: 2024-04-29
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial with observational cohort for eligible patients who decline participation
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Viral suppression
timeFrame: 6 months
Secondary outcomes:
measure: Correlates of app use and viral suppression
timeFrame: 6 months
measure: Correlates of app use and retention in care
timeFrame: 12 months
measure: Correlates of app use and HIV related perceived stigma
timeFrame: 3 months
Other outcomes:
Locations:
city: Van Nuys
country: United States
facility: Northeast Valley Health Corporation
state: California
city: Newark
country: United States
facility: Infectious Disease Practice- Rutgers University
state: New Jersey
city: Cincinnati
country: United States
facility: Equitas Health
state: Ohio
city: Columbus
country: United States
facility: Equitas Health
state: Ohio
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: Seattle
country: United States
facility: UW Madison Clinic at Harborview
state: Washington
Study officials:
affiliation: MetroHealth/ CWRU
name: Ann Avery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kent State University
name: Mary Step, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.