Positive Peers Intervention Clinical Trial

HIV Infections Clinical Trial

— PoPIT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388109
• Other study ID #: IRB15-00741
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: MetroHealth Medical Center
• Contact: Jennifer McMillen-Smith, LISW-S
• Phone: 2167784051
• Email: jmsmith[@]metrohealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: November 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	Equitas Health	Cincinnati	Ohio
United States	Equitas Health	Columbus	Ohio
United States	Thomas Street Clinic	Houston	Texas
United States	Infectious Disease Practice- Rutgers University	Newark	New Jersey
United States	UW Madison Clinic at Harborview	Seattle	Washington
United States	Northeast Valley Health Corporation	Van Nuys	California

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Kent State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	Proportion of participants who have HIV viral load <200 copies/ ml	6 months
Secondary	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).	6 months
Secondary	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)	12 months
Secondary	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).	3 months