HIV InfectionsPoPITNCT06388109
Positive Peers Intervention Clinical Trial
A study testing Positive Peers mobile app in people with HIV Infections, run by MetroHealth Medical Center at 7 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 13 to 34 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Positive Peers mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Jun 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 34 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- prior use of Positive Peers mobile app
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ann Avery, MD contact
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
Equitas Health
Cincinnati, Ohio, 45206
Tania Slack-Peterson, TaniaSlack@equitashealth.com
Kelly Wesp, PhD
- Active, not recruiting
Equitas Health
Columbus, Ohio, 43203
- Recruiting
Thomas Street Clinic
Houston, Texas, 77004-8004
Ernesto Linares Pineda, Ernesto.LinaresPineda@bcm.edu
Shital Patel, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Megan McWain, MS, 901-595-7564, megan.mcwain@stjude.org
Megan Wilkins, PhD
- Recruiting
Infectious Disease Practice- Rutgers University
Newark, New Jersey, 07103
Sireesha Kada, sk2885@njms.rutgers.edu
Shoba Swaminathan, MD
- Recruiting
UW Madison Clinic at Harborview
Seattle, Washington, 98104
Amari Perry, amarip@uw.edu
H Nina Kim, MD, MPH
- Recruiting
Northeast Valley Health Corporation
Van Nuys, California, 91405
Noel Barragan, (818) 988-6335 ext. 50721, noelbarragan@nevhc.org
Herberth Osorio, MPH
About this study
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
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.
- Conditions
- HIV Infections
- Being tested
- Positive Peers mobile app
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Peers mobile appOther
Positive Peers is a multifunctional mobile app using a mind, body, spirit theme aimed to improve HIV care outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start | Experimental | Participants in the immediate start arm will download and begin use of the Positive Peers app at the enrollment visit. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Proportion of participants who have HIV viral load <200 copies/ ml
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 6 months
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)
Measured: 12 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start3 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial with observational cohort for eligible patients who decline participation
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kent State University
- Responsible party
- Principal investigator, Ann Avery, MetroHealth Medical Center
- Investigators
- Ann Avery, MD, Principal investigator, MetroHealth/ CWRUMary Step, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388109
- Sponsor's protocol ID
- IRB15-00741
- Acronym
- PoPIT
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36170001Comulada 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 33136057Step 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 32757838Step 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 32012035Step 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06388109
- Acronym / sponsor ID
- PoPIT / IRB15-00741
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Kent State University
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized control trial with observational cohort for eligible patients who decline participation
| Arm | Type | Receives |
|---|---|---|
| Immediate Start | Experimental | Other: Positive Peers mobile appParticipants in the immediate start arm will download and begin use of the Positive Peers app at the enrollment visit. |
| Delayed Start | Active comparator | Other: Positive Peers mobile appParticipants in the delayed start arm will download and begin use of the Positive Peers app 6 months after enrollment |
| 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. |
Who may qualify
- Ages
- 13 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- HIV+
- Identifies as either a racial, ethnic, sexual or gender minority or a cisgender female and
- 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)
Key exclusion criteria (1 listed)
- prior use of Positive Peers mobile app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Peers mobile appPositive Peers is a multifunctional mobile app using a mind, body, spirit theme aimed to improve HIV care outcomes. | Other | Delayed Start, Immediate Start |
Primary outcome
Viral suppression
Time frame: 6 months
Proportion of participants who have HIV viral load <200 copies/ ml
3 secondary outcomes
Correlates of app use and viral suppression
Time frame: 6 months
Correlates of app use and retention in care
Time frame: 12 months
Correlates of app use and HIV related perceived stigma
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 36170001Step 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.
- Background: PubMed 33136057Comulada 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.
- Background: PubMed 32757838Step 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.
- Background: PubMed 32012035Step 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.
- Derived from this study: PubMed 41843906Step 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.
- Individual participant dataSharing planned: 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Avery, MD contact
Ann Avery, MD principal investigator
MetroHealth/ CWRU
Mary Step, PhD principal investigator
Kent State University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Peers mobile app in people with HIV Infections, run by MetroHealth Medical Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer McMillen-Smith, LISW-S (2167784051, jmsmith@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388109, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.