MyPEEPS Mobile Plus for HIV Prevention

Overseen By Rebecca Schnall, PhD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: PrEP

Disqualifiers: HIV positive, Transgender identity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

500 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot participate if you are currently using PrEP consistently.

What data supports the effectiveness of the MyPEEPS Mobile Plus treatment for HIV prevention?

The MyPEEPS Mobile intervention has been adapted from an evidence-based, face-to-face HIV prevention program into a mobile app, showing promise in reducing sexual risk behaviors among young men. It has been designed to be user-friendly and effective in delivering HIV prevention information, particularly for young men who are at higher risk of HIV. ^{1 2 3 4 5}

Is MyPEEPS Mobile Plus safe for humans?

The available research on MyPEEPS Mobile Plus focuses on its development and usability for HIV prevention among young men, but it does not provide specific safety data. However, as a mobile app delivering educational content, it is generally considered safe for use. ^{1 2 3 4 5}

How is the MyPEEPS Mobile treatment unique for HIV prevention?

MyPEEPS Mobile is unique because it is a mobile app designed to deliver HIV prevention and sexual health education specifically for young men, particularly those from diverse racial and ethnic backgrounds. Unlike traditional face-to-face interventions, it provides a portable, accessible platform that empowers users with information and strategies to reduce HIV risk behaviors. ^{1 3 4 5 6}

What is the purpose of this trial?

MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

Research Team

Robert Garofalo, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Lisa Kuhns, PhD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for young men who have sex with men (YMSM), considered at high risk for HIV. Participants should be interested in using mobile technology and virtual peer support to help prevent HIV infection.

Inclusion Criteria

Understand and read English

Own a smartphone

HIV-negative (OraQuick verified)

Exclusion Criteria

HIV Positive

I am able to understand and consent to the study without being under the influence of substances.

I identify as transgender.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation

12 months

Continuous access throughout the study period

Control

Participants in the control arm will receive standard of care information and access to the MyPEEPS Mobile App

12 months

Continuous access throughout the study period

Follow-up

Participants are monitored for PrEP initiation, adherence, and persistence, and HIV risk behavior

12 months

Baseline, 6-month follow-up, 12-month follow-up

Treatment Details

Interventions

• Electronic PrEP peer navigation
• MyPEEPS Mobile

Trial Overview The study tests 'MyPEEPS Mobile Plus', a mobile intervention, combined with virtual PrEP Peer Navigation, aiming to increase use of PrEP medication and reduce risky behaviors related to HIV.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period.

Group II: Control Active Control 1 Intervention

Participants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study.

MyPEEPS Mobile is already approved in United States for the following indications:

Approved in United States as MyPEEPS Mobile for:

• HIV prevention in young men who have sex with men (YMSM)
• HIV prevention in young transgender men and transmasculine youth

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Callen-Lorde Community Health Center

Collaborator

Trials

6

Recruited

5,600+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Findings from Research

The MyPEEPS Mobile intervention is a new mobile technology-based approach aimed at delivering effective HIV prevention information specifically for young men who have sex with men (YMSM).

This study represents the first test of a scaled-up version of an existing intervention, indicating a commitment to using user feedback and expert input to enhance its design and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of MyPEEPS Mobile: A Behavioral Health Intervention for Young Men. Schnall, R., Kuhns, L., Hidalgo, M., et al.[2020]

The MyPEEPS Mobile app is considered a valuable educational tool for sexual health among transmasculine youth, highlighting its potential to promote health and reduce sexual risk.

To enhance its effectiveness, the app needs adaptations that focus on personalization, inclusivity, and specific educational content tailored to the unique experiences of transmasculine youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Study to Inform Adaptation of MyPEEPS Mobile for Transmasculine Youth. Anderson, A., Karczmar, A., Kuhns, LM., et al.[2022]

The MyPEEPS app, adapted from a group-based HIV prevention curriculum to a mobile format, was found to be highly usable and effective, with 62.5% of participants completing all modules in an average of 28.85 days during a 6-week pilot trial involving 40 young men across four cities.

Participants reported that the app improved their sexual health knowledge and awareness of risky behaviors, indicating its potential as a valuable tool for HIV prevention among young men aged 13-18.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility trial of the MyPEEPS mobile app to reduce sexual risk among young men in 4 cities. Ignacio, M., Garofalo, R., Pearson, C., et al.[2022]

The MyPEEPS Mobile app was found to be highly usable and acceptable among 20 young adult men who have sex with men (MSM) aged 19 to 25, with participants appreciating its engaging features like avatars and animations.

Participants provided constructive feedback for improvement, suggesting the need for more adult-oriented content and advanced educational materials to better meet the needs of young MSM with varying levels of sexual experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Sexual Health App on Empowerment, Education, and Prevention for Young Adult Men (MyPEEPS Mobile): Acceptability and Usability Evaluation. Gannon, B., Davis, R., Kuhns, LM., et al.[2020]

The MyPEEPS Mobile app, designed to deliver HIV prevention information to young men aged 13-24, received positive usability feedback from both experts and end users, indicating it is user-friendly and effective for its target audience.

End users rated the app's usability with a mean score of 1.63, suggesting strong acceptance, and expert evaluations identified usability issues that will be addressed before further testing in a pilot study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention for HIV Prevention Among Racially and Ethnically Diverse Young Men: Usability Evaluation. Cho, H., Powell, D., Pichon, A., et al.[2022]

The SMARTtest app, designed to support transgender women using the INSTI Multiplex® HIV/syphilis rapid test, received positive feedback for its ease of use and helpful instructions, indicating it effectively aids in self-testing and interpreting results.

Participants valued the app's feature that provided information on clinics for confirmatory testing, highlighting its potential to improve access to care for transgender women, although they suggested enhancements for better functionality and user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex. Rael, CT., Kutner, BA., Lentz, C., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Development of MyPEEPS Mobile: A Behavioral Health Intervention for Young Men. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Study to Inform Adaptation of MyPEEPS Mobile for Transmasculine Youth. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot feasibility trial of the MyPEEPS mobile app to reduce sexual risk among young men in 4 cities. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Sexual Health App on Empowerment, Education, and Prevention for Young Adult Men (MyPEEPS Mobile): Acceptability and Usability Evaluation. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention for HIV Prevention Among Racially and Ethnically Diverse Young Men: Usability Evaluation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex. [2023]