MyPEEPS Mobile for HIV Prevention

Recruiting at 1 trial location

Overseen By Rebecca Schnall, PhD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Transgender

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: Unknown

2500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

The MyPEEPS Mobile app is based on an evidence-driven HIV prevention program that was originally delivered face-to-face and has been adapted for mobile use. It has been tested for usability and feasibility among young men, showing promise in reducing sexual risk behaviors. ^{1 2 3 4 5}

How is the MyPEEPS Mobile treatment different from other HIV prevention treatments?

MyPEEPS Mobile is unique because it delivers HIV prevention information through a mobile app specifically designed for young men, making it accessible and engaging for a diverse group of young men who have sex with men. Unlike traditional face-to-face interventions, this app provides a personalized and private way to learn about HIV prevention, tailored to the needs and preferences of young users. ^{1 4 5 6 7}

What is the purpose of this trial?

This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=2,500), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

Research Team

Rebecca Schnall, PhD, MPH

Principal Investigator

Columbia University

Robert Garofalo, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Dustin Duncan, ScD

Principal Investigator

Columbia University

Eligibility Criteria

The MyPEEPS LITE Trial is for young men and non-binary individuals assigned male at birth, aged 16-29, who are at high risk for HIV. Participants should be sexually active with other men and can have either a suppressed or unsuppressed HIV status.

Inclusion Criteria

Understand and read English

Live within US and its territories

Own or have access to a smartphone

Exclusion Criteria

I identify as transgender.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants randomized to the intervention arm will have access to MyPEEPS Mobile for 6 months, a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities.

6 months

Control

Participants randomized to the control arm will receive standard of care, including HIV home testing every 6 months, information on sexual behaviors, and referrals for PrEP and STD testing.

6 months

Follow-up

Participants are monitored for HIV incidence and sexual risk behaviors at 6 and 12 months using OraQuick In-Home HIV Tests and the AIDS-Risk Behavior Assessment.

12 months

Treatment Details

Interventions

• MyPEEPS Mobile

Trial Overview This trial tests the MyPEEPS Mobile intervention's effectiveness in reducing new HIV infections compared to standard care. It involves using targeted ads and messages to engage participants in prevention strategies.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos).

Group II: Control Active Control 1 Intervention

Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, 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.

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+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

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]

A review of 24 mobile health interventions tailored for transgender and gender-expansive (TGE) youth found that many incorporate gender-affirming features and focus on HIV prevention, highlighting the importance of these technologies in addressing health disparities.

While many interventions show promise in providing medical and psychological gender affirmation, most have not undergone rigorous evaluation through randomized controlled trials, indicating a need for more evidence-based approaches in TGE-responsive mHealth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth for transgender and gender-expansive youth: harnessing gender-affirmative cross-disciplinary innovations to advance HIV prevention and care interventions. Skeen, SJ., Cain, D., Gamarel, KE., et al.[2023]

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, 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 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]

A mobile application was developed to adapt the MyPEEPS intervention for HIV prevention specifically for very young men who have sex with men (YMSM) aged 13-18, addressing a significant gap in evidence-based interventions for this high-risk group.

The development process involved input from an expert panel and in-depth interviews with 40 YMSM, ensuring that the app's content was relevant, engaging, and sensitive to the needs of the target age group while maintaining the integrity of the original intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of a Group-Based HIV RISK Reduction Intervention to a Mobile App for Young Sexual Minority Men. Schnall, R., Kuhns, LM., Hidalgo, MA., et al.[2022]

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. China pubmed.ncbi.nlm.nih.gov

mHealth for transgender and gender-expansive youth: harnessing gender-affirmative cross-disciplinary innovations to advance HIV prevention and care interventions. [2023]

4. 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]

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. 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]

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

Adaptation of a Group-Based HIV RISK Reduction Intervention to a Mobile App for Young Sexual Minority Men. [2022]