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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mobile-based approach to prevent HIV among young men who have sex with men (YMSM). It aims to determine if the MyPEEPS Mobile app, combined with virtual guidance on using PrEP (a medication to prevent HIV), can increase PrEP use and reduce risky behaviors linked to HIV. Participants in one group will use the app and receive virtual support, while those in the other group will receive standard care information and app access. Ideal candidates are HIV-negative individuals assigned male at birth, aged 16-25, who have had condomless anal sex with a male in the past year and own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative HIV prevention strategies tailored for young men.

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 prior data suggests that this intervention is safe for improving HIV prevention outcomes in YMSM?

Research has shown that the MyPEEPS Mobile app is easy to use. It is designed to help young men who have sex with men (YMSM) reduce behaviors that increase the risk of HIV. No significant reports of negative effects have emerged from using this app, indicating its safety for users.

For the electronic PrEP peer navigation component, studies have demonstrated its effectiveness in helping individuals adhere to their PrEP (pre-exposure prophylaxis) plans. PrEP is a medication that can prevent HIV. No major safety concerns have been reported with this type of digital support.

Overall, both components of the MyPEEPS Mobile Plus approach appear safe based on previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MyPEEPS Mobile for HIV prevention because it offers a unique approach by integrating a mobile application with electronic peer navigation to encourage the use of PrEP (pre-exposure prophylaxis). Unlike standard care, which typically provides information and referrals, this method leverages technology and peer support to actively engage users over a 12-month period. This combination of digital tools and personalized guidance aims to improve adherence to preventive measures, potentially making it more effective in reducing HIV risk among individuals.

What evidence suggests that MyPEEPS Mobile Plus and Electronic PrEP peer navigation could be effective for HIV prevention?

Research shows that the MyPEEPS Mobile app, available to participants in this trial, effectively provides HIV prevention information for young men who have sex with men (YMSM). Studies have found that the app is easy to use and can help reduce risky behaviors, such as having unprotected sex. Users reported fewer instances of sex without a condom, lowering the risk of contracting HIV.

Participants in the intervention arm of this trial will also receive electronic PrEP (pre-exposure prophylaxis) peer support. This support has proven effective in helping people take PrEP regularly. PrEP is a medication that helps prevent HIV. Reviews have shown that digital tools like this can help users adhere to PrEP guidelines, further reducing the risk of HIV. Together, these tools aim to increase PrEP use and improve HIV prevention among high-risk groups. ^{1 2 3 5 6}

Who Is on the Research Team?

Lisa Kuhns, PhD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Robert Garofalo, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260538/

Digital HIV Pre-exposure Prophylaxis Interventions - PMC The purpose of this Community Guide systematic review was to present the characteristics and effectiveness of digital PrEP adherence interventions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05281393

PrEP2Prevent An Online PrEP Navigation and Activation ... The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005443/

eHealth-Enhanced Peer Navigation for Substance Use ... This paper describes a protocol for a pilot randomized controlled trial that aims to improve linkage to substance use treatment and HIV prevention services

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/159326

Digital HIV Pre-exposure Prophylaxis Interventions The purpose of this Community Guide systematic review was to present the characteristics and effectiveness of digital PrEP adherence interventions. Methods: The ...

5. joghr.org joghr.org/article/28347-results-from-a-peer-based-digital-systems-navigation-intervention-to-increase-hiv-prevention-and-care-behaviors-of-young-trans-women-in-rio-de-janeiro

Results from a peer-based digital systems navigation ... This study aimed to determine the efficacy of an evidence-based peer and mHealth delivered systems navigation intervention for increasing human ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S014971892100094X

Informing the future of PrEP navigation: Findings from a five ... The findings pinpoint PrEP navigation hybrid modality and having health insurance as promising strategies to increase PrEP uptake among priority groups.