Health-E You App for Adolescent Sexual and Reproductive Health

Overseen By Arik V Marcell, MD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Age, Language, Consent, Communication, Activity, Others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Health-E You, designed to help young men discuss sexual and reproductive health with their doctors. It aims to evaluate the app's effectiveness in improving these conversations in clinical settings. The trial includes two groups: one receives usual care, and the other uses the app before doctor visits. Young men aged 13 to 21, who have had vaginal or anal sex in the past year and speak English or Spanish, may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance doctor-patient communication.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the Health-E You app is safe for adolescent males?

Research has shown that the Health-E You app is safe for teenagers. This app assists young people in discussing sexual and reproductive health with their doctors without involving medication or medical procedures.

Studies have found that the app delivers information in an easy-to-understand manner, helping users learn about important topics before visiting their doctor. No reports of negative effects from using the app suggest it is well-received.

Since the app operates on a mobile device and doesn't involve direct medical treatment, it is considered very low risk. Users simply answer questions and receive advice on what to discuss with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health-E You app because it offers a fresh approach to adolescent sexual and reproductive health by leveraging technology. Unlike traditional methods that rely on in-person counseling or pamphlets, this app provides personalized health recommendations through a digital platform, making it more accessible and engaging for teens. By tailoring content based on initial user input, the app encourages meaningful conversations with healthcare providers, potentially leading to better health outcomes. This innovative delivery method makes it easier for adolescents to access critical information anytime, anywhere, breaking down barriers that often exist with conventional care options.

What evidence suggests that the Health-E You app is effective for adolescent sexual and reproductive health?

Research shows that the Health-E You app, which participants in the intervention group of this trial will use, helps teenage boys communicate more effectively with their doctors about sexual and reproductive health. Earlier studies found the app practical, well-received, and easy for teens to use in clinics. It prepares young people to discuss important topics like birth control before seeing their doctor. This preparation can lead to better health choices and outcomes. The app has also been successfully used in schools to educate teens about birth control options. Overall, early findings suggest it could be a valuable tool for enhancing health care conversations and decision-making among teenage boys. ^{3 5 6 7 8}

Who Is on the Research Team?

Arik V Marcell, MD, MPH

Principal Investigator

Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

Are You a Good Fit for This Trial?

This trial is for male adolescents focusing on sexual and reproductive health, including prevention of sexually transmitted infections. Participants should be comfortable using a mobile app to discuss these topics with their clinicians.

Inclusion Criteria

I prefer to communicate in English or Spanish.

I have had vaginal or anal sex in the last year.

Access to phone or internet for follow-up study activities

Exclusion Criteria

My primary language is not English or Spanish.

I have not had vaginal or anal sex in the last year.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Pre-visit App Completion

Participants complete the Health-E You app prior to their clinic visit

10-15 minutes

1 session (virtual)

Clinic Visit

Participants attend a clinic visit where the app's recommendations are discussed with the clinician

1 day

1 visit (in-person)

Immediate Follow-up

Participants complete an immediate follow-up assessment 24 hours after the clinic visit

1 day

1 session (virtual)

2-Month Follow-up

Participants are monitored for changes in sexual and reproductive health behaviors and knowledge

2 months

1 session (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Health-E You app

Trial Overview

The study tests the Health-E You/Salud ìTu™ app's effectiveness in supporting discussions about sexual and reproductive health between young males and their doctors, using a stepped wedge cluster randomized controlled trial design.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

When clinics are in the intervention condition, all patients presenting for any reason will get a study weblink 24 hours before the visit; walk-ins will get a study link code in clinic. If the participants agree to participate and meet study criteria, the participants will get a survey link and then Health-E You content to complete before the visit. Previously enrolled males will not be enrolled again to maintain the research study's integrity. Thus, participants will only have one opportunity for administration to the Health-E You app. Participants will be considered to have completed the Health-E You app if the participants answer all of the app's initial tailoring questions and receive recommendations for SRH topics to discuss with the clinician. As a technology-based intervention, no direct interactions with interventionists with participants are required.

Group II: Control Group Active Control 1 Intervention

When clinics are in the control condition, patients will receive usual care. Before the visit eligible participants will receive a weblink to study information, and if agree to participate, the survey. The participants will not be presented Health-E You content and clinicians will not receive output to prime the visit; the participants will receive usual care as typical. Previously enrolled control males will not be enrolled during intervention periods to maintain the research study's integrity.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A mobile health app designed to promote safe sex and increase condom use among youth was developed based on direct input from 17 young participants (15 individual interviews and 2 focus groups) in Stockholm, emphasizing the importance of youth engagement in intervention design.

The app's content includes sex education, practical condom usage tips, and supportive messaging, with various delivery modes suggested by youth, such as text messages and videos, highlighting the need for engaging and relatable educational tools to effectively promote safe sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. Nielsen, A., Bågenholm, A., De Costa, A.[2020]

Citations

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Over 80% of adolescent pregnancies are unintended. • Significant disparities remain based on income, race, and geographic location (and the ...

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Health-E You / Salud iTu

Health-E You/Salud iTu is a mobile app for adolescents to support sexual/reproductive health decisions and prepare for clinician visits, including ...

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Using an iPad App in School Health Centers to Support ...

In this study, the research team tested the Health-E You/Salud iTu app in school-based health centers, or SBHCs, to help Latina teens learn about birth control ...

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Health-E You/Salud iTu™ is a novel, interactive, patient-centered, mobile health application (app) to support contraceptive decision-making and sexual/ ...

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An evidence-informed mobile health (mHealth) app, to provide interactive, individually tailored sexual health information and contraception decision support.