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NCT06525064NARecruitingAccepts Healthy Volunteers

Health-E You Efficacy Trial for Male Adolescents

Johns Hopkins University

Start Date

6/2/2026

Completion Date

5/1/2028

Summary

This study will involve evaluating Health-E You/Salud ìTu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (SRH) topics and care. It will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

Detailed Description

Health-E You is a pre-visit, web-based mobile app designed to support an adolescent male youth and his clinician in discussing SRH topics and care. It is shared with an adolescent patient prior to a clinic visit, and contains initial questions that subsequently provide the patient with individually-tailored health information. In addition, the app provides relevant information to the clinician on patients' SRH to optimize the time together as part of the visit. In total, the app takes approximately 10-15 minutes to complete. The purpose of this study is to evaluate the efficacy of the Health-E You app among male youth ages 13-21 using a cluster-randomized stepped-wedge design. A participant will be considered to have completed the study if the participant has completed the baseline assessment, worked through the app, an immediate follow-up assessment, and a 2-month post-visit follow-up assessment. The end of the study is defined as completion of the 2-month follow-up assessment. Hypotheses include compared to usual care, app users will have greater improvements in male method use behaviors (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (STI) prevention methods, male method use self-efficacy, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.

Eligibility Criteria

Age Range: 13 years to 21 years

Inclusion Criteria: * Assigned male sex at birth * Age 13 to 21 years old * English and/or Spanish as preferred language to read, listen, and converse * Self-reported engagement in vaginal and/or anal sex in the past 12 months * Access to phone or internet for follow-up study activities Exclusion Criteria: * Aged 12 or younger or older than 21 * Primary language other than English or Spanish * Not able to provide informed consent * Unable to communicate due to cognitive, mental, language, or other difficulties * Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex. * Previous participation in a Health-E You study activity or the app

Interventions

OTHER

Health-E You app

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Conditions

Sexually Transmitted DiseasesSexual HealthReproductive Health

Locations

UCSF Benioff Children's Hospital - Oakland

Oakland, California 94609

United States

Children's National Hospital

Washington D.C., District of Columbia 20012

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Mount Sinai Health System

New York, New York 10128

United States

Upstate University Hospital

Syracuse, New York 13210

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Penn State Health

Hershey, Pennsylvania 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States