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Health-E You Efficacy Trial for Male Adolescents

Johns Hopkins University · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06525064

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 13–21 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
2752
US sites recruiting
8
Study start
June 2, 2026
Record last updated
July 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Health-E You app

Conditions: Sexually Transmitted Diseases; Sexual Health; Reproductive Health

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • UCSF Benioff Children's Hospital - Oakland

    Oakland, CA 94609

    Site contact: Lela Bachrach, MD, MS · 510-428-3000 · lela.bachrach@ucsf.edu

  • Children's National Hospital

    Washington D.C., DC 20012

    Site contact: Sharyn Malcolm, MD, MPH · 202-476-2904 · smalcolm@childrensnational.org

  • Johns Hopkins University

    Baltimore, MD 21287

    Site contact: Arik Marcell, MD, MPH · 443-676-2378 · amarcell@jhu.edu

  • Mount Sinai Health System

    New York, NY 10128

    Site contact: Wendy Neal, MD · wendy.neal@mountsinai.org

  • Upstate University Hospital

    Syracuse, NY 13210

    Site contact: Aimee Steiniger, MD · 315-464-4357 · steiniga@upstate.edu

  • Cincinnati Children's Hospital

    Cincinnati, OH 45229

    Site contact: Emmanuel Chandler, MD · 513-636-4200 · emmanuel.chandler@cchmc.org

  • Penn State Health

    Hershey, PA 17033

    Site contact: Ryan Spotts, MD · 800-243-1455 · rspotts@pennstatehealth.psu.edu

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Renata Renata, MD, MPH, ScM · 215-590-3537 · sandersr2@chop.edu

Study contacts (from the official record)

  • Arik V Marcell, MD, MPH · 4432878946 · amarcell@jhu.edu
  • Sofia Osio, MSPH · sosiosm1@jh.edu
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Health-E You Efficacy Trial for Male Adolescents (NCT06525064) | Bored Studies