Recruiting

Health-E You

Sponsor:

Johns Hopkins University

Code:

NCT06525064

Conditions

Sexually Transmitted Diseases

Sexual Health

Reproductive Health

Eligibility Criteria

Sex: Male

Age: 13 - 21

Healthy Volunteers: Accepted

Interventions

Health-E You app

Study Details

Brief 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.

Conditions

Sexually Transmitted Diseases

Sexual Health

Reproductive Health

Study ID

NCT06525064

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 13 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2752 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Group

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.

experimental: Intervention Group

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.

Interventions

Health-E You app

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.

Primary outcome measure

  • Correct Condom Use Self-Efficacy Scale [ Time Frame: Baseline, 24 hours after visit, 2-month follow-up ]
  • Perceived efficacy in patient-physician interactions (PEPPI) [ Time Frame: Baseline, 24 hours after visit, 2-month follow-up ]
  • Frequency condom use [ Time Frame: Baseline, 2-month follow-up ]
  • Sexual and reproductive care receipt [ Time Frame: Baseline, 24 hours after visit, 2-month follow-up ]

Central Contacts and Locations

Central contacts

Arik V Marcell, MD, MPH

4432878946amarcell@jhu.edu

Sofia Osio, MSPH

sosiosm1@jh.edu

Locations

UCSF Benioff Children's Hospital - Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Lela Bachrach, MD, MS

510-428-3000lela.bachrach@ucsf.edu

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20012

Contacts

Sharyn Malcolm, MD, MPH

202-476-2904smalcolm@childrensnational.org

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Arik Marcell, MD, MPH

443-676-2378amarcell@jhu.edu

Mount Sinai Health System

Recruiting

New York, New York, United States, 10128

Contacts

Wendy Neal, MD

wendy.neal@mountsinai.org

Upstate University Hospital

Recruiting

Syracuse, New York, United States, 13210

Contacts

Aimee Steiniger, MD

315-464-4357steiniga@upstate.edu

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Emmanuel Chandler, MD

513-636-4200emmanuel.chandler@cchmc.org

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Ryan Spotts, MD

800-243-1455rspotts@pennstatehealth.psu.edu

Brody Lipsett, MD

717-361-0666blipsett@pennstatehealth.psu.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Renata Renata, MD, MPH, ScM

215-590-3537sandersr2@chop.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • male adolescent
  • condom use
  • mhealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-15.