NCT06525064 · Johns Hopkins University
Health-E You Efficacy Trial for Male Adolescents
What this 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 effectiveness among male patients in clinical settings using a stepped wedge cluster randomly assigned controlled trial design.
View original scientific description
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.
Interventions
OTHER
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 measures
Correct Condom Use Self-Efficacy Scale
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Higher score indicates greater self-efficacy for correct use of male condoms. This measure is scaled with range from 1 (very difficult) to 5 (very easy); range 7-35.
Perceived efficacy in patient-physician interactions (PEPPI)
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Higher score indicates greater efficacy in patient-physician interaction about sexual and reproductive health. This measure is scaled with range from 1 (not at all confident) to 5 (very confident); range 5-25.
Frequency condom use
Time frame: Baseline, 2-month follow-up
Measures frequency condom use with main \& non-main partners in past year and last 2 months
Sexual and reproductive care receipt
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Measures receipt of the recommended sexual and reproductive care package, based on national guidelines outlined by the Centers for Disease Control and Prevention (CDC) Office of Population Affairs (OPA) Quality Family Planning guidance \& American Academy of Pediatrics' Bright Futures
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Oakland, California
- Washington D.C., District of Columbia
- Baltimore, Maryland
- New York, New York
- Syracuse, New York
- Cincinnati, Ohio
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations