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NCT Number: NCT06525064

Health-E You Efficacy Trial for Male Adolescents

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.

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Key information

Conditions

Sexually Transmitted Diseases Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Reproductive Health Sexual Health Urogenital Diseases

Age range

13 year–21 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital - Oakland, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health-E You app

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arik V Marcell, MD, MPH

CONTACT

[email protected]

4432878946

Sofia Osio, MSPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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