NCT06525064

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,752

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

July 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

July 18, 2024

Last Update Submit

June 3, 2026

Conditions

Sexually Transmitted DiseasesSexual HealthReproductive Health

Keywords

male adolescentcondom usemhealth

Outcome Measures

Primary Outcomes (4)

  • Correct Condom Use Self-Efficacy Scale

    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.

    Baseline, 24 hours after visit, 2-month follow-up

  • Perceived efficacy in patient-physician interactions (PEPPI)

    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.

    Baseline, 24 hours after visit, 2-month follow-up

  • Frequency condom use

    Measures frequency condom use with main \& non-main partners in past year and last 2 months

    Baseline, 2-month follow-up

  • Sexual and reproductive care receipt

    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

    Baseline, 24 hours after visit, 2-month follow-up

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Other: Health-E You app

Interventions

Health-E You appOTHER

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.

Intervention Group

Eligibility Criteria

Age13 Years - 21 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCSF Benioff Children's Hospital - Oakland

Oakland, California, 94609, United States

RECRUITING

Children's National Hospital

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

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Mount Sinai Health System

New York, New York, 10128, United States

RECRUITING

Upstate University Hospital

Syracuse, New York, 13210, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (3)

  • Akande M, Aturaliya R, Osio Smith S, Smith A, Arrington-Sanders R, Tebb K, Marcell AV. Integrating Young Male Voices to Enhance Sexual and Reproductive Healthcare Uptake of Innovative Pre-Clinic Technology. Journal of Adolescent Health. 2024;74(3 Suppl):S2.

    BACKGROUND

  • Tebb KP, Rodriguez F, Pollack LM, Adams S, Rico R, Renteria R, Trieu SL, Hwang L, Brindis CD, Ozer E, Puffer M. Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu. Contraception. 2021 Sep;104(3):246-253. doi: 10.1016/j.contraception.2021.03.004. Epub 2021 Mar 17.

    PMID: 33744300BACKGROUND

  • Marcell AV, Smith AD, Osio Smith S, Akande M, Rohlff S, Arrington-Sanders R, Tebb K. A Previsit Mobile Health App (Health-E You/Salud iTu) for Male Adolescents to Promote Sexual and Reproductive Health Care Receipt: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 15;14:e77780. doi: 10.2196/77780.

    PMID: 41092393DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arik V Marcell, MD, MPH

    Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arik V Marcell, MD, MPH

CONTACT

4432878946amarcell@jhu.edu

Sofia Osio, MSPH

CONTACT

sosiosm1@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This study will use a cluster-randomized stepped-wedge design that is a type of one-way crossover design. Under this design, each clinic will start the study under the control condition that involves standard usual care, and end the study in the intervention condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 29, 2024

Study Start

June 2, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

The final version of collected data will be made available within thirty (30) months after the end of the data collection. Data will be preserved and made accessible along with the data codebook and other relevant documentation via the chosen repository. The investigators will make the data available through restricted/controlled access. Open Inter-university Consortium for Political and Social Research's (ICPSR's) Traditional Restricted Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to approved researchers.

Locations

US(8)