Health-E You Efficacy Trial for Male Adolescents

Not Applicable

Not yet recruiting

• Conditions: Sexual Health; Sexually Transmitted Diseases; Reproductive Health

• Registration Number: NCT06525064
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

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 12-21 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 (ST)I prevention methods, male method use self-efficacy, beliefs about male/female methods, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Study Start: 2025-09
• Primary Completion: 2027-08
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 1866

Inclusion Criteria

• Assigned male sex at birth
• Age 12 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 11 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sexual and reproductive care receipt	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
Frequency condom use	Baseline, 2-month follow-up	Measures frequency condom use with main \& non-main partners in past year and last 2 months
Correct Condom Use Self-Efficacy Scale	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)	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States