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.
Marcell A, Smith A, et al. • JMIR research protocols • 2025
This protocol describes a two-stage study to adapt and evaluate a previsit mobile health app (Health-E You/Salud iTu) for male adolescents to improve sexual and reproductive health care receipt and condom use in primary care settings.
Key Findings
Background
Male adolescents have significant sexual and reproductive health (SRH) needs but receive poor SRH care despite national guidelines.
The authors identify a gap between existing national guidelines for SRH care and actual care receipt among male adolescents.
Technology-based interventions have successfully supported adolescents' SRH but have primarily focused on female individuals.
No existing technology solutions support comprehensive SRH care delivery for male adolescents in primary care settings.
Background
Health-E You/Salud iTu was originally designed for female youth and has proven effective in improving contraceptive care delivery and use.
The app is a mobile web app accessed ahead of a clinic appointment.
It contains initial screening questions, interactive knowledge items, and contraception decision support with tailored recommendations based on users' input.
The app provides clinicians with a summary of patients' recommended SRH care.
The current study aims to adapt this proven app for use with diverse groups of male adolescents.
Methods
Stage 1 of the study involves formative research, design, and user testing of Health-E You adapted for male adolescents using a youth-centered design process.
The youth-centered design process used multiple rounds of qualitative data collection and engaged youth and clinician advisors.
Design activities occurred from April 2023 through April 2024.
Beta testing of the app with youth and its output with clinicians is planned from May 2025 for approximately 6 months.
Transcripts from interviews and focus groups will be analyzed using deductive and inductive thematic analysis to identify knowledge and skill gaps and desired app features.
Quantitative data will be analyzed using descriptive statistics.
Methods
Stage 2 will involve a stepped-wedge cluster randomized controlled trial across 8 primary care settings in the United States with 2752 participants.
The trial will assess the impact of Health-E You on sexually active male adolescents' SRH care receipt and condom use.
The study will be conducted across 8 primary care settings across the United States.
Data will be analyzed with an intention-to-treat approach using separate mixed models for each study outcome.
Mixed models will include a random intercept to reflect clustering of patients within clinics, adjusted for clinic size.
The trial is registered at ClinicalTrials.gov (NCT06525064).
Methods
The study is designed to produce qualitative and quantitative data on feasibility, acceptability, and usability of Health-E You in clinical settings for male adolescents.
User testing will provide both qualitative and quantitative data on the app's feasibility, acceptability, and usability.
Results will include qualitative data on male adolescents' and clinicians' perspectives on SRH care receipt and delivery, respectively.
Results will also include data on preferences for app design from both youth and clinician perspectives.
Results
The efficacy trial will evaluate the extent to which the adapted app improves SRH care receipt and condom use among sexually active male adolescents.
Primary outcomes include SRH care receipt and condom use among sexually active male adolescents.
The findings are intended to inform future technology-based interventions for male adolescents.
The study aims to improve male adolescents' SRH care receipt in primary care settings more broadly.
What This Means
This research describes the design and planned testing of a smartphone-friendly app called Health-E You/Salud iTu, adapted specifically for teenage boys and young men. The app is used before a doctor's visit and helps young male patients think through their sexual and reproductive health needs — such as condom use and STI testing — and then shares a summary with their doctor so important health topics are more likely to be discussed during the appointment. An earlier version of this app designed for girls and young women was already shown to improve contraceptive care, and this study aims to extend that benefit to male adolescents, who currently receive poor sexual and reproductive health care despite national recommendations calling for it.
The study is being carried out in two stages. The first stage involved working directly with male teenagers and their doctors to design the app, using interviews, focus groups, and feedback rounds from April 2023 through early 2025. The second stage is a large clinical trial involving 2,752 participants across 8 primary care clinics in the United States, using a 'stepped-wedge' design where clinics gradually introduce the app over time. This design allows researchers to compare health outcomes before and after each clinic starts using the app.
This research suggests that a well-designed previsit app tailored for male adolescents could help bridge the gap between what sexual and reproductive health care guidelines recommend and what young men actually receive during routine doctor visits. If effective, this approach could offer a scalable, low-burden way to improve health outcomes for a group that has historically been underserved by sexual health interventions. The findings could also guide the development of similar technology tools for other underserved groups in healthcare settings.
Marcell A, Smith A, Osio Smith S, Akande M, Rohlff S, Arrington-Sanders R, et al.. (2025). 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 research protocols. https://doi.org/10.2196/77780