Male adolescents and clinicians participated in virtual focus group discussions and interviews, respectively, to inform Health-E You app updates for male adolescents. Male adolescents of any gender could participate if they were of male sex; aged 15 to 24 years; English or Spanish speaking; and able to provide informed consent and recruited via local and national youth advisory boards, youth-serving organization listservs, targeted social media posts, and referrals by enrolled participants. Clinicians could participate if they had an advanced clinical degree (eg, nurse practitioner, physician); currently practiced in the United States; served at least 10% male adolescent patients; and were recruited via professional listservs, coalitions, and conferences.

Focus group discussions with male adolescents explored perceptions and prioritization of different SRH topics across 3 sessions, feedback on app content using draft app pages (eg, information on condom use, STI and HIV prevention, healthy relationships, family planning), and the app’s look and feel after reviewing an updated interactive prototype developed based on findings from earlier sessions. Sessions were facilitated by a trained research member using a semistructured interview guide and conducted from April 2023 to February 2024. Each focus group session consisted of 2 to 5 participants, was conducted in English or Spanish, was stratified by age (aged 15-17 and 18-24 years) and gender identity (cisgender and gender expansive), and lasted approximately 60 to 90 minutes.

Interviews with clinicians explored perceptions of male adolescent patients’ sexual health needs, standard SRH care delivered, and areas where the Health-E You app could support SRH care delivery to male adolescents. Before the interview, clinicians completed a brief survey about their training history and confidence in and implementation of SRH care delivery to male adolescents. Interviews were conducted from May 2023 to March 2024 by a trained research member using a semistructured interview guide and lasted approximately 60 to 75 minutes.

We conducted qualitative data collection until data saturation was reached—the point at which additional data collection does not produce new information or themes [30,31]. All qualitative data were recorded and transcribed. Findings were used to develop the Health-E You app’s beta version programming by a third party.

We engaged our male youth DTAG members to test the app’s beta version, in which they worked via the app and provided feedback on its content, design, and flow. We used this feedback to inform app refinements.

We are subsequently conducting acceptability, usability, and satisfaction testing with 40 male adolescent patients and 10 clinicians. This pilot testing of the app started in May 2025 and will last approximately 6 months. Inclusion criteria for adolescents of any gender include male sex, aged 13 to 21, English or Spanish speaking, and able to provide informed consent. For this testing, eligible youth complete a brief baseline survey; then use Health-E You before their clinic appointment; and after their visit, complete an immediate post measurement survey (Table 1) and a debrief about their Health-E You experience to assess app acceptability, usability, and satisfaction, and any explanations for low app ratings [32-34]. Clinicians are asked to review and provide feedback on the app, including the app-generated patient summaries. Debrief sessions last approximately 30 to 45 minutes for male adolescents and 20 to 30 minutes for clinicians and are facilitated by a trained research member; the sessions are audio recorded and transcribed verbatim.

Collected qualitative data are being analyzed using a pragmatic approach adapted from inductive and deductive thematic analysis [42]. First, 3 study team members review transcripts to familiarize themselves with the data and then code together 2 to 3 transcripts to generate initial codes—based on discussion, interview guides, and emergent data patterns—and reach consensus on a codebook. Team members divide the remaining coding of transcripts, which is then reviewed by another team member. Coding questions or inconsistencies are resolved through weekly group discussions, with oversight from a senior team member, in which the team identifies, reviews, and names emergent themes related to app content, functionality, and design specifications.

We descriptively analyze quantitative data on perceived app acceptability, usability, and satisfaction and estimate the prevalence of agreement for each item within each scale (disagree and strongly disagree versus agree and strongly agree) using Stata 18 (StataCorp LLC) [43]. Any items that receive an agreement rating of less than 75% will be reviewed by the study team and DTAG members, alongside corresponding qualitative feedback, to identify possible areas of app improvement. We will then make these final improvements to the app before efficacy testing.

We will conduct the efficacy trial of Health-E You at 8 primary care settings that serve male adolescents aged 13 to 21 years from November 2025 for approximately 2 years. We recruited participating clinics through professional medical organization outreach and existing relationships. This trial has been registered on ClinicalTrials.gov (NCT06525064).

We will evaluate the app’s efficacy using a cluster randomized controlled stepped-wedge design, a one-way crossover design in which all clinics will begin the study in the control phase and then transition to the Health-E You intervention [44]. This design was chosen because it allows all sites to receive the intervention over the study course. Clinics will be stratified by adolescent patient population size (large versus small) and randomized into clusters within each stratum, which will dictate when they transition to the intervention phase during the 28-month study period.

Patients in participating clinics will be eligible to participate in the trial if they are male, are aged 13 to 21 years, report having had vaginal or anal sex in the previous 12 months, are able to provide informed consent, and if their preferred language is English or Spanish.

Consent procedures for this clinic-based study will follow state minor consent laws, which allow minors to provide consent for SRH care [45,46]. This approach upholds minor participants’ right to confidential SRH care, which is codified in each participating state’s minor consent laws and reiterated in national and federal clinical guidance for adolescent SRH care [4,5]. At each clinic, staff will share study materials (ie, flyers, banners, handout cards) with potentially eligible patients presenting for care that feature a QR code to the study’s eligibility survey, which can be completed on any device (eg, mobile phone, tablet, computer). Eligible adolescents will be electronically directed to a multimedia consent form containing an embedded video that describes the study’s purpose and design, including the number of surveys, estimated time requirements, remuneration, associated participation risks, expectations and implications of study participation, and the right to withdraw at any time without implications for their care. The video also includes a brief true or false quiz to reinforce important consent components and information on how to contact study team members (Multimedia Appendix 2).

Participants who provide consent will then be electronically autodirected to a brief baseline survey. When clinics are in the intervention phase, participants will then be autodirected to the Health-E You app after baseline survey completion. Using contact information collected at enrollment, participants will be sent a follow-up survey 48 hours after their clinic visit and then a second follow-up survey 2 months later. We use a HIPAA-compliant survey and data management software to manage all participant enrollment, data collection, and follow-up data.

Health-E You leverages mobile web technology to privately ask patients standard screening questions about their SRH before their clinic visit; provide needed SRH information and skill development activities; and then subsequently share a patient summary of SRH needs, concerns, questions, and recommended SRH care with clinicians based on their responses. The design of Health-E You is informed by the integrated behavioral model, which asserts that behavior (eg, condom use and SRH care use) is influenced by core constructs of behavioral attitudes, perceived norm beliefs, and personal agency (Figure 2) [47]. Specifically, Health‐E You aims to improve male adolescents’ SRH knowledge and self-efficacy to use condoms and talk with a clinician about SRH, which collectively may result in increased SRH care receipt during their clinic visit and subsequent condom use behaviors.

Similar to the app’s original version for female adolescents, male adolescents using the Health-E You app are guided through an initial question set related to sexual behavior, sexual health history, and family planning goals (Multimedia Appendix 3). Users are subsequently directed to a core condom use and other STI and HIV prevention methods (eg, vaccines and preexposure prophylaxis) content pathway—designed to be completed in 7 to 10 minutes. The core content is multimedia and interactive to accommodate different engagement preferences and reinforce the app’s messages (eg, brief condom demonstration video, interactive activity on condom use steps, animated informational videos provided by Amaze [48], videos from real clinicians and young people developed for this study, written content). Based on users’ family planning goals and interests, users may also receive content on hormonal pregnancy prevention methods and, for participants expecting a child, ways to support a pregnant partner or newborn.

After completing core content, each user is presented with a summary of recommended topics to discuss with their clinician and invited to select additional SRH topics and submit questions they would like to discuss with their clinician during their visit. Users are given the option to send this patient summary to their clinician securely by email or local printing at the clinic, based on the clinic’s preferred workflows. All Health-E You app data are programmed and hosted on the Drupal web-based interface and securely stored in the HIPAA-compliant Salesforce Platform (Salesforce Inc), which adheres to strict data security standards, including regular security updates.

When clinics are in the control condition, participants will receive care as usual.

In the baseline survey, participants are assessed for past SRH care receipt [10]; sexual behavior, including condom use [39,40]; SRH knowledge [35,36]; self-efficacy related to condom use [37] and talking to clinicians about SRH [38]; and background characteristics [10] (Table 1). At the first follow-up survey (48 hours after the visit), participants were assessed for SRH care receipt at the clinic visit, visit satisfaction, quality care receipt [41], and SRH knowledge and self-efficacy and, for participants in the intervention phase, acceptability [33,34], usability [32], and satisfaction [33] using the Health-E You app. At the second follow-up survey 2 months later, participants are assessed for the same baseline measures, including method use behaviors, and any additional app engagement (Table 1).

Strategies for participant retention from baseline through the follow-up surveys include participant remuneration, collecting multiple contacts at baseline and subsequent follow-ups (ie, phone number, email, etc), check-ins with participants between surveys, advising and providing US $5 gift cards to participants contacting us with changes in contact information, and sending reminder messages before conducting follow-up procedures [14,40].

We generated power analyses using NCSS PASS 16 to compute minimum detectable effect sizes for condom use at last intercourse [40]. Assuming 2064 participants at the 2-month follow-up (86 participants per clinic per assessment), α of .05, power of .80, and an intracluster correlation coefficient of 0.06 (calculated from previous Health-E You data with female individuals [14]) with a baseline prevalence of 61.1% condom use at last intercourse [40], the minimum detectable difference is 12.2 percentage points, which translates to an effect size (h) of 0.26, just above the accepted threshold for a small effect size of 0.20. A baseline sample of 2752 participants (approximately 115 participants per clinic per step) will be recruited to account for 79.9% (2201/2752) retention at immediate follow-up (48 hours) and 75% (2064/2752) retention at 2-month follow-up.

The main effects of the Health-E You intervention are being estimated using an intention-to-treat approach using separate mixed models for each study outcome, with a random intercept to reflect clustering of patients within clinics and adjustment for clinic size [49]. Each model estimates differences between the intervention and control arm in the change in each study outcome between baseline and each follow-up. This type of analysis allows for examining (1) within-individual change over time in an outcome, accounting for dependency among observations within individuals by modeling within-person error [50]; (2) between-individual variation over time [51]; and (3) between-subjects effects based on group assignment to identify significant differences in Health-E You versus usual care. We will also assess the potential moderating effect of patient demographics and adolescents’ visit reason, which may influence SRH care receipt, on the study’s outcomes. We are addressing incomplete data with maximum likelihood and multiple imputations [52-54]. The use of these missing replacement strategies does not mitigate loss of statistical power but does minimize bias because of attrition [55].

The investigative team at the Johns Hopkins School of Medicine, which is serving as the coordinating site for this multi-site randomized controlled trial, is serving as the data management team. This team will communicate any important protocol modifications to relevant parties, as appropriate, and in conjunction with the institutional review board. The investigative team comprises experts in adolescent health, male health, and evaluation research. We are using the World Health Organization’s Monitoring and Evaluating Digital Health Intervention guidelines to inform this study’s process monitoring of system factors, intervention quality, and intervention engagement [56]. We will assess technical functionality and stability through periodic user tests by the study team and routine app data monitoring to confirm the app is functioning as expected. We will assess intervention quality through the 48-hour follow-up survey, which will include questions on usability, acceptability, and satisfaction, including an overall app rating. We will track intervention engagement by monitoring whether participants complete core Health-E You content, opt in rates to share the patient summary with their clinician, time spent on Health-E You, and viewed content. We will provide monthly reports to participating clinics on these metrics and participant enrollment, which will provide an opportunity to gather clinic feedback to understand and address barriers with participant recruitment or sharing the patient summaries with clinicians. We will also collect online surveys before and after the intervention from clinicians and staff at each clinic about clinic workflows and visit times and postintervention about clinicians’ perceived acceptability and usability of and satisfaction with Health-E You to provide contextual information about the trial.

This study is guided by an internal data safety monitoring plan that includes staff training and monitoring related to participant privacy, confidentiality, and identification; response; and reporting of different possible events, adapted from recommendations by Horigian et al [57] (Multimedia Appendix 4). The data safety monitoring plan is managed by the principal investigator with oversight from a designated monitor external to the study team. This study is protected under a certificate of confidentiality from the National Institutes of Health that protects the research and Health-E You app data from subpoena.