Health-E You Efficacy Trial for Male Adolescents

Official title

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

Overview

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 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.

Interventions

• Other Health-E You app
  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 f

Primary outcome measures

• Correct Condom Use Self-Efficacy Scale [Time frame: Baseline, 24 hours after visit, 2-month follow-up]
• Perceived efficacy in patient-physician interactions (PEPPI) [Time frame: Baseline, 24 hours after visit, 2-month follow-up]
• Frequency condom use [Time frame: Baseline, 2-month follow-up]
• Sexual and reproductive care receipt [Time frame: Baseline, 24 hours after visit, 2-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 8 centers

• UCSF Benioff Children's Hospital - Oakland — Oakland
• Children's National Hospital — Washington D.C.
• Johns Hopkins University — Baltimore
• Mount Sinai Health System — New York
• Upstate University Hospital — Syracuse
• Cincinnati Children's Hospital — Cincinnati
• Penn State Health — Hershey
• Children's Hospital of Philadelphia — Philadelphia

Publications

• 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.
• 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 33744300
• 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 41092393

Identifiers

NCT: NCT06525064 · IRB00424416 · R01HD109141

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗