Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu.
Kathleen P Tebb, Felicia Rodriguez, Lance M Pollack...
https://pubmed.ncbi.nlm.nih.gov/33744300Actively Recruiting
Phase Not Applicable
Age: 13Years - 21Years
MALE
Healthy Volunteers
ID06525064
Health-E You/Salud iTu Pre-visit Mobile App for Male Adolescents to Promote Sexual and Reproductive Healthcare
Led by Johns Hopkins University · Updated on 2026-06-05
2752
Participants Needed
8
Research Sites
17 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Health-E You/Salud iTu, a web-based mobile app designed to help adolescent males and their clinicians discuss sexual and reproductive health (SRH) topics. This study focuses on male youth ages 13 to 21 and aims to test the app's effectiveness in clinical settings using a stepped wedge cluster randomized controlled trial. The goal is to improve condom use behaviors, knowledge about pregnancy and STI prevention, self-efficacy in male method use, and communication with clinicians about SRH. The app is provided to participants before their clinic visit and takes about 10 to 15 minutes to complete. It offers tailored health information based on initial questions answered by the adolescent and shares relevant patient information with clinicians to support the visit. Clinics alternate between usual care and the intervention, with participants either receiving the app or standard care, ensuring that each participant only uses the app once. The study involves no direct interaction with interventionists. Participants will complete a baseline assessment, use the app if in the intervention group, and then complete follow-up assessments immediately after the visit and two months later. Researchers will measure outcomes including condom use self-efficacy, patient-physician interaction efficacy, frequency of condom use, and receipt of sexual and reproductive care. The study spans from baseline through a 2-month post-visit follow-up, marking the end of participation.
CONDITIONS
Brief Title
Health-E You Efficacy Trial for Male Adolescents
Who Can Participate
Age: 13Years - 21Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age 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 since last vaginal and/or anal sex
- Previous participation in a Health-E You study activity or the app
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Single pre-visit completion
Participants complete the Health-E You app before their clinic visit, which takes approximately 10-15 minutes and provides tailored sexual and reproductive health information to support discussions with their clinician.
1 visit (pre-visit app completion)
Follow-up
Duration - 2 months after the clinic visit
Participants complete an immediate follow-up assessment after the visit and a 2-month post-visit follow-up assessment to evaluate changes in sexual and reproductive health behaviors and knowledge.
2 follow-up assessments (immediate and 2-month post-visit)
Trial Site Locations
Total: 8 locations
1
UCSF Benioff Children's Hospital - Oakland
Oakland, California, United States, 94609
Actively Recruiting
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20012
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Mount Sinai Health System
New York, New York, United States, 10128
Actively Recruiting
5
Upstate University Hospital
Syracuse, New York, United States, 13210
Actively Recruiting
6
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Penn State Health
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
A
Arik V Marcell, MD, MPH
S
Sofia Osio, MSPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
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.
Arik V Marcell, Annie D Smith, Sofia Osio Smith...
https://pubmed.ncbi.nlm.nih.gov/41092393