Health-E You Efficacy Trial for Male Adolescents

Part of paid clinical trials in Oakland, California.

Sponsor
Johns Hopkins University
Study ID
NCT06525064
Status
Recruiting
Apply to this trial

Conditions

  • Reproductive Health
  • Sexual Health
  • Sexually Transmitted Diseases

Eligibility Criteria

Sex
MALE
Age
13 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Health-E You app — OTHER
    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 for administration to the Health-E You app. Participants will be considered to have completed the Health-E You app if the participants answer all of the app's initial tailoring questions and receive recommendations for SRH topics to discuss with the clinician. As a technology-based intervention, no direct interactions with interventionists with participants are required.

Study Details

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.

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
2,752 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • No Intervention: Control Group
    When clinics are in the control condition, patients will receive usual care. Before the visit eligible participants will receive a weblink to study information, and if agree to participate, the survey. The participants will not be presented Health-E You content and clinicians will not receive output to prime the visit; the participants will receive usual care as typical. Previously enrolled control males will not be enrolled during intervention periods to maintain the research study's integrity.
  • Experimental: Intervention Group
    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 for administration to the Health-E You app. Participants will be considered to have completed the Health-E You app if the participants answer all of the app's initial tailoring questions and receive recommendations for SRH topics to discuss with the clinician. As a technology-based intervention, no direct interactions with interventionists with participants are required.

Primary Outcome Measure

Correct Condom Use Self-Efficacy Scale [ Time Frame: Baseline, 24 hours after visit, 2-month follow-up ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's Hospital - OaklandOaklandCalifornia94609
Lela Bachrach, MD, MS
[email protected]
510-428-3000
Children's National HospitalWashington D.C.District of Columbia20012
Sharyn Malcolm, MD, MPH
[email protected]
202-476-2904
Johns Hopkins UniversityBaltimoreMaryland21287
Arik Marcell, MD, MPH
[email protected]
443-676-2378
Mount Sinai Health SystemNew YorkNew York10128
Wendy Neal, MD
[email protected]
Upstate University HospitalSyracuseNew York13210
Aimee Steiniger, MD
[email protected]
315-464-4357
Cincinnati Children's HospitalCincinnatiOhio45229
Emmanuel Chandler, MD
[email protected]
513-636-4200
Penn State HealthHersheyPennsylvania17033
Ryan Spotts, MD
[email protected]
800-243-1455
Brody Lipsett, MD
[email protected]
717-361-0666
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Renata Renata, MD, MPH, ScM
[email protected]
215-590-3537

Find similar trials in Oakland, CA

By research site
UCSF Benioff Children's Hospital - Oakland· Oakland, CAChildren's National Hospital· Washington D.C., DCJohns Hopkins University· Baltimore, MDMount Sinai Health System· New York, NYUpstate University Hospital· Syracuse, NYCincinnati Children's Hospital· Cincinnati, OH

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