Health-E You Efficacy Trial for Male Adolescents
a study on Sexually Transmitted Infections Sexual Health
Summary
- Eligibility
- for males ages 13-21 (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
Summary
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.
Official Title
Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt
Details
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.
Keywords
Sexually Transmitted Diseases, Sexual Health, Reproductive Health, male adolescent, condom use, mhealth, Health-E You app
Eligibility
You can join if…
Open to males ages 13-21
- 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 CAN'T join if...
- 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
Locations
- UCSF Benioff Children's Hospital - Oakland
accepting new patients
Oakland California 94609 United States - Cincinnati Children's Hospital
accepting new patients
Cincinnati Ohio 45229 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Johns Hopkins University
- ID
- NCT06525064
- Study Type
- Interventional
- Participants
- Expecting 2752 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.