Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525064
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Health-E You Efficacy Trial for Male Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Health-E YouSalud iTu Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual Reproductive Healthcare Receipt
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will involve evaluating Health-E YouSalud 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 12-21 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 ie condom use as well as knowledge about pregnancy and sexually transmitted infection STI prevention methods male method use self-efficacy beliefs about malefemale methods improved knowledge about SRH care self-efficacy talking with a clinician about SRH beliefs about SRH promotion and SRH care receipt
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None