Health-E You Efficacy Trial for Male Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age13-21
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Health-E You app
Other interventionWhen 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.
Treatment groups
2,752 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correct Condom Use Self-Efficacy Scale
Higher score indicates greater self-efficacy for correct use of male condoms. This measure is scaled with range from 1 (very difficult) to 5 (very easy); range 7-35.
Time frame
Baseline, 24 hours after visit, 2-month follow-up2
Perceived efficacy in patient-physician interactions (PEPPI)
Higher score indicates greater efficacy in patient-physician interaction about sexual and reproductive health. This measure is scaled with range from 1 (not at all confident) to 5 (very confident); range 5-25.
Time frame
Baseline, 24 hours after visit, 2-month follow-up3
Frequency condom use
Measures frequency condom use with main \& non-main partners in past year and last 2 months
Time frame
Baseline, 2-month follow-up4
Sexual and reproductive care receipt
Measures receipt of the recommended sexual and reproductive care package, based on national guidelines outlined by the Centers for Disease Control and Prevention (CDC) Office of Population Affairs (OPA) Quality Family Planning guidance \& American Academy of Pediatrics' Bright Futures
Time frame
Baseline, 24 hours after visit, 2-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov