Clinical trial NCT06525064: Health-E You Efficacy Trial for Male Adolescents
Official title: Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexually Transmitted Diseases
Sexual Health
Reproductive Health
Keywords: male adolescent
condom use
mhealth
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-29
Enrollment: 1866
Sex: MALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will use a cluster-randomized stepped-wedge design that is a type of one-way crossover design. Under this design, each clinic will start the study under the control condition that involves standard usual care, and end the study in the intervention condition.
Primary purpose: PREVENTION

Brief 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.

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 (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (ST)I prevention methods, male method use self-efficacy, beliefs about male/female methods, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.

Eligibility criteria: Inclusion Criteria:

* Assigned male sex at birth
* Age 12 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

Exclusion Criteria:

* Aged 11 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

Primary outcomes:
measure: Correct Condom Use Self-Efficacy Scale
timeFrame: Baseline, 24 hours after visit, 2-month follow-up
measure: Perceived efficacy in patient-physician interactions (PEPPI)
timeFrame: Baseline, 24 hours after visit, 2-month follow-up
measure: Frequency condom use
timeFrame: Baseline, 2-month follow-up
measure: Sexual and reproductive care receipt
timeFrame: Baseline, 24 hours after visit, 2-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
name: Arik V Marcell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akande M, Aturaliya R, Osio Smith S, Smith A, Arrington-Sanders R, Tebb K, Marcell AV. Integrating Young Male Voices to Enhance Sexual and Reproductive Healthcare Uptake of Innovative Pre-Clinic Technology. Journal of Adolescent Health. 2024;74(3 Suppl):S2.
citation: Tebb KP, Rodriguez F, Pollack LM, Adams S, Rico R, Renteria R, Trieu SL, Hwang L, Brindis CD, Ozer E, Puffer M. Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu. Contraception. 2021 Sep;104(3):246-253. doi: 10.1016/j.contraception.2021.03.004. Epub 2021 Mar 17.