Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,752
- 试验地点
- 8
- 主要终点
- Frequency condom use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Health-E You app (Other)
结局指标
主要结局
Frequency condom use
时间窗: Baseline, 2-month follow-up
Measures frequency condom use with main \& non-main partners in past year and last 2 months
Correct Condom Use Self-Efficacy Scale
时间窗: Baseline, 24 hours after visit, 2-month follow-up
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.
Perceived efficacy in patient-physician interactions (PEPPI)
时间窗: Baseline, 24 hours after visit, 2-month follow-up
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.
Sexual and reproductive care receipt
时间窗: Baseline, 24 hours after visit, 2-month follow-up
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
次要结局
未报告次要终点