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临床试验/NCT03400410
NCT03400410已完成不适用

Hormonal Contraceptive Health Education for Adolescent Males in the Pediatric Emergency Department

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
Discussion rates

研究概览

简要总结

Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.

详细描述

Unintended pregnancy among adolescents is a significant public health issue and U.S. adolescents have one of the highest unintended pregnancy rates among industrialized nations. An estimated 9% of male adolescents becoming fathers by the time they are 20 years old. Over 14 million adolescents use emergency departments every year and many of the adolescent males that present to the ED are engaged in high risk sexual behaviors which puts them at high risk for unintended pregnancy. This presents an opportunity to educate males that are at high risk about pregnancy prevention.

This study is a prospective randomized control trial of education about female hormonal contraception for these higher risk adolescent males, 15-21 years old, that present to the Saint Louis Children's Hospital pediatric emergency department. An electronic application will be used to take a sexual history and ask questions about patients' current attitudes and use of hormonal contraception with their partners. They will then be randomized to watch a video on female hormonal contraception (experimental group) or no video (control group). The video will be an overview with brief pros and cons of all available types of hormonal contraception. The app emphasizes importance of condom use as part of dual method protection throughout. All patients will be followed up in 3 months to complete a survey with similar questions on sexual history, discussions with partners, and current contraceptive practices. The hypothesis of the study is that this will lead to increased rates of discussion about hormonal contraception between male adolescents and their sexual partners. This may lead to increased contraceptive use rates and a decrease in unintended pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The investigator assigned to follow up will be masked to which group a participant was assigned to.

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Male adolescents 15-21 years of age that are sexually active and have ever had vaginal sex that present to the St Louis Children's Hospital pediatric emergency department.

排除标准

  • Males that have never had vaginal sex
  • Require activation of the trauma system
  • Triage as high severity (level 1 or level 2)
  • Present for evaluation of abuse, sexual assault, or psychiatric issues
  • Unable to speak English
  • Wards of the state
  • Disabilities that prevent independent use of a tablet device
  • Have not completed the electronic adolescent health questionnaire that is standard of care in our emergency department as this is needed for screening purposes

结局指标

主要结局

Discussion rates

时间窗: 3 months

Discussion rates of male adolescents with partner(s) about hormonal contraception.

次要结局

  • Fatherhood(Baseline (at initial contact) and 3 months)
  • Male value of partner discussion and hormonal contraceptive knowledge(3 months)
  • Partner use of hormonal contraception(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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