跳至主要内容
临床试验/NCT03866811
NCT03866811已完成不适用

Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy

Columbia University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2019年3月3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
146
试验地点
1
主要终点
Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]

研究概览

简要总结

This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.

详细描述

Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population.

In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone.

At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.

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 (Outcomes Assessor)

盲法说明

The outcome assessor will be blinded to study enrollment arm.

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • female emergency department patient
  • age 14-19 years
  • sexually active with males in the past 3 months

排除标准

  • currently using any effective form of contraception
  • do not own a mobile phone with texting
  • are pregnant
  • are too ill for participation per the attending physician
  • are cognitively impaired
  • do not live locally
  • do not speak English
  • want to "become pregnant in the next year"

结局指标

主要结局

Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]

时间窗: 3 months

Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following: * intrauterine device * birth control implant * birth control patch * birth control pills or oral contraceptives * injectable birth control * a vaginal ring

次要结局

  • Feasibility: Percentage of Refusal(Baseline)
  • Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey(3 months)
  • Any Sex Over the Past 3 Months(1 year)
  • Feasibility: Opt Outs Measured Via Mobile Platform(3 months)
  • Number of Enrolled Participants Who do Not Complete Follow up(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren S. Chernick

Assistant Professor of Pediatrics in Emergency Medicine

Columbia University

研究点 (1)

Loading locations...

相似试验