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临床试验/NCT02816424
NCT02816424已完成不适用

Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care

University of New Mexico2 个研究点 分布在 1 个国家目标入组 447 人开始时间: 2015年11月11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
447
试验地点
2
主要终点
Proportion of participants endorsing unprotected sex at 3 month follow up

研究概览

简要总结

Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.

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
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Aged 13-19
  • Self-reported past year unprotected sex
  • Can read and speak English
  • Willing to be contacted for follow-up

排除标准

  • Current use of long-acting reversible contraceptives
  • Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation
  • Expressed suicidality
  • Obvious cognitive impairment
  • Inability to provide informed consent

结局指标

主要结局

Proportion of participants endorsing unprotected sex at 3 month follow up

时间窗: 3-Month Endpoint

All participants

Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up

时间窗: 3-Month Endpoint

Among female participants

次要结局

  • Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up(9-Month Endpoint)
  • Proportion of participants endorsing unprotected sex at 9 month follow up(9-Month Endpoint)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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