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临床试验/NCT01910714
NCT01910714已完成不适用

Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
267
试验地点
2
主要终点
Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up

研究概览

简要总结

The investigators seek to adapt, implement and evaluate a randomized controlled trial of an evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk, targeting Apache adolescents. Specific study objectives include:

  1. To perform formative research through focus groups and individual interviews on attitudes, practices and intervention preferences among Apache adolescents and community stakeholders.
  2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the formative research, components of Protection Motivation Theory, and input from a community advisory board.
  3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized intervention trial measuring behavior change at 6- and 12- months follow-up.
  4. To determine the feasibility of gathering biological specimens via self-administered swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and future studies.

详细描述

The general format of the study consists of a randomized controlled trial delivered through the medium of an 8-day basketball camp. Intervention activities will consist of the daily delivery of a youth HIV/AIDS prevention curriculum over the course of 8 days.

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
None

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

  • American Indian ethnicity and primary residence and/or employment within the White Mountain Apache (Fort Apache) Reservation. Participants must be aged 13-19 years and have parent/guardian consent for youth under 18 years old.

排除标准

  • Youth that are unable to fully participate in the evaluation assessments or intervention components will be excluded. In addition, individuals age 16 or older that are listed on either the Federal or Tribal sexual offender registries will be excluded from participation.

结局指标

主要结局

Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up

时间窗: 12 months follow-up

次要结局

  • Improved score on scale of HIV prevention knowledge, intention and perceptions in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Improved score on scale of partner negotiation skills related to sex and drug use between treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Higher age of sexual initiation in treatment vs. control group at 12 months follow-up(12 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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