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临床试验/NCT01969305
NCT01969305已完成不适用

A Computerized Family-Based Youth HIV and Drug Abuse Prevention in Kazakhstan

University of Chicago1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
181
试验地点
1
主要终点
Change in onset and 30-day alcohol and drug use from baseline to 6 months

研究概览

简要总结

This pilot study will adapt and test the feasibility and estimate the effect size parameters of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females and males living in communities highly affected by heroin trade and use in Almaty, Kazakhstan.

详细描述

The purpose of this study is to adapt an evidence-based HIV and substance use prevention intervention for most at-risk adolescents and their caregivers (parents or other adult family members) from drug-risk communities in Kazakhstan. Located on major drug trafficking routes (between Afghanistan, the world's largest opium producer, and Russia), Central Asia and Kazakhstan, in particular, face one of the fastest growing rates of HIV infection in the world disproportionately affecting young people ages 15-29. Youth exposed to drugs at home and in the community are particularly at risk.

The country's HIV prevention efforts for youth are limited to a knowledge-based approach, which does not equip at-risk youth with skills required to deal with situations of risk exposure. Parents or other caregivers, who represent a significant protective force in a family-oriented culture of Central Asia, are largely excluded from youth prevention efforts in Kazakhstan.

KFT is a family-based multi-media intervention designed to reduce sexual and drug-related risks for HIV infection among at-risk adolescents. To address the dual risk of HIV and substance use, the proposed intervention combines empirically tested skills-based and family involvement approaches and utilizes multi-media computer technology to develop an engaging and potentially cost-effective tool with high fidelity and easy scalability. During each of the sessions, youth and caregivers will participate in interactive computer activities to learn skills and have conversations focused on risky behaviors.

During the development stage, the US and Kazakhstani investigative team will conduct formative research and will work closely with the local Community Collaborative Board to adapt the intervention to the cultural context of at-risk families in Kazakhstan.

Further, the KFT intervention will be tested in a pilot Randomized Controlled Trial with 248 adolescents and 248 of their caregivers. Intervention arm adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, and caregiver-adolescent communication, support and monitoring. Adolescents from both intervention and control arms will receive the usual care services available for at-risk youth, which includes health education sessions on HIV and drug use delivered by peer educators and outreach workers.

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 (Participant)

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Youth are between the ages of 14-
  • Youth exhibits one of the following risk factors: substance-using peers or friends, parental history of drug use, parental history of alcohol problems, parental criminal history, adolescent's history of drug use, running away from home, school drop-out or history of sexual activity.
  • You and caregiver are able to speak and read Russian.
  • Both youth and caregiver (parent or other caregiving adult family member) can commit to study participation.
  • Youth and caregiver do not plan to move in the next 6 months.

排除标准

  • Youth are under the age of 14 or over the age of
  • Youth does not exhibit one of the aforementioned risk factors.
  • Youth and caregiver do not speak and read Russian.
  • Youth and caregiver are unable to commit to study participation.
  • Youth or caregiver has plans to move within the next 6 months.
  • Youth or caregiver has a cognitive impairment.

研究组 & 干预措施

Kazakhstani Family Together (KFT)

Experimental

Usual Care Plus KFT: Family-based multi-media HIV and drug abuse prevention intervention

干预措施: Kazakhstani Family Together (Behavioral)

Health education curriculum

Experimental

Usual Care Alone: Health education curriculum on HIV and drug use prevention

干预措施: Usual Care Alone (Behavioral)

结局指标

主要结局

Change in onset and 30-day alcohol and drug use from baseline to 6 months

时间窗: Up to 6-months

Measures will ask youth to report the frequency and quantity of alcohol and drug use in the past 30 days (number of alcoholic drinks, puffs of marijuana, or initiation of injection drug use). Substance use includes specific probes, including street names for alcohol, marijuana, ecstasy, cocaine, injecting drug use, heroin, inhalants, hallucinogens, and other drugs as appropriate to the context.

次要结局

  • Change in onset and sexual risk behaviors from baseline to 6 months(Up to 6-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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