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临床试验/NCT00859144
NCT00859144已完成3 期

Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 901 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
901
试验地点
1
主要终点
Collaboration by HIV educators

研究概览

简要总结

This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.

详细描述

HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.

This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.

In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.

In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.

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 (Participant, Care Provider)

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult community HIV educators who are parents of a middle or high school aged child
  • •Adult participants must be between 25 and 60 years of age
  • •Youth participants must be between 12 and 15 years of age
  • •Residents of target communities in Bronx, NY

排除标准

  • •Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
  • •Significant cognitive impairment that might interfere with understanding of program content or informed consent process

研究组 & 干预措施

BART

Experimental

Participants will complete the Becoming a Responsible Teen (BART) program.

干预措施: Becoming A Responsible Teen (BART) (Behavioral)

Reducing the Risk

Experimental

Participants will complete the Reducing the Risk program.

干预措施: Reducing the Risk (Behavioral)

Be Proud Be Responsible

Active Comparator

Participants will complete the Be Proud! Be Responsible! program.

干预措施: Be Proud! Be Responsible! (Behavioral)

结局指标

主要结局

Collaboration by HIV educators

时间窗: Measured at 15-month follow-up

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Youth negotiation of sexual risk situations

时间窗: Measured after 15 months

Measured at baseline, after 3 to 4 months, and after 15 months

HIV educators' intentions to collaborate

时间窗: Measured at 15-month follow-up

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Youth sexual risk behaviors

时间窗: Measured after 15 months

Measured at baseline, after 3 to 4 months, and after 15 months

Youth sexual behavior

时间窗: Measured after 15 months

Measured at baseline, after 3 to 4 months, and after 15 months

Youth sexual risk behaviors

时间窗: Measured at baseline

Measured at baseline, after 3 to 4 months, and after 15 months

Youth sexual risk behaviors

时间窗: Measured after 3 to 4 months

Measured at baseline, after 3 to 4 months, and after 15 months

HIV educators' intentions to collaborate

时间窗: Measured at baseline

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

HIV educators' intentions to collaborate

时间窗: Measured at post-intervention

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

HIV educators' intentions to collaborate

时间窗: Measured at 3-month follow-up

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Collaboration by HIV educators

时间窗: Measured at baseline

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Collaboration by HIV educators

时间窗: Measured at post-intervention

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Collaboration by HIV educators

时间窗: Measured at 3-month follow-up

Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

Youth sexual behavior

时间窗: Measured at baseline

Measured at baseline, after 3 to 4 months, and after 15 months

Youth sexual behavior

时间窗: Measured after 3 to 4 months

Measured at baseline, after 3 to 4 months, and after 15 months

Youth negotiation of sexual risk situations

时间窗: Measured at baseline

Measured at baseline, after 3 to 4 months, and after 15 months

Youth negotiation of sexual risk situations

时间窗: Measured after 3 to 4 months

Measured at baseline, after 3 to 4 months, and after 15 months

次要结局

  • Leadership skills of HIV educators(Measured at 15-month follow-up)
  • Self-esteem and self-efficacy of HIV educators(Measured at 15-month follow-up)
  • HIV/AIDS knowledge and attitudes of educators and youth(Measured after 15 months)
  • Leadership skills of HIV educators(Measured at baseline)
  • Leadership skills of HIV educators(Measured at post-intervention)
  • Leadership skills of HIV educators(Measured at 3-month follow-up)
  • HIV/AIDS knowledge and attitudes of educators and youth(Measured at baseline)
  • HIV/AIDS knowledge and attitudes of educators and youth(Measured after 3 to 4 months)
  • Self-esteem and self-efficacy of HIV educators(Measured at baseline)
  • Self-esteem and self-efficacy of HIV educators(Measured at post-intervention)
  • Self-esteem and self-efficacy of HIV educators(Measured at 3-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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