Evaluation of Haitian American Responsible Teens (HART)
The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. The comparison group will receive a nutrition intervention during the same time period. The primary goals of the evaluation are to determine the effectiveness of the HART program on delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing "abstinent" behavior and contraception use among those who were sexually experienced at baseline.
Over a five semester period, the programs will be implemented in 7 or more schools in the greater Boston area, with offerings in the fall, the spring and summer, among approximately 780 male and female Haitian students. The programs will recruit 9th & 10th grade Haitian students who will range in age from 13 to 19 years old. We will implement a randomized controlled trial in which each semester, students within schools will be stratified by gender and then randomly assigned to participate in the HART or the nutrition condition. Students will be recruited annually and enrolled until the summer of 2015. During the spring and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year three, 180 youth will be randomly assigned to condition each semester (360 youth total during Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120 youth will be randomly assigned in the second semester (300 youth total during Year 4). The number of times student-level randomization will occur and the number of groups formed will vary depending on the size of the 9th and 10th grade Haitian population served in each school.
研究概览
详细说明
This is an intervention with an evaluation component. In each school, students will have equal chance to participate in the sex education class or in the nutrition education class. Each participating school will have two (2) groups:
- The intervention group which will receive the HART sex education curriculum.
- The comparison group which will receive a nutrition education curriculum. There will be one PTSD awareness session for both groups.. This session will be provided by mental health professionals from the Haitian Mental Health Network. Each group will consist of about 13-15 student participants, with the groups meeting each week on specific week days. In addition to the ten-week curriculum, there will be sessions at the beginning and end of the cycle to administer the pre- and post-test questionnaires. The 12-week cycle will be repeated 2-3 times through the school year.
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria
- Haitian descent
- 13 to 19 years of age
- 9th and 10th grade
- Having signed assent and parental consent forms
- Willingness to participate in the pretest survey
Exclusion criteria
- Not of Haitian descent
- Age greater than 19 years
- Under 13 years of age
- Cognitive impairment
- Not having signed assent and parental consent forms
- Not willingness to participate in the pretest survey
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Intervention
The pregnancy prevention intervention to be tested is an adaptation of Becoming a Responsible Teen (BART), an evidence-based (proven to work by research) HIV prevention curriculum designed primarily for African American adolescents, ages 14-18, in community-based settings. The culturally-adapted version HART consists of nine sessions, lasting about 2 hours each, and includes interactive group discussions and role plays that are -performed by adolescents. Unlike BART, one PTSD awareness session has been added to address what happens to people who have been exposed to mental trauma and natural disasters. |
Skills based sexual education intervention plus PTSD awareness
|
无干预:Control or nutrition
Nutrition/fitness curriculum will teach students about ingredients in food that are good for the body and will keep it in good health
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified.
大体时间:One week after the intervention ended
|
This outcome is collected at one week post intervention using a quantitative self-administered survey.
Pre-test measures and key demographic data e.g.
age, gender and other covariates of prognostic significance that are found not to have a balanced distribution between the treatment and control are adjusted for using multivariate analysis to increase precision of treatment effect measure
|
One week after the intervention ended
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Three- cognitive constructs that are causally related with HIV knowledge within the "Information Motivation and Behavioral Skills" framework.. Our study includes : 3 measures of Personal motivation
大体时间:One week after the intervention ended
|
|
One week after the intervention ended
|
4 measures of Social motivation for preventive behavior
大体时间:One week after the intervention ended
|
A statistically significant posttest difference between the treatment and control in proportion of participants reporting not being embarrassed to buy, use, talk about condoms b) A statistically significant posttest difference between the treatment and control in Proportion of participant reporting condom effectiveness to prevent HIV c) A statistically significant posttest difference between the treatment and control in proportion reporting condom effectiveness to prevent pregnancy d) A statistically significant posttest difference between the treatment and control in proportion of participants reporting not believing that condom purchase is a regulation for youth under the age of 16.
|
One week after the intervention ended
|
4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.
大体时间:One week after the intervention ended
|
|
One week after the intervention ended
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- H30298
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
HART的临床试验
-
University of Alabama, TuscaloosaInnovations for Poverty Action招聘中