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临床试验/NCT01303575
NCT01303575已完成不适用

It's Your Game...Keep It Real for American Indian/Alaska Native Youth: Innovative Approaches to Prevent Teen Pregnancy Among Underserved Populations

The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2010年9月1日最近更新:
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
574
试验地点
4
主要终点
Delay onset of sexual activity

研究概览

简要总结

This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation of the It's Your Game…Keep It Real (IYG) intervention, relative to a comparison condition on sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14 years old). The original IYG program was designed for students in Houston middle schools to help students delay sexual initiation and if sexually active, use condoms and contraception. The present study will adapt the existing IYG program for an AI/AN youth cohort; the original IYG curriculum will be transferred into a web-based format and modified to incorporate additional culturally-relevant components. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity. Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex and psychosocial variables related to sexual risk-taking behavior. This project will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.

详细描述

The goal of this four year research project is to adapt and evaluate the effectiveness of an Internet-based HIV/STI, and pregnancy prevention curriculum for American Indian/Alaska Native (AI/AN) middle school-aged youth (12-14 years). This curriculum will be adapted from a successful, Internet-accessible, prevention program, It's Your Game…Keep it Real (IYG).

During year 1 (Fall 2010 through Spring 2011) of this project, the study team will test the usability of the existing IYG program, while performing an assessment of existing programs for cultural of the IYG intervention. In year 2 (beginning Fall 2011), the project team plans to initiate and complete development of the cultural-adapted IYG intervention for AI/AN youth (IYG-AI/AN). Starting in year 3 (Fall 2012), the study efficacy trial will commence to evaluate the effectiveness of IYG-AI/AN on sexual behaviors and psychosocial determinants of those behaviors among AI/AN youth in three regions (Alaska, the Pacific Northwest, including Idaho, Oregon, and Washington state, and Arizona) relative to a comparison condition. Recruitment sites will be middle schools and Boys and Girls Clubs (BGCs), identified through their affiliations with the Alaska Native Tribal Health Consortium (ANTHC), the Pacific Northwest Tribal Epicenter (the Epicenter) and the Inter Tribal Council of Arizona (ITCA). Randomization will occur regionally, at the site (schools and BGCs) level, to one of two conditions: IYG-AI/AN and a comparison condition. The comparison condition will consist of two web-based educational programs unrelated to sexual health. The IYG-AI/AN intervention will be compared against the comparison condition. The efficacy trial will continue for 16 months into year 4 (2013).

The primary hypothesis to be tested is: (1) youth who receive the IYG-AI/AN intervention will delay sexual activity relative to those who receive the comparison condition. The major dependent variable is the proportion of AI/AN youth initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the intervention on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as youth intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of AI/AN youth who are sexually active, occurrences of unprotected sexual intercourse and the number of sexual partners among these AI/AN youth.

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
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •American Indian or Alaska Native descent and/or tribal affiliation
  • •Youth ages 12-14 attending regular classes in regional middle schools or youth attending after-school programs and/or Boys and Girls Clubs
  • •English-speaking

排除标准

  • •Youth who are not of American Indian or Alaska Native descent
  • •Any physical or mental condition that would inhibit the ability to complete surveys and use computer programs, such as cognitive impairment, motor disorders (e.g. quadriplegia), learning difficulties or psychiatric/behavioral problems (e.g. autism, attention deficit disorder)
  • •Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study

研究组 & 干预措施

HIV, STI, and Pregnancy Prevention Curriculum

Experimental

干预措施: HIV, STI and Pregnancy Prevention Curriculum (Behavioral)

Control curricula: Science Education

Active Comparator

No sexual health elements

干预措施: Control Curricula (Behavioral)

结局指标

主要结局

Delay onset of sexual activity

时间窗: 16-months

delay onset of vaginal, oral or anal sex

Delay onset of sexual activity

时间窗: baseline

delay onset of vaginal, oral or anal sex

Delay onset of sexual activity

时间窗: 5-months

delay onset of vaginal, oral or anal sex

次要结局

  • Reduce alcohol/drug use(16-months)
  • Changes in perceived norms about sexual activity(16-months)
  • Decrease the number of sexual partners(16-months)
  • Condom use during sexual activity(16-months)
  • Increase sexual knowledge(16-months)
  • Changes in attitudes toward sexual activity(16-months)
  • Changes in perception of sexual beliefs among peers(16-months)
  • Changes in intentions to have/abstain from sex(16-months)
  • Reduce instances of sexual activity(16-months)
  • Contraceptive use while sexually active(5-months)
  • Prevalence of sexually transmitted infections(16-months)
  • Changes in sexual beliefs(16-months)
  • Increased self-efficacy for refusal skills(16-months)
  • Increased avoidance of risky situations(16-months)
  • Changes in reasons for or against having sex(16-months)
  • Increased self-efficacy for condom use(16-months)
  • Increased self-efficacy for refusal skills(baseline)
  • Increased self-efficacy for condom use(baseline)
  • Increased avoidance of risky situations(baseline)
  • Reduce alcohol/drug use(baseline)
  • Reduce instances of sexual activity(baseline)
  • Changes in perceived norms about sexual activity(baseline)
  • Decrease the number of sexual partners(baseline)
  • Changes in reasons for or against having sex(baseline)
  • Condom use during sexual activity(baseline)
  • Changes in intentions to have/abstain from sex(baseline)
  • Reduce alcohol/drug use(5-months)
  • Reduce instances of sexual activity(5-months)
  • Contraceptive use while sexually active(baseline)
  • Decrease the number of sexual partners(5-months)
  • Changes in sexual beliefs(baseline)
  • Prevalence of sexually transmitted infections(baseline)
  • Increase sexual knowledge(baseline)
  • Condom use during sexual activity(5-months)
  • Changes in attitudes toward sexual activity(baseline)
  • Changes in perception of sexual beliefs among peers(baseline)
  • Prevalence of sexually transmitted infections(5-months)
  • Increase sexual knowledge(5-months)
  • Changes in sexual beliefs(5-months)
  • Changes in attitudes toward sexual activity(5-months)
  • Changes in perception of sexual beliefs among peers(5-months)
  • Increased self-efficacy for refusal skills(5-months)
  • Increased self-efficacy for condom use(5-months)
  • Increased avoidance of risky situations(5-months)
  • Changes in perceived norms about sexual activity(5-months)
  • Changes in reasons for or against having sex(5-months)
  • Changes in intentions to have/abstain from sex(5-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ross Shegog

Associate Professor - School of Public Health

The University of Texas Health Science Center, Houston

研究点 (4)

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