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PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life)

2018年4月30日 更新者:Geri Donenberg、University of Illinois at Chicago
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators will test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators.

研究概览

详细说明

High rates of mental illness, HIV/AIDS/STI, and incarceration among African Americans (AA) reflect significant health disparities, particularly among youth. Teens in juvenile justice are disproportionately AA, and compared to the general population, juvenile offenders (JO) report more risky sexual behavior, drug and alcohol use, and psychiatric disorders, and are more likely to test positive for STIs. Still, few empirically-supported, theoretically-driven programs exist to address their negative health outcomes. This proposal addresses these health disparities by testing an innovative and uniquely tailored HIV/AIDS/STI, mental health, and substance use program designed for and pilot tested with recently arrested 13 - 17 year-old urban males and females (85% African American, 14% Latino/a) released on probation. PHAT Life was derived from a carefully staged process that included an active, diverse, multi-disciplinary advisory board, a youth advisory board, focus groups, two pilot tests, extensive feedback, and a series of curriculum revisions over three years. The R34 established feasibility and acceptability, revealed positive youth and stakeholder feedback, and yielded good preliminary outcomes at 3-month follow-up (e.g., increased condom use) to justify an efficacy trial. This application proposes a 2-arm randomized controlled trial to test PHAT Life versus a health promotion program with recently arrested 13-17 year-old male and female, mostly ethnic minority JO (as representative of Cook County) on probation in Chicago. The investigators will use the procedures and methods established in the developmental study to recruit, enroll, assess, track, and intervene with teens. Investigators will randomly assign youth to PHAT Life (N=150) or a health promotion control group (N=150). The interventions will be delivered in single sex groups of 5 - 7 teens at Evening Reporting Centers. Assessments will occur at baseline, 6-, and 12-months post-treatment, and participants will be screened for three common STIs (Chlamydia, Gonorrhea, Trichamonas) at baseline and 12-month follow-up. All youth who test positive for an STI will receive single dose antibiotic treatment free of charge. An intent-to-treat analysis will be used to test and compare PHAT Life to the health promotion control group on adolescent risky sexual behavior, substance use, and theoretical mediators. This study answers a compelling need for innovative prevention programs that address the intersecting health disparities of mental illness and HIV/AIDS/STIs among youth in juvenile justice. Without intervention, these teens continue to engage in risk behaviors post-release, amplifying their own and their partner's risk for HIV/AIDS/STIs. The lasting effects on community well-being, individual employment prospects, and neighborhood health are profound, but effective programs can alter the negative developmental trajectories of this very high-risk population and begin to redress existing health disparities.

研究类型

介入性

注册 (实际的)

349

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60612
        • University of Illinois at Chicago

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 17年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • male or female gender
  • placed on probation following arrest
  • remanded to a probation program
  • 13-17 years old
  • both adolescent and parent are fluent English speakers
  • not a ward of the state (DCFS Ward).

Exclusion Criteria:

  • are unable to understand the consent/assent process
  • do not speak English, because instruments are normed for English speakers
  • do not assent; d) legal guardians do not consent to teens' participation
  • are not 13 -17 years old
  • are not on probation or remanded to a probation program
  • are Wards of the state (DCFS Ward)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 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:PHAT Life Intervention
PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for recently-arrested juvenile offenders on probation. The program will teach teens about HIV/AIDS, sexually transmitted infections, and safer decision-making. PHAT Life draws on social learning theory and a Social-Personal Framework to address individual and social mechanisms related to HIV-risk, including emotion regulation, peer norms, partner communication, relationship characteristics, and HIV/AIDS/STI and substance use knowledge, attitudes, and beliefs.
HIV Prevention behavioral health intervention
有源比较器:Health Promotion Control
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
Behavioral health intervention control

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
Change in HIV/STI Risk Behaviors at 6 and 12 months
大体时间:baseline, 6-months, and 12--months
AIDS Risk Behavior Assessment (ARBA) A computer-assisted structured interview of self-reported sexual behavior and drug use derived from five well-established measures. The outcomes include ever had sex, condom use, number of partners, sex while using drugs and/or alcohol.
baseline, 6-months, and 12--months

次要结果测量

结果测量
措施说明
大体时间
Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
Survey measuring knowledge regarding transmission routes, misconceptions about transmission, and risk-reduction strategies; attitudes and beliefs including peer norms, intentions to prevent HIV/AIDS/STI, attitudes towards preventive actions, and beliefs about condom use; as well as self-efficacy to prevent transmission, apply condoms, and negotiate with a partner.
Baseline, 6-months, and 12-months
Change in mental health symptoms at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The Youth Self Report (YSR) is a widely-used and validated measure of child behavior problems that generates raw and T-scores for internalizing and externalizing syndromes as well as narrow-band problems (e.g., delinquency, anxiety, depression).
Baseline, 6-months, and 12-months
Change in Partner Sexual Communication at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
Questionnaire in which participants indicate whether they ever talked to their romantic or dating partners and sexual partners about a list of sexual topics, how often they discussed them, and whether they talk was open and comfortable. Items were adapted from the Sexual Risk Behavior Questionnaire.
Baseline, 6-months, and 12-months
Change in Relationship dynamics at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The Sexual Relationship Power Scale (SRPS) measures perceptions of relationship control and decision-making dominance. It has good internal consistency and predictive and constructed validity.
Baseline, 6-months, and 12-months
Change in trauma symptoms and violence exposure at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The UCLA PTSD Index will measure exposure to trauma and violence.
Baseline, 6-months, and 12-months
Change in peer influences at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers.
Baseline, 6-months, and 12-months
Change in parental Influences at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
Baseline, 6-months, and 12-months
Change in parental communication at 6 and 12 months
大体时间:Baseline, 6-months, and 12-months
The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
Baseline, 6-months, and 12-months
Biological Measure of N. Gonorrhoeae Acquisition
大体时间:12-months
Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for N. gonorrhoeae and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition.
12-months
Biological Measure of C. Trachomatis Acquisition
大体时间:12-months
Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for C. trachomatis and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition.
12-months
Biological Measure of T. Vaginalis Acquisition
大体时间:12-months
Sexually transmitted infections will be measured using biological endpoint (yes/no) to evaluate intervention effects. Participants will be screened for T. vaginalis and treated if necessary at baseline. They will be tested again 12 months later to determine rate of STI acquisition.
12-months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Geri DONENBERG, PhD、University of Illinois at Chicago

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年6月15日

初级完成 (实际的)

2016年7月15日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2015年12月29日

首先提交符合 QC 标准的

2016年1月4日

首次发布 (估计)

2016年1月6日

研究记录更新

最后更新发布 (实际的)

2018年5月3日

上次提交的符合 QC 标准的更新

2018年4月30日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

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