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临床试验/NCT02647710
NCT02647710已完成不适用

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

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2010年6月15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
349
试验地点
2
主要终点
Change in HIV/STI Risk Behaviors at 6 and 12 months

研究概览

简要总结

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.

详细描述

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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)

研究组 & 干预措施

PHAT Life Intervention

Experimental

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.

干预措施: PHAT Life Intervention (Behavioral)

Health Promotion Control

Active Comparator

A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.

干预措施: Health Promotion Control (Behavioral)

结局指标

主要结局

Change in HIV/STI Risk Behaviors at 6 and 12 months

时间窗: 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.

次要结局

  • Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in mental health symptoms at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in Partner Sexual Communication at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in Relationship dynamics at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in trauma symptoms and violence exposure at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in peer influences at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in parental Influences at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Change in parental communication at 6 and 12 months(Baseline, 6-months, and 12-months)
  • Biological Measure of N. Gonorrhoeae Acquisition(12-months)
  • Biological Measure of C. Trachomatis Acquisition(12-months)
  • Biological Measure of T. Vaginalis Acquisition(12-months)

研究者

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

Geri Donenberg

Associate Dean of Research, Professor

University of Illinois at Chicago

研究点 (2)

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