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

30 de abril de 2018 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

349

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois at Chicago

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

13 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Comparador Ativo: Health Promotion Control
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
Behavioral health intervention control

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in HIV/STI Risk Behaviors at 6 and 12 months
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Geri DONENBERG, PhD, University of Illinois at Chicago

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de junho de 2010

Conclusão Primária (Real)

15 de julho de 2016

Conclusão do estudo (Real)

31 de dezembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

29 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de janeiro de 2016

Primeira postagem (Estimativa)

6 de janeiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de abril de 2018

Última verificação

1 de abril de 2018

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em HIV

Ensaios clínicos em PHAT Life Intervention

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