- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02647710
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
Intervenção / Tratamento
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
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago
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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 |
|---|---|
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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.
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HIV Prevention behavioral health intervention
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Comparador Ativo: Health Promotion Control
A health promotion program focusing on nutrition, physical activity, substance use, and sexual health.
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Behavioral health intervention control
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in HIV/STI Risk Behaviors at 6 and 12 months
Prazo: baseline, 6-months, and 12--months
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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.
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baseline, 6-months, and 12--months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in HIV/AIDS/STI Knowledge, Attitudes, Beliefs, and Behavioral Skills at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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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.
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Baseline, 6-months, and 12-months
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Change in mental health symptoms at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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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).
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Baseline, 6-months, and 12-months
|
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Change in Partner Sexual Communication at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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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.
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Baseline, 6-months, and 12-months
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Change in Relationship dynamics at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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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.
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Baseline, 6-months, and 12-months
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Change in trauma symptoms and violence exposure at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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The UCLA PTSD Index will measure exposure to trauma and violence.
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Baseline, 6-months, and 12-months
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Change in peer influences at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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The Peer Convention Behavior Questionnaire will measure peer support of risky behavior, peer norms, and peer pressure and teens' association with prosocial peers.
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Baseline, 6-months, and 12-months
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Change in parental Influences at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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The Parenting Style Questionnaire (PSQ) measures parental supervision, monitoring, and permissiveness.
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Baseline, 6-months, and 12-months
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Change in parental communication at 6 and 12 months
Prazo: Baseline, 6-months, and 12-months
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The Parent-Child Sexual Communication Questionnaire assesses youths' perceived quality and quantity of risk-specific communication with their parents.
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Baseline, 6-months, and 12-months
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Biological Measure of N. Gonorrhoeae Acquisition
Prazo: 12-months
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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.
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12-months
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Biological Measure of C. Trachomatis Acquisition
Prazo: 12-months
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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.
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12-months
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Biological Measure of T. Vaginalis Acquisition
Prazo: 12-months
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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.
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12-months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Geri DONENBERG, PhD, University of Illinois at Chicago
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Donenberg GR, Emerson E, Mackesy-Amiti ME, Udell W. HIV-Risk Reduction with Juvenile Offenders on Probation. J Child Fam Stud. 2015 Jun 1;24(6):1672-1684. doi: 10.1007/s10826-014-9970-z.
- Udell W, Donenberg G, Emerson E. Parents matter in HIV-risk among probation youth. J Fam Psychol. 2011 Oct;25(5):785-9. doi: 10.1037/a0024987.
- Wilson HW, Berent E, Donenberg GR, Emerson EM, Rodriguez EM, Sandesara A. Trauma History and PTSD Symptoms in Juvenile Offenders on Probation. Vict Offender. 2013;8(4):10.1080/15564886.2013.835296. doi: 10.1080/15564886.2013.835296.
- Donenberg G, Emerson E, Kendall AD. HIV-risk reduction intervention for juvenile offenders on probation: The PHAT Life group randomized controlled trial. Health Psychol. 2018 Apr;37(4):364-374. doi: 10.1037/hea0000582. Epub 2018 Feb 1.
- Kendall AD, Emerson EM, Hartmann WE, Zinbarg RE, Donenberg GR. A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1053-1061. doi: 10.1016/j.jaac.2017.09.424. Epub 2017 Oct 5.
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
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
Outros números de identificação do estudo
- R01MD005861 (Concessão/Contrato do NIH dos EUA)
- 5R01MD005861-05 (Concessão/Contrato do NIH dos EUA)
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
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Duke UniversityGilead SciencesRecrutamentoPrevenção do HIV | Profilaxia pré-exposição ao HIV | Programa de Prevenção do HIV | Prevenção e cuidados com o HIV | Uso de profilaxia pré-exposição ao HIVEstados Unidos
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Federal University of São PauloGilead SciencesConcluído
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecrutamentoHIV | Teste de HIV | Ligação do HIV ao Cuidado | Tratamento de HIVEstados Unidos
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University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RecrutamentoPreparação | HIV | Prevenção do HIV | Absorção de PrEPEstados Unidos
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Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecrutamentoViabilidade | Prevenção do HIV | Absorção de PrEP | Aceitabilidade | Autoteste de HIV | Parceiros masculinos de mulheres pós-parto HIV negativasÁfrica do Sul
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement e outros colaboradoresDesconhecidoHIV | Crianças não infectadas pelo HIV | Crianças expostas ao HIVCamarões
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University of MinnesotaRetiradoInfecções por HIV | HIV/AIDS | HIV | AUXILIA | Aids/problema de HIV | AIDS e InfecçõesEstados Unidos
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University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRecrutamentoGravidez | HIV | Pós-parto | Adesão à terapia antirretroviral (TARV) para HIVBotsuana
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National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Ainda não está recrutando
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Jecho Biopharmaceuticals Co., Ltd.Ainda não está recrutando
Ensaios clínicos em PHAT Life Intervention
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University of Illinois at ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)ConcluídoHIV/AIDSEstados Unidos
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University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ConcluídoDor | Cuidado paliativo | Distúrbios da Retenção Cognitiva | Outra doença crônicaEstados Unidos
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Oregon Research Behavioral Intervention Strategies...University of Illinois at ChicagoConcluídoInfecção pelo HIV | Infecções sexualmente transmissíveis | ImplementaçãoEstados Unidos
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University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
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Ege Miray TopcuConcluídoAnsiedade | Cuidados de suporte liderados por enfermeiras | Intervenções de enfermagemTurquia (Türkiye)
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Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)ConcluídoDistúrbio de saúde mental | Uso de substânciasCanadá
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UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); Virginia Commonwealth UniversityRecrutamentoObesidade | Câncer | Atividade física | Dieta | Sobrevivência ao CâncerEstados Unidos
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Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
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Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos