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Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

27 de fevereiro de 2017 atualizado por: University of North Carolina, Chapel Hill

Connect to Protect (C2P) Partnerships for Youth Prevention Interventions: Phase II

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.

This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.

During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:

Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.

Tipo de estudo

Observacional

Inscrição (Real)

16706

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

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90054
        • Childrens Hospital of Los Angeles
      • San Diego, California, Estados Unidos, 92103
        • UCSD Mother, Child & Adolescent HIV Program
      • San Francisco, California, Estados Unidos, 94143
        • Univ of Califormia at San Francisco
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Children's Hospital National Medical Center
    • Florida
      • Ft. Lauderdale, Florida, Estados Unidos, 33301
        • Children's Diag. and Treatment Center
      • Miami, Florida, Estados Unidos, 33101
        • University of Miami
      • Tampa, Florida, Estados Unidos, 33606
        • USF Peds Div. of Infectious Disease
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Childrens' Hospital of Boston
    • New York
      • Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center, Adolescent AIDS Program
      • New York, New York, Estados Unidos, 10128
        • Mount Sinai Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Children's Hopsital of Philadelphia
  • Porto Rico
      • San Juan, Porto Rico, 00936
        • University Pediatric Hospital

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

12 anos a 24 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

HIV infected youth, ages 12 through 24 years old, in treatment/care at each of the 15 ATN sites will be interviewed using ACASI technology to reveal possible venues where youth at high risk for acquiring the HIV may be found. Individuals approached at 3-5 of these identified venues who appear to be 12 through 24 years will be offered a brief venue interview. Anonymous HIV serosurvey (ACASI and HIV-Ab assay) will be administered to 20-30 young women at 2-3 identified high-risk venues, and 20-30 young men at 2-3 identified high-risk venues, who provide verbal confirmation of being 12 through 24 years old, and whose HIV status is unknown to the site staff.

Descrição

Inclusion Criteria:

Index Subjects:

  • Documented HIV-infection
  • Acquisition of HIV after age 9 years
  • Verbal confirmation of 12-24 years of age
  • Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
  • Ability to understand and willingness to provide informed consent/assent

BVI subjects:

  • Youths who appear to be 12-24 years old

HIV Serosurvey subjects at the venues:

  • Verbal confirmation of 12-24 years of age
  • Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
  • Ability to understand and willingness to provide informed consent/assent

Exclusion Criteria:

  • Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
  • Visibly intoxicated or under the influence of psychoactive agents
  • Clinically presents as acutely ill

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

Coortes e Intervenções

Grupo / Coorte
HIV Infected Youth in Treatment/Care
HIV infected youth in treatment/care will be interviewed using Audio Computer-Assisted Self-Administered Interview ACASI technology to reveal possible venues where youth at high risk for acquiring the disease may be found (N = 20-30 individuals per ATN site).
BVI Individuals
Additional data will be gathered on potential recruitment venues by administering a brief venue interview (BVI) to individuals who appear to be between 12 and 24 years old (N = unlimited individuals during 3-5 assessment periods per venue each lasting 5 hours).
HIV Serosurvey Individuals
HIV Serosurvey Individuals Anonymous structured interview using ACASI technology and an anonymous HIV antibody assay will be administered to 20-30 young women at 2-3 targeted locations and 20-30 young men at 2-3 targeted locations whose HIV status is unknown (N = 160-360 individuals per ATN site)..

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ascertain specific community venues where at-risk youth can be recruited for interventions within the high-risk areas identified in the first Phase of the study
Prazo: One time assessment at 10 months
The outcome measure will be assessed using results from: (a) Phase I mapping; (b) Phase II interviews with HIV-infected youth; and (c) Phase II Brief Venue Interviews (BVIs). Input from community partners and ethnographic procedures will add critical information.
One time assessment at 10 months
Describe HIV risk behaviors of adolescents and young adults recruited from targeted venues
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Describe social networks of adolescents and young adults recruited from targeted venues
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Describe HIV seroprevalence of adolescents and young adults recruited from targeted venues
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting HIV serosurveys at each venue identified with youth whose HIV status is unknown.
One time assessment at 10 months
Assess the characteristics of the community-researcher partnerships
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months
Assess quality of the community-researcher partnerships
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months
Assess outcomes of the community-researcher partnerships
Prazo: One time assessment at 10 months
The outcome measure will be assessed by conducting interviews with C2P staff and their community partners. Questionnaires will be completed by both parties and detailed documentation kept.
One time assessment at 10 months

Colaboradores e Investigadores

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

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Investigadores

  • Investigador principal: Donna Futterman, MD, Montefiore Medical Center
  • Investigador principal: Sue Ellen Abdalian, MD, Tulane Medical Center
  • Cadeira de estudo: Jonathan Ellen, MD, Johns Hopkins Medical Center
  • Investigador principal: Ligia Peralta, MD, Division of Adolescent & Young Adult Medicine University of MD, Medical School
  • Investigador principal: Marvin Belzer, MD, Childrens Hosp of Los Angeles, Division of Adolescent Medicine
  • Investigador principal: Bret Rudy, MD, Children's Hospital of Philadelphia
  • Investigador principal: Larry D'Angelo, MD, Children's National Research Institute
  • Investigador principal: Cathryn Samples, MD, Boston Children's Hospital
  • Investigador principal: Lisa Henry-Reid, MD, John H. Stroger Jr. Hospital and the CORE Center
  • Investigador principal: Ana Puga, MD, Children's Diag. and Treatment Ctr of Ft. Lauderdale, FL
  • Investigador principal: Lawrence Friedman, MD, University of Miami, School of Medicine, Div of Adolescent Medicine
  • Investigador principal: Patricia Emmanuel, MD, University of South Florida, Peds Div of Infectious Disease
  • Investigador principal: Linda Levin, MD, Mount Sinai Adolescent Health Center
  • Investigador principal: Irma Febo, MD, University of Puerto Rico Medical Sciences Campus
  • Investigador principal: Stephen A Spector, MD, UCSD Mother, Child, & Adolescent HIV Program
  • Investigador principal: Rolando M Viani, MD, UCSD Mother, Child, & Adolescent HIV Program
  • Investigador principal: Barbara Moscicki, MD, UCSF, Division of Adoles. Med
  • Investigador principal: Coco Auerswald, MD, UCSF, Division of Adoles. Med

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.

Links úteis

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

1 de setembro de 2003

Conclusão Primária (Real)

1 de outubro de 2010

Conclusão do estudo (Real)

1 de outubro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

15 de fevereiro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de fevereiro de 2005

Primeira postagem (Estimativa)

16 de fevereiro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de março de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de fevereiro de 2017

Última verificação

1 de julho de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ATN 016b

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 .

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