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Pediatric Enhanced Surveillance Study (PESS)

4 de dezembro de 2015 atualizado por: Elaine J. Abrams, MD, Columbia University

Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa

The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and children in South Africa to examine, clinical, immunologic, virologic, metabolic, psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive de-identified records review of all HIV-infected children enrolled in at the pediatric Wellness and ART clinics at the five study sites; and (2) a prospective cohort surveillance study with active consented enrollment with 12-24 months of follow-up. As part of the prospective cohort, the study will aim to collect outcomes on children lost to follow-up, including causes of death through review of death certificates in the clinical chart and through verbal autopsy reports. The study will provide insights into overall outcomes for the larger pediatric patient populations in the province and South Africa. This work is designed in collaboration with the provincial health authorities of the Eastern Cape Department of Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in support of the South African National ART Program for Children and aims to collect and analyze accurate, relevant and useful information that will be available on children seen at facilities. For the prospective cohort study, we will aim to enroll 400 children newly initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be actively followed for up to 24 months.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

South Africa is one of the countries hardest hit by the HIV/AIDS epidemic. There are more than 5 million people living with HIV in South Africa, including 280,000 children under the age of 15. Most HIV positive children acquire infection through mother-to-child transmission; in South Africa 29.3% of pregnant women attending antenatal services are HIV-infected. Furthermore, it is estimated that HIV is the cause of 35% of all deaths in children under five in South Africa. The South African government began a national rollout of HIV treatment for adults and children in 2003. As of 2007, an estimated 32,060 children under the age of 15 were receiving antiretroviral therapy (roughly 30% of those in need). There is an urgent need to obtain more comprehensive, in-depth, profiles of children enrolled in HIV care with a focus on documenting outcomes, particularly timing and causes of death, reasons for loss to follow-up, timing and frequency of treatment failure, adverse events, metabolic complications and psychosocial aspects of HIV disease.

Tipo de estudo

Observacional

Inscrição (Real)

396

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

  • África do Sul
    • Amathole
      • East London, Amathole, África do Sul
        • Cecilia Makiwane Hospital
      • East London, Amathole, África do Sul
        • Frere Hospital
    • Nelson Mandela Bay
      • Port Elizabeth, Nelson Mandela Bay, África do Sul
        • Dora Ngiza Hospital
      • Port Elizabeth, Nelson Mandela Bay, África do Sul
        • Kwazakhele Community Health Center
      • Port Elizabeth, Nelson Mandela Bay, África do Sul
        • Motherwell Community Health Center

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

1 mês a 12 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Human immunodeficiency virus (HIV)-infected children accessing HIV care and treatment services in the Eastern Cape of South Africa are the population of interest for the overall study.

  • Records review: All children with a record of care at the study facilities in the Wellness or antiretroviral (ART) clinic will form the study population.
  • Prospective cohort: ART-naïve children receiving care at participating sites who have reached eligibility for ART and consent to participate will form the study population. The sample for the study will be a subset of all children enrolled and receiving care at these public health care facilities.

Descrição

Inclusion Criteria:

  • The child is eligible for antiretroviral therapy (ART) initiation based on the South African Pediatric HIV guidelines.
  • The child has documentation of being HIV-infected by a positive HIV-Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), detectable HIV ribonucleic acid (RNA) viral load or a positive HIV antibody test (>18 months of age).
  • The child has no prior history of treatment with ART other than prophylaxis for preventing mother to child transmission (PMTCT) (may be initiating ART on day of enrollment in study).
  • The child is between 1 month and 12 years of age.
  • The parent or legal guardian provides written consent for participation.
  • The child provides assent for participation based on South African guidance for minors.

Exclusion Criteria:

  • Any subject not meeting all of the above inclusion criteria will not be eligible for the study.

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
Prospective Cohort

The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will:

  1. review routinely collected information;
  2. conduct questionnaires with caregiver and child;
  3. conduct additional assessments of child;
  4. contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and
  5. conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of children alive and in care at 12 and 24 months after treatment initiation
Prazo: Up to 24 months
We will measure the proportion of children alive and in care at 12 and 24 months after treatment initiation amount prospective cohort participants through routine clinical and study visits.
Up to 24 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services
Prazo: Up to 24 months
We will describe the proportion of the children enrolled in HIV care and treatment services at the study facilities who start treatment and are retained in care for 6, 12, 24, 36 and 48 months by reviewing clinical records at each facility.
Up to 24 months
Proportion of children lost to follow-up
Prazo: Up to 24 months
We will describe the proportion of children lost to follow-up after enrollment in care and in those starting treatment by reviewing clinical records of study participants.
Up to 24 months
Proportion of children with documented deaths
Prazo: Up to 24 months
We will describe proportion of children with documented deaths and causes of deaths and time to death (from enrollment) by reviewing clinical records of participants.
Up to 24 months
Proportion of children who are virologically suppressed
Prazo: Up to 24 months
We will measure the proportion of children who are virologically suppressed (< 400 copies/mL, per South African National Guidelines) at 12 and 24* months after treatment initiation in the prospective cohort through routine clinical and study visits.
Up to 24 months
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts
Prazo: Up to 24 months
We will measure the proportion of children, aged 2 to 5 years, on ART with CD4% <10% at 12, 24* months after treatment initiation and children older than 5 years on ART with CD4 count of < 100 at 12, 24 months after treatment initiation. These outcomes will be measured in participants of the prospective cohort who will give additional blood samples during routine clinical care.
Up to 24 months
Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease
Prazo: Up to 24 months
We will measure the proportion of children on ART progressing to WHO Stage 4 disease at 12 and 24 months after treatment initiation in the prospective cohort.
Up to 24 months

Colaboradores e Investigadores

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

Patrocinador

Columbia University

Colaboradores

Centers for Disease Control and Prevention

Investigadores

  • Investigador principal: Elaine Abrams, MD, ICAP-NY, Columbia University

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 abril de 2012

Conclusão Primária (Real)

1 de outubro de 2015

Conclusão do estudo (Real)

1 de outubro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

13 de janeiro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de janeiro de 2014

Primeira postagem (Estimativa)

23 de janeiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

7 de dezembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de dezembro de 2015

Última verificação

1 de dezembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AAAI1736
  • U2GPS001537 (Concessão/Contrato do NIH dos EUA)
  • U262PS223540 (Número de outro subsídio/financiamento: MCAP)

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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