Pediatric Enhanced Surveillance Study
Condition: Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Small amounts of additional blood will be drawn at the same time as routine blood draws and
      presents minimal risk to subjects (5cc of additional whole blood may be drawn from infants 1
      month to 12 months of age or less than 10 kg in weight; 5 to 10 cc of additional blood may be
      drawn from children older than 12 months of age or >10 kg in weight); these risks usually
      include bruising at the site of the venipuncture, transient pain and a negligible chance for
      infection. No more than three attempts to obtain the blood specimens will be allowed per
      patient per blood collection visit. If collection of a blood sample/s fails this may be
      attempted at the next scheduled visit.
    
Keywords: South Africa; Eastern Cape; Child ARV; CLWHIV