Clinical trial NCT02043769: Pediatric Enhanced Surveillance Study
Official title: Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Keywords: South Africa
Eastern Cape
Child ARV
CLWHIV
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2014-01-23
Enrollment: 396
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of children alive and in care at 12 and 24 months after treatment initiation
timeFrame: Up to 24 months
Secondary outcomes:
measure: Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services
timeFrame: Up to 24 months
measure: Proportion of children lost to follow-up
timeFrame: Up to 24 months
measure: Proportion of children with documented deaths
timeFrame: Up to 24 months
measure: Proportion of children who are virologically suppressed
timeFrame: Up to 24 months
measure: Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts
timeFrame: Up to 24 months
measure: Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: East London
country: South Africa
facility: Cecilia Makiwane Hospital
state: Amathole
city: East London
country: South Africa
facility: Frere Hospital
state: Amathole
city: Port Elizabeth
country: South Africa
facility: Dora Ngiza Hospital
state: Nelson Mandela Bay
city: Port Elizabeth
country: South Africa
facility: Kwazakhele Community Health Center
state: Nelson Mandela Bay
city: Port Elizabeth
country: South Africa
facility: Motherwell Community Health Center
state: Nelson Mandela Bay
Study officials:
affiliation: ICAP-NY, Columbia University
name: Elaine Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References: