Pediatric Enhanced Surveillance Study

NCT ID: NCT02043769

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 396 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Elaine J. Abrams, MD

Research Director, ICAP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

ICAP-NY, Columbia University

Locations

Cecilia Makiwane Hospital

East London, Amathole, South Africa

Frere Hospital

East London, Amathole, South Africa

Dora Ngiza Hospital

Port Elizabeth, Nelson Mandela Bay, South Africa

Kwazakhele Community Health Center

Port Elizabeth, Nelson Mandela Bay, South Africa

Motherwell Community Health Center

Port Elizabeth, Nelson Mandela Bay, South Africa

Countries

South Africa

Other Identifiers

U2GPS001537

Identifier Type: NIH

Identifier Source: secondary_id

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U262PS223540

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAI1736

Identifier Type: -

Identifier Source: org_study_id