Pediatric Enhanced Surveillance Study

Human Immunodeficiency Virus (HIV) Clinical Trial

— PESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043769
• Other study ID #: AAAI1736
• Secondary ID: U2GPS001537U262P
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: December 4, 2015
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome (AIDS)
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
South Africa	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

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children alive and in care at 12 and 24 months after treatment initiation	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	No
Secondary	Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services	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	No
Secondary	Proportion of children lost to follow-up	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	No
Secondary	Proportion of children with documented deaths	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	No
Secondary	Proportion of children who are virologically suppressed	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	No
Secondary	Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts	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	No
Secondary	Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease	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	No