Pediatric Enhanced Surveillance Study

NCT02043769 | Completed

• 3 other identifiers: AAAI1736U2GPS001537U262PS223540
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

South Africa; Eastern Cape; Child ARV; CLWHIV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services

  Up to 24 months

• Proportion of children lost to follow-up

  Up to 24 months

• Proportion of children with documented deaths

  Up to 24 months

• Proportion of children who are virologically suppressed

  Up to 24 months

• Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts

  Up to 24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (5)

Cecilia Makiwane Hospital

East London, Amathole, South Africa

Location

Frere Hospital

East London, Amathole, South Africa

Location

Dora Ngiza Hospital

Port Elizabeth, Nelson Mandela Bay, South Africa

Location

Kwazakhele Community Health Center

Port Elizabeth, Nelson Mandela Bay, South Africa

Location

Motherwell Community Health Center

Port Elizabeth, Nelson Mandela Bay, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Elaine Abrams, MD

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, ICAP

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 23, 2014
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

ZA (5)