Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pediatric Enhanced Surveillance Study (PESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elaine J. Abrams, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT02043769
First received: January 13, 2014
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The Pediatric Enhanced Surveillance Study (PESS) will describe children taking antiretroviral medications (ARVs) to treat human immunodeficiency virus (HIV) who are receiving care in public health care facilities in the Eastern Cape province of South Africa. The goal of the study is learn as much as possible about the treatment outcomes of these children, including whether they stay in care and reasons they do not, causes of death, how many experience treatment failure, and how many have biomedical and developmental complications. The study will enroll 400 children between the ages of 1 month and 12 years, who have HIV infection and are starting ARV treatment. All of the children will be part of the study for up to 2 years and will be asked to come back for study visits every 3 months, when they come for their routine care. The study will also look at the records of all children receiving care at the study health facilities and will enroll children already taking ARVs for a one-time visit.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Proportion of children alive and in care at 12 and 24 months after treatment initiation [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of children lost to follow-up [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of children with documented deaths [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of children who are virologically suppressed [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.


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.


Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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; and
  4. contact the caregiver by phone or through home visits for active follow-up for up to 24 months
  5. conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043769

Contacts
Contact: Elaine Abrams, MD 212-342-0505 eja1@columbia.edu
Contact: Chloe Teasdale, MPH 212-304-7920 ct116@columbia.edu

Locations
South Africa
Cecilia Makiwane Hospital Recruiting
East London, Amathole, South Africa
Contact: Anthony Mutiti, MD    +27 123600640    am3363@columbia.edu   
Frere Hospital Recruiting
East London, Amathole, South Africa
Contact: Anthony Mutiti, MD    +27 123600640    am3363@columbia.edu   
Dora Ngiza Hospital Recruiting
Port Elizabeth, Nelson Mandela Bay, South Africa
Contact: Anthony Mutiti, MD    +27 123600640    am3363@columbia.edu   
Kwazakhele Community Health Center Recruiting
Port Elizabeth, Nelson Mandela Bay, South Africa
Contact: Anthony Mutiti, MD    +27 123600640    am3363@columbia.edu   
Motherwell Community Health Center Recruiting
Port Elizabeth, Nelson Mandela Bay, South Africa
Contact: Anthony Mutiti, MD    +27 123600640    am3363@columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Elaine Abrams, MD ICAP-NY, Columbia University
  More Information

No publications provided

Responsible Party: Elaine J. Abrams, MD, Research Director, ICAP, Columbia University
ClinicalTrials.gov Identifier: NCT02043769     History of Changes
Other Study ID Numbers: AAAI1736, U2GPS001537, U262PS223540
Study First Received: January 13, 2014
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
South Africa
Eastern Cape
Child ARV
CLWHIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014