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Pediatric Enhanced Surveillance Study (PESS)

2015. december 4. frissítette: Elaine J. Abrams, MD, Columbia University

Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

396

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Dél-Afrika
- Amathole
  - East London, Amathole, Dél-Afrika
    - Cecilia Makiwane Hospital
  - East London, Amathole, Dél-Afrika
    - Frere Hospital
- Nelson Mandela Bay
  - Port Elizabeth, Nelson Mandela Bay, Dél-Afrika
    - Dora Ngiza Hospital
  - Port Elizabeth, Nelson Mandela Bay, Dél-Afrika
    - Kwazakhele Community Health Center
  - Port Elizabeth, Nelson Mandela Bay, Dél-Afrika
    - Motherwell Community Health Center

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

1 hónap (Gyermek)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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: review routinely collected information; conduct questionnaires with caregiver and child; conduct additional assessments of child; contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.

Csoport / Kohorsz

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:

review routinely collected information;
conduct questionnaires with caregiver and child;
conduct additional assessments of child;
contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and
conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Proportion of children alive and in care at 12 and 24 months after treatment initiation Időkeret: Up to 24 months	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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services Időkeret: Up to 24 months	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
Proportion of children lost to follow-up Időkeret: Up to 24 months	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
Proportion of children with documented deaths Időkeret: Up to 24 months	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
Proportion of children who are virologically suppressed Időkeret: Up to 24 months	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
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts Időkeret: Up to 24 months	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
Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease Időkeret: Up to 24 months	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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Columbia University

Együttműködők

Centers for Disease Control and Prevention

Nyomozók

Kutatásvezető: Elaine Abrams, MD, ICAP-NY, Columbia University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2012. április 1.

Elsődleges befejezés (Tényleges)

2015. október 1.

A tanulmány befejezése (Tényleges)

2015. október 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2014. január 13.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2014. január 21.

Első közzététel (Becslés)

2014. január 23.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2015. december 7.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2015. december 4.

Utolsó ellenőrzés

2015. december 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

AAAI1736
U2GPS001537 (Az Egyesült Államok NIH támogatása/szerződése)
U262PS223540 (Egyéb támogatási/finanszírozási szám: MCAP)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .