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Pediatric Enhanced Surveillance Study (PESS)

2015年12月4日更新者：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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

396

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

南アフリカ
- Amathole
  - East London、Amathole、南アフリカ
    - Cecilia Makiwane Hospital
  - East London、Amathole、南アフリカ
    - Frere Hospital
- Nelson Mandela Bay
  - Port Elizabeth、Nelson Mandela Bay、南アフリカ
    - Dora Ngiza Hospital
  - Port Elizabeth、Nelson Mandela Bay、南アフリカ
    - Kwazakhele Community Health Center
  - Port Elizabeth、Nelson Mandela Bay、南アフリカ
    - Motherwell Community Health Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1ヶ月～12年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

グループ/コホート

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Proportion of children alive and in care at 12 and 24 months after treatment initiation 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Columbia University

協力者

Centers for Disease Control and Prevention

捜査官

主任研究者：Elaine Abrams, MD、ICAP-NY, Columbia University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年4月1日

一次修了 (実際)

2015年10月1日

研究の完了 (実際)

2015年10月1日

試験登録日

最初に提出

2014年1月13日

QC基準を満たした最初の提出物

2014年1月21日

最初の投稿 (見積もり)

2014年1月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年12月7日

QC基準を満たした最後の更新が送信されました

2015年12月4日

最終確認日

2015年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

AAAI1736
U2GPS001537 (米国 NIH グラント/契約)
U262PS223540 (その他の助成金/資金番号：MCAP)

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