Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 5
- 主要终点
- Proportion of children alive and in care at 12 and 24 months after treatment initiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Any subject not meeting all of the above inclusion criteria will not be eligible for the study.
结局指标
主要结局
Proportion of children alive and in care at 12 and 24 months after treatment initiation
时间窗: 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.
次要结局
- Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services(Up to 24 months)
- Proportion of children with documented deaths(Up to 24 months)
- Proportion of children lost to follow-up(Up to 24 months)
- Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts(Up to 24 months)
- Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease(Up to 24 months)
- Proportion of children who are virologically suppressed(Up to 24 months)
研究者
Elaine J. Abrams, MD
Research Director, ICAP
Columbia University