Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 6
- 主要终点
- Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis
研究概览
简要总结
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
详细描述
At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).
HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.
The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 to 12 weeks of life
- •documented HIV exposure through seropositive maternal or infant HIV antibody test
- •with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment
排除标准
- •Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures
研究组 & 干预措施
DNA PCR HIV diagnostic test
SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing.
干预措施: DNA PCR HIV diagnostic test (Device)
Alere Q POC nucleic acid-based platform
POC test to provide same-day diagnosis
干预措施: Alere Q (Device)
结局指标
主要结局
Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis
时间窗: time of initial diagnosis through 12 months post diagnosis
次要结局
- Proportion of children starting ART who remain in care for 12 months following the initial diagnosis(time of initial diagnostic blood draw through 12 months post diagnosis)
- Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis(time of initial diagnosis through 6 months post diagnosis)