HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Specificity of PoC HIV test
研究概览
简要总结
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
详细描述
This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.
Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.
The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary and informed consent of the mother for her own study participation (if applicable).
- •Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
- •Mothers/legal guardians ≥18 years of age.
- •Documented maternal HIV infection.
- •Willingness to consent to HIV testing for the child and herself (if applicable).
- •Willing to consent to active tracing including home tracing.
排除标准
- •Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- •Having delivered more than 48h ago
- •Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
- •Stillbirths
- •Infant requiring emergency care or born with severe malformation.
- •If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g)
- •Unlikely to comply with protocol as judged by the principal investigator or his designate
研究组 & 干预措施
In-vitro Diagnostics
All infants are recruited into the same arm.
干预措施: In-vitro Diagnostics (Other)
结局指标
主要结局
Specificity of PoC HIV test
时间窗: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Specificity of the PoC HIV test
Sensitivity of PoC HIV test
时间窗: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
Sensitivity of the PoC HIV test
次要结局
未报告次要终点
研究者
Michael Hoelscher
Prof Dr
Ludwig-Maximilians - University of Munich