ACTRN12616000734460已完成未知
Evaluating the impact of the Xpert (Registered Trademark) HIV-1 QUAL test in HIV-exposed infants in Myanmar and Papua New Guinea: A multinational multi-centre cluster-randomised controlled stepped-wedge intervention trial.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- Days 至 28 Days(—)
- 性别
- All
入选标准
- •i)Infants born to confirmed HIV-infected mothers (i.e. with documentation of prior counselling and HIV testing, with a confirmed positive HIV test result) and requiring HIV testing;
- •ii)Newborn infants within the first 28 days of life;
- •iii)Parent/caregiver residing, and planning to continue to reside, within the site-specific catchment area for the next six months;
- •iv)Parent/caregiver able and willing to give informed consent for enrolment of their infant in the study.
- •v)Parent/caregiver providing consent is aged 18 years or older
- •vi)Parent/caregiver is willing to provide reliable contact information (e.g. mobile phone number, home address, description of how to find their house if they live in a rural area), and consent to be contacted by a member of the research team in the community to remind them to re-attend for follow-up.
排除标准
- •i)Participant is enrolled in another research study which interferes with this study, or previously enrolled in this study;
- •ii)Parent/caregiver and/or participant has a medical or non-medical issue incapacitating participation in the research as decided by the local Principal Investigator.
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