Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,673
- 主要终点
- The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
研究概览
简要总结
The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.
A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First antenatal care visit
- •Able to provide informed consent and signed consent form
- •Minimum 18 years of age
- •Diagnosed HIV positive at antenatal care visit
- •Living in the catchment area of the health facility
排除标准
- •Age <18 years
- •No consent form signed
- •Being on ART at time of first antenatal care visit
研究组 & 干预措施
Point of Care Testing
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
干预措施: PIMA® for quantitative analysis of CD4-count (Device)
Point of Care Testing
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
干预措施: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin (Device)
Point of Care Testing
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
干预措施: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis (Device)
Laboratory Testing - Standard of care
Samples sent to the laboratory for analysis, (standard of care)
结局指标
主要结局
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
时间窗: Within 1 month
Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women
次要结局
- The proportion of pregnant women tested and treated for anemia(Within 1 month)
- Number of HIV infections in infants averted(1-3 months of age)
- Proportion of women at first ANC visit tested and treated for syphilis(Within 1 month)