Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,260
- 试验地点
- 1
- 主要终点
- Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
研究概览
简要总结
Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.
详细描述
In the first phase of the study, investigators will identify an optimal set of screening questions with acceptable sensitivity and false positive rate, based on the draft 11-question pilot tool. Using the identified questions, investigators will develop a composite screening tool and determine criteria that should be used for identifying children for testing with minimally acceptable sensitivity and false positive rates. In the second phase of the study, investigators will select optimal questions to create a composite screening tool and validate it in a similar study population. Investigators anticipate the accuracy of the tool will be much improved compared to the individual questions. Investigators will also assess the usability of the HIV Risk Screening Tool as measured by the time taken to administer the tool, and perceptions of its ease and simplicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;
- •Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;
- •Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).
排除标准
- •Children/adolescents aged 2 up to 18 years tested HIV positive
- •Children/adolescents ages 2 up to 18 years who require immediate hospitalization;
- •Children/adolescents ages 2 up to 18 years who refuse/are refused participation.
结局指标
主要结局
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
时间窗: Six weeks
Validation of combined questions assessed from Phase 1 in predicting HIV among OVC
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
时间窗: Four weeks
Sensitivity and specificity of eleven questions in predicting HIV among OVC
次要结局
- Usability of screening tool(Two weeks)