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临床试验/NCT01951794
NCT01951794已完成不适用

CIDRZ 1225 - Validation of a Community Survey Methodology for Measuring PMTCT Program Impact

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 827 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
827
试验地点
1
主要终点
HIV-free survival among HIV-exposed infants.

研究概览

简要总结

Validate a promising community survey methodology for evaluating the Prevention of Mother to Child Transmission (PMTCT) program effectiveness against a "gold standard" cohort design and to identify individual- and facility-level characteristics associated with HIV-free survival among HIV-exposed infants.

详细描述

The overarching aim of this study is to determine the accuracy and reliability of a household survey methodology to measure PMTCT program impact. If appropriately validated, this approach could be used to monitor program effectiveness across a wide range of settings, both as part of Demographic and Health Surveys (DHS) or in stand-alone evaluations.

Specific objectives

Objective 1: To validate the community survey methodology for measuring PMTCT program effectiveness. Across 42 communities in rural Lusaka Province, we will estimate HIV-free survival among HIV-exposed children using two methodologies at the community level: a survey approach and a "gold standard" cohort approach.

Hypothesis: HIV-free survival measurements from the two study components will demonstrate strong correlation and high inter-method agreement, thus confirming the validity of the community survey for PMTCT evaluation.

Objective 2: To identify individual- and facility-level characteristics associated with HIV-free survival among HIV-exposed infants. We will determine key characteristics associated with optimal PMTCT program effectiveness, thus providing an objective measurement of "best practices" in our setting.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
— 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

HIV-free survival among HIV-exposed infants.

时间窗: 18 months

Our primary outcome will be HIV-free survival at 18 months among HIV-exposed infants. HIV-free survival has been proposed as a more comprehensive measure of PMTCT program effectiveness than HIV infections alone, since health services may have a broader health impact outside of interrupted transmission. We have chosen the 18-month time point for several reasons. Because the vast majority of HIV-exposed infants will have stopped breastfeeding by this age, this will provide more complete ascertainment of mother-to-child transmission compared to earlier measurements. This time point has also been endorsed by the WHO as one of two priority outcomes for PMTCT impact evaluations. Since both methodologies will sample and recruit participants from within the community, our measures will be population-based (vs. facility-based).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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