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临床试验/NCT02479659
NCT02479659已完成不适用

A Cluster Randomised Trial on the Impact of Integrating Early Infant HIV Diagnosis With the Expanded Programme on Immunization on Immunization and HIV Testing Rates in Rural Zambian Health Facilities

IDinsight0 个研究点目标入组 60 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Change in average monthly number of infant DBS HIV tests

研究概览

简要总结

This randomized evaluation measured the impact of two levels of support for the integration of infant and postpartum maternal HIV testing with routine immunization services in Southern Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose diphtheria, pertussis, and tetanus (DPT1) vaccines.

详细描述

This evaluation assessed two levels of support for the integration of early infant and maternal HIV testing with existing routine immunization services in rural health facilities in Southern Zambia with the aim of determining whether infant and postpartum maternal HIV testing rates would increase without harming immunization uptake. The evaluation randomized 60 health facilities to one of three study arms: 1) Control (status quo); 2) Simple Intervention; and 3) Comprehensive Intervention. The Simple Intervention included restocking of HIV test kits and reminding health facilities of existing HIV testing guidelines by government health officials. The Comprehensive Intervention included the Simple Intervention components, as well as community sensitization, hands-on operational support to integrate services and improve patient flow, and opt-out HIV testing for mothers and infants according to existing guidelines. The change in the average number of monthly HIV tests and immunizations (DPT1) between the intervention period and baseline were compared between treatment and control facilities.

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

性别
All
接受健康志愿者

入选标准

  • Note that this evaluation used administrative data - no participants were enrolled for the main part of this study. Participants were enrolled for the qualitative portions of the study.
  • Inclusion Criteria:
  • Mothers who had an infant within the past 18 months during the intervention period (Oct 2013 - Mar 2014)
  • Infants who were at least six weeks of age and under six months of age during the intervention period (Oct 2013 - Mar 2014)
  • Qualitative activities included facility staff and mothers and caregivers whose infants were due for their 6 week immunization during the intervention period.

排除标准

  • Mothers who did not have an infant within the past 18 months during the intervention period
  • Infants who were less than six weeks of age during the intervention period or greater than six months of age throughout out the intervention period.
  • Adults who were not mothers or caregivers with an infant due for his/her 6 week immunization during the intervention period were excluded from the qualitative activities.

结局指标

主要结局

Change in average monthly number of infant DBS HIV tests

时间窗: Baseline and 6 mos (endline)

Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of infant dried blood spot (DBS) HIV tests administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2012 - Sept 2013

Change in average monthly number of maternal postpartum HIV tests

时间窗: Baseline and 6 mos (endline)

Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of maternal postpartum HIV tests administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2013 - Sept 2013

Change in average monthly number of DPT1 doses administered

时间窗: Baseline and 6 mos (endline)

Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of first dose diphtheria, pertussis, and tetanus vaccine (DPT1) administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2012 - Sept 2013

次要结局

未报告次要终点

研究者

发起方
IDinsight
申办方类型
Other
责任方
Sponsor

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