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临床试验/NCT01774136
NCT01774136已完成不适用

The Effectiveness of an HIV-adapted IMCI Training and Supervision Programme of Community Caregivers to Support Interventions That Will Reduce MTCT and Improve Delivery of Other Essential Newborn and Child Survival Interventions

University of KwaZulu1 个研究点 分布在 1 个国家目标入组 1,342 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,342
试验地点
1
主要终点
Prevalence of antenatal booking before 20 weeks gestation

研究概览

简要总结

This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within households in rural communities in Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. The primary objectives of the proposed evaluation are to measure the effect of the intervention on key outcomes, including early uptake of antenatal care, facility based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR testing in infants at 6 weeks. We will also examine the effects of the intervention on immunization uptake up to 12 months and knowledge and practices of CCGs and mothers pertaining to maternal, newborn and child health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Community caregivers
  • CCGs who work in Ugu District
  • age 18 years or older
  • with grade 9 education or greater
  • Mothers age 18 years and older who delivered a live-born infant within the prior 12 months
  • Reside in households served by participating CCGs.

排除标准

  • 未提供

研究组 & 干预措施

Enhanced HIV and MCH training for CHW

Experimental

The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs.

干预措施: Enhanced HIV and MCH training for CHW (Behavioral)

Standard of Care

No Intervention

结局指标

主要结局

Prevalence of antenatal booking before 20 weeks gestation

时间窗: 1 year

Prevalence of presentation for post-natal care within 7 days of delivery

时间窗: 1 year

Prevalence of exclusive breast-feeding practice at 14 weeks

时间窗: 1 year

Coverage of HIV PCR testing at 6 weeks

时间窗: 1 year

次要结局

  • Proportion of infants born to HIV-positive mothers who received ARV prophylaxis following birth (including during breastfeeding where appropriate)(1 year)
  • Knowledge and practices of mothers in the community regarding: infant feeding, HIV, availability of interventions to reduce HIV transmission, newborn care practices and recognition of serious illness in children and management of childhood illnesses(1 year)
  • Knowledge and practices of CCGs with regards to: HIV-specific interventions to improve maternal health, reduce HIV transmission and improve child survival(1 year)
  • Proportion of women who attended for antenatal care at least 4 times in pregnancy(1 year)
  • Proportion of deliveries by skilled birth attendant at a health facility(1 year)
  • Proportion of age-eligible infants who received recommended immunizations at 6, 10, and 14 weeks and 9 and 12 months(1 year)
  • Proportion of children whose growth was monitored by CCG at home(1 year)
  • Prevalence of exclusive breast-feeding practice at 6 months(1 year)
  • Proportion of women without known HIV-positive status who received HIV test in pregnancy(1 year)
  • Proportion of women without known HIV-positive status who received HIV test result in pregnancy(1 year)
  • Proportion of HIV-positive women who received CD4 test results(1 year)
  • Proportion of HIV-positive women who received ARV prophylaxis in pregnancy and during delivery(1 year)

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jennifer Reddy

Director

University of KwaZulu

研究点 (1)

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