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临床试验/NCT02694679
NCT02694679已完成不适用

Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras

Yale University3 个研究点 分布在 2 个国家目标入组 31,195 人开始时间: 2015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
31,195
试验地点
3
主要终点
Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).

研究概览

简要总结

Social network targeting strategies can be used to improve the delivery and uptake of health interventions. We will enroll approximately 30,000 individuals into a randomized controlled trial of different targeting algorithms in order to explore how social network dynamics affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras. Our goal is to develop methods by which global health practitioners can exploit face-to-face social network interactions in order to maximize uptake of neonatal and infant health interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2 x 8 factorial design of different targeting algorithms.

详细描述

Honduras has one of the highest neonatal mortality rates in Latin America despite having made significant strides in reducing neonatal, infant, and child mortality in the last several decades. Although many neonatal and infant deaths can be prevented through provision of clinical care services, emerging evidence also suggests that a substantial reduction in neonatal and infant mortality can also be achieved with simple, low-cost interventions within family and community settings. This is particularly important in areas where functional community health facilities are not available. Family and community outreach programs can serve to educate families about beneficial home care practices.

In order to accelerate neonatal mortality reduction , there is an urgent need to develop innovative solutions that are not only effective, but also more easily implementable and more readily scalable. An important component of this challenge, which has hitherto not been effectively measured and understood with respect to neonatal mortality, is the "embeddedness" of individuals within social networks. Hence, through a large-scale randomized controlled trial (RCT) in rural Honduras, we will deploy and assess social network targeting algorithms in order to maximize diffusion and adoption of the "Changing behaviors to improve neonatal, child, and maternal health using communication and social networks at the community level intervention (CBNH)". The CBNH intervention is a household-level intervention package that targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management implemented by the Inter-American Development Bank (IADB) and their partners.

This RCT is aimed at discerning optimal methods for targeting delivery of the intervention to the population. Specifically we will (1) test what percentage of a community needs to be in a program to achieve social norms change around key neonatal care behaviors, and (2) test whether so-called nominated-friend-targeting, a method that targets individuals who are more highly connected in the network, is more effective than a control strategy. Our 2x8 factorial design will examine how large a subset of the population should be used as a "seed" group in order to maximize the chances of spread of the effect, and the efficiency with which such an intervention might be delivered in the future. To do this, we will assign each of the 176 study villages to either one of the two groups: 1)random assignment (active comparator), where "seed" individuals are chose at random or 2) friend-of-random assignment (experimental), where "seed" individuals are chosen on the basis of being named as a friend of a randomly selected individual. Each of the groups of villages will also be assigned to one of eight treatment percentages (0%, 5%, 10%, 20%, 30% 50%, 75%, 100%), where each represents the percent of targeted households in that village to receive the CBNH health intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

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

入选标准

  • People who live or work in target villages, ages 12 and up -

排除标准

  • People who do not live or work in the sample villages, and those who are prisoners, mentally impaired, or under age 12 years.

结局指标

主要结局

Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).

时间窗: 24 months

Percentage of deliveries taking place in medical facilities (participant survey, medical records).

时间窗: 24 months

Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).

时间窗: 24 months

Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).

时间窗: 24 Months

Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).

时间窗: 24 months

Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).

时间窗: 24 months

Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).

时间窗: 24 Months

Percent of newborns with appropriate umbilical cord care (participant survey)

时间窗: 24 Months

Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)

时间窗: 24 Months

Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).

时间窗: 24 months

Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)

时间窗: 24 months

Percent of children who were breastfed exclusively during first 6 months (participant survey)

时间窗: 24 Months

次要结局

  • Knowledge/attitudes about paternal involvement (Participant survey)(24 months)
  • Knowledge/attitudes about proper cord care (Participant survey)(24 months)
  • Knowledge/attitudes about post-natal care for women (Participant survey).(24 months)
  • Knowledge/attitudes about post-natal care for newborns (Participant survey).(24 months)
  • Knowledge/attitudes about thermal care in newborns (Participant survey)(24 months)
  • Knowledge about danger signs during pregnancy (Participant survey).(24 months)
  • Knowledge about danger signs for newborns (Participant survey).(24 months)
  • Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)(24 months)
  • Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)(24 months)
  • Knowledge/attitudes about facility-based births (Participant survey).(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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