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Randomized Controlled Trial of Social Network Targeting in Honduras

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ClinicalTrials.gov Identifier: NCT02694679
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : May 11, 2022
Sponsor:
Collaborators:
Inter-American Development Bank
University of California, San Diego
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Hypothermia Diarrhea Upper Respiratory Infection Omphalitis Behavioral: CBNH Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31195 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Arm Intervention/treatment
No Intervention: Random 0
The CBNH intervention will be delivered to 0% of population targeted households in the village.
Active Comparator: Random 5
The CBNH intervention will be delivered to a random 5% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 10
The CBNH intervention will be delivered to a random 10% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 20
The CBNH intervention will be delivered to a random 20% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 30
The CBNH intervention will be delivered to a random 30% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 50
The CBNH intervention will be delivered to a random 50% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 75
The CBNH intervention will be delivered to a random 75% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Active Comparator: Random 100
The CBNH intervention will be delivered to a random 100% of targeted households in the village.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

No Intervention: Friendship 0
CBNH 0% of population targeted
Experimental: Friendship 5
The CBNH intervention will be delivered to 5% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 10
The CBNH intervention will be delivered to 10% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 20
The CBNH intervention will be delivered to 20% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 30
The CBNH intervention will be delivered to 30% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 50
The CBNH intervention will be delivered to 50% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 75
The CBNH intervention will be delivered to 75% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Experimental: Friendship 100
The CBNH intervention will be delivered to 100% of households identified through friendship nomination.
Behavioral: CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.




Primary Outcome Measures :
  1. Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey). [ Time Frame: 24 Months ]
  2. Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey). [ Time Frame: 24 Months ]
  3. Percent of newborns with appropriate umbilical cord care (participant survey) [ Time Frame: 24 Months ]
  4. Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey) [ Time Frame: 24 Months ]
  5. Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey). [ Time Frame: 24 months ]
  6. Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey). [ Time Frame: 24 months ]
  7. Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey) [ Time Frame: 24 months ]
  8. Percent of children who were breastfed exclusively during first 6 months (participant survey) [ Time Frame: 24 Months ]
  9. Percentage of deliveries taking place in medical facilities (participant survey, medical records). [ Time Frame: 24 months ]
  10. Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records). [ Time Frame: 24 months ]
  11. Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records). [ Time Frame: 24 months ]
  12. Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey). [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Knowledge/attitudes about thermal care in newborns (Participant survey) [ Time Frame: 24 months ]
  2. Knowledge/attitudes about paternal involvement (Participant survey) [ Time Frame: 24 months ]
  3. Knowledge/attitudes about proper cord care (Participant survey) [ Time Frame: 24 months ]
  4. Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey) [ Time Frame: 24 months ]
  5. Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey) [ Time Frame: 24 months ]
  6. Knowledge about danger signs during pregnancy (Participant survey). [ Time Frame: 24 months ]
  7. Knowledge about danger signs for newborns (Participant survey). [ Time Frame: 24 months ]
  8. Knowledge/attitudes about facility-based births (Participant survey). [ Time Frame: 24 months ]
  9. Knowledge/attitudes about post-natal care for women (Participant survey). [ Time Frame: 24 months ]
  10. Knowledge/attitudes about post-natal care for newborns (Participant survey). [ Time Frame: 24 months ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: People who live or work in target villages, ages 12 and up -

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694679


Locations
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United States, Connecticut
Yale Institute for Network Science
New Haven, Connecticut, United States, 06520
Honduras
Community intervention
Copan Ruinas, Copan, Honduras
Sponsors and Collaborators
Yale University
Inter-American Development Bank
University of California, San Diego
Investigators
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Principal Investigator: Nicholas Christakis, MD, PhD Yale University
Publications:
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02694679    
Other Study ID Numbers: 1506016012
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022
Keywords provided by Yale University:
social networks, maternal and child health, global health
Additional relevant MeSH terms:
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Respiratory Tract Infections
Premature Birth
Diarrhea
Hypothermia
Signs and Symptoms, Digestive
Body Temperature Changes
Infections
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications