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Randomized Controlled Trial of Social Network Targeting in Honduras

Primary Purpose

Preterm Delivery, Hypothermia, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CBNH
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Delivery focused on measuring social networks, maternal and child health, global health

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Yale Institute for Network Science
  • Community intervention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Random 0

Random 5

Random 10

Random 20

Random 30

Random 50

Random 75

Random 100

Friendship 0

Friendship 5

Friendship 10

Friendship 20

Friendship 30

Friendship 50

Friendship 75

Friendship 100

Arm Description

The CBNH intervention will be delivered to 0% of population targeted households in the village.

The CBNH intervention will be delivered to a random 5% of targeted households in the village.

The CBNH intervention will be delivered to a random 10% of targeted households in the village.

The CBNH intervention will be delivered to a random 20% of targeted households in the village.

The CBNH intervention will be delivered to a random 30% of targeted households in the village.

The CBNH intervention will be delivered to a random 50% of targeted households in the village.

The CBNH intervention will be delivered to a random 75% of targeted households in the village.

The CBNH intervention will be delivered to a random 100% of targeted households in the village.

CBNH 0% of population targeted

The CBNH intervention will be delivered to 5% of households identified through friendship nomination.

The CBNH intervention will be delivered to 10% of households identified through friendship nomination.

The CBNH intervention will be delivered to 20% of households identified through friendship nomination.

The CBNH intervention will be delivered to 30% of households identified through friendship nomination.

The CBNH intervention will be delivered to 50% of households identified through friendship nomination.

The CBNH intervention will be delivered to 75% of households identified through friendship nomination.

The CBNH intervention will be delivered to 100% of households identified through friendship nomination.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2016
Last Updated
August 4, 2023
Sponsor
Yale University
Collaborators
Inter-American Development Bank, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02694679
Brief Title
Randomized Controlled Trial of Social Network Targeting in Honduras
Official Title
Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Inter-American Development Bank, University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Hypothermia, Diarrhea, Upper Respiratory Infection, Omphalitis
Keywords
social networks, maternal and child health, global health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Random 0
Arm Type
No Intervention
Arm Description
The CBNH intervention will be delivered to 0% of population targeted households in the village.
Arm Title
Random 5
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 5% of targeted households in the village.
Arm Title
Random 10
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 10% of targeted households in the village.
Arm Title
Random 20
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 20% of targeted households in the village.
Arm Title
Random 30
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 30% of targeted households in the village.
Arm Title
Random 50
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 50% of targeted households in the village.
Arm Title
Random 75
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 75% of targeted households in the village.
Arm Title
Random 100
Arm Type
Active Comparator
Arm Description
The CBNH intervention will be delivered to a random 100% of targeted households in the village.
Arm Title
Friendship 0
Arm Type
No Intervention
Arm Description
CBNH 0% of population targeted
Arm Title
Friendship 5
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 5% of households identified through friendship nomination.
Arm Title
Friendship 10
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 10% of households identified through friendship nomination.
Arm Title
Friendship 20
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 20% of households identified through friendship nomination.
Arm Title
Friendship 30
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 30% of households identified through friendship nomination.
Arm Title
Friendship 50
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 50% of households identified through friendship nomination.
Arm Title
Friendship 75
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 75% of households identified through friendship nomination.
Arm Title
Friendship 100
Arm Type
Experimental
Arm Description
The CBNH intervention will be delivered to 100% of households identified through friendship nomination.
Intervention Type
Behavioral
Intervention Name(s)
CBNH
Intervention Description
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.
Primary Outcome Measure Information:
Title
Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).
Time Frame
24 Months
Title
Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).
Time Frame
24 Months
Title
Percent of newborns with appropriate umbilical cord care (participant survey)
Time Frame
24 Months
Title
Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)
Time Frame
24 Months
Title
Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).
Time Frame
24 months
Title
Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).
Time Frame
24 months
Title
Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)
Time Frame
24 months
Title
Percent of children who were breastfed exclusively during first 6 months (participant survey)
Time Frame
24 Months
Title
Percentage of deliveries taking place in medical facilities (participant survey, medical records).
Time Frame
24 months
Title
Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).
Time Frame
24 months
Title
Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).
Time Frame
24 months
Title
Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Knowledge/attitudes about thermal care in newborns (Participant survey)
Time Frame
24 months
Title
Knowledge/attitudes about paternal involvement (Participant survey)
Time Frame
24 months
Title
Knowledge/attitudes about proper cord care (Participant survey)
Time Frame
24 months
Title
Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)
Time Frame
24 months
Title
Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)
Time Frame
24 months
Title
Knowledge about danger signs during pregnancy (Participant survey).
Time Frame
24 months
Title
Knowledge about danger signs for newborns (Participant survey).
Time Frame
24 months
Title
Knowledge/attitudes about facility-based births (Participant survey).
Time Frame
24 months
Title
Knowledge/attitudes about post-natal care for women (Participant survey).
Time Frame
24 months
Title
Knowledge/attitudes about post-natal care for newborns (Participant survey).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Christakis, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Institute for Network Science
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Community intervention
City
Copan Ruinas
State/Province
Copan
Country
Honduras

12. IPD Sharing Statement

Citations:
PubMed Identifier
28289044
Citation
Shakya HB, Stafford D, Hughes DA, Keegan T, Negron R, Broome J, McKnight M, Nicoll L, Nelson J, Iriarte E, Ordonez M, Airoldi E, Fowler JH, Christakis NA. Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras. BMJ Open. 2017 Mar 13;7(3):e012996. doi: 10.1136/bmjopen-2016-012996.
Results Reference
background

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Randomized Controlled Trial of Social Network Targeting in Honduras

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