- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694679
Randomized Controlled Trial of Social Network Targeting in Honduras
Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Copan
-
Copan Ruinas, Copan, Honduras
- Community intervention
-
-
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale Institute for Network Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).
Time Frame: 24 Months
|
24 Months
|
Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).
Time Frame: 24 Months
|
24 Months
|
Percent of newborns with appropriate umbilical cord care (participant survey)
Time Frame: 24 Months
|
24 Months
|
Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)
Time Frame: 24 Months
|
24 Months
|
Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).
Time Frame: 24 months
|
24 months
|
Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).
Time Frame: 24 months
|
24 months
|
Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)
Time Frame: 24 months
|
24 months
|
Percent of children who were breastfed exclusively during first 6 months (participant survey)
Time Frame: 24 Months
|
24 Months
|
Percentage of deliveries taking place in medical facilities (participant survey, medical records).
Time Frame: 24 months
|
24 months
|
Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).
Time Frame: 24 months
|
24 months
|
Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).
Time Frame: 24 months
|
24 months
|
Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge/attitudes about thermal care in newborns (Participant survey)
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about paternal involvement (Participant survey)
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about proper cord care (Participant survey)
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)
Time Frame: 24 months
|
24 months
|
Knowledge about danger signs during pregnancy (Participant survey).
Time Frame: 24 months
|
24 months
|
Knowledge about danger signs for newborns (Participant survey).
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about facility-based births (Participant survey).
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about post-natal care for women (Participant survey).
Time Frame: 24 months
|
24 months
|
Knowledge/attitudes about post-natal care for newborns (Participant survey).
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicholas Christakis, MD, PhD, Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Diseases
- Signs and Symptoms, Digestive
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Body Temperature Changes
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Diarrhea
- Premature Birth
- Respiratory Tract Infections
- Hypothermia
Other Study ID Numbers
- 1506016012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diarrhea
-
Aboca Spa Societa' AgricolaUnknownDiarrhea | Diarrhea, Infantile | Chronic Diarrhea | Acute Diarrhea
-
Napo Pharmaceuticals, Inc.Active, not recruitingAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
-
South Shore HospitalWithdrawnAntibiotic Associated Diarrhea | Clostridium Difficile Associated Diarrhea
-
Hospital San BartolomeInstituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo...Unknown
-
Cosmo Technologies LtdBausch Health Americas, Inc.CompletedTraveler's DiarrheaGuatemala, Mexico
-
Sana'a UniversityCompleted
-
PATHUniversity of Maryland; Center for Vaccine Development - MaliCompleted
-
Johns Hopkins Bloomberg School of Public HealthNaval Medical Research CenterCompletedTravelers' DiarrheaUnited States
-
Intercell USA, Inc.CompletedTraveler's DiarrheaUnited States
-
Augusta UniversityNRS Medical College, Kolkata, West Bengal, India; School of Tropical Medicine...Terminated