Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02694679
Other study ID # 1506016012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date January 2020

Study information

Verified date August 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31195
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design


Intervention

Behavioral:
CBNH
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Locations

Country Name City State
Honduras Community intervention Copan Ruinas Copan
United States Yale Institute for Network Science New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University Inter-American Development Bank, University of California, San Diego

Countries where clinical trial is conducted

United States,  Honduras, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey). 24 Months
Primary Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey). 24 Months
Primary Percent of newborns with appropriate umbilical cord care (participant survey) 24 Months
Primary Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey) 24 Months
Primary Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey). 24 months
Primary Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey). 24 months
Primary Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey) 24 months
Primary Percent of children who were breastfed exclusively during first 6 months (participant survey) 24 Months
Primary Percentage of deliveries taking place in medical facilities (participant survey, medical records). 24 months
Primary Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records). 24 months
Primary Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records). 24 months
Primary Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey). 24 months
Secondary Knowledge/attitudes about thermal care in newborns (Participant survey) 24 months
Secondary Knowledge/attitudes about paternal involvement (Participant survey) 24 months
Secondary Knowledge/attitudes about proper cord care (Participant survey) 24 months
Secondary Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey) 24 months
Secondary Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey) 24 months
Secondary Knowledge about danger signs during pregnancy (Participant survey). 24 months
Secondary Knowledge about danger signs for newborns (Participant survey). 24 months
Secondary Knowledge/attitudes about facility-based births (Participant survey). 24 months
Secondary Knowledge/attitudes about post-natal care for women (Participant survey). 24 months
Secondary Knowledge/attitudes about post-natal care for newborns (Participant survey). 24 months
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3