## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 1506016012
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2020-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-06

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2016-02-29
**Type:** ESTIMATED
**Study First Submit Date:** 2016-02-24
**Study First Submit QC Date:** 2016-02-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Inter-American Development Bank

**Class:** OTHER

**Name:** University of California, San Diego

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Preterm Delivery

- Hypothermia

- Diarrhea

- Upper Respiratory Infection

- Omphalitis

**Keywords:**

- social networks, maternal and child health, global health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 31195

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Random 0

**Type:** NO_INTERVENTION

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 5

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 10

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 20

**Type:** ACTIVE_COMPARATOR

#### Arm Group 5

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 30

**Type:** ACTIVE_COMPARATOR

#### Arm Group 6

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 50

**Type:** ACTIVE_COMPARATOR

#### Arm Group 7

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 75

**Type:** ACTIVE_COMPARATOR

#### Arm Group 8

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Random 100

**Type:** ACTIVE_COMPARATOR

#### Arm Group 9

**Description:** CBNH 0% of population targeted

**Label:** Friendship 0

**Type:** NO_INTERVENTION

#### Arm Group 10

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 5

**Type:** EXPERIMENTAL

#### Arm Group 11

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 10

**Type:** EXPERIMENTAL

#### Arm Group 12

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 20

**Type:** EXPERIMENTAL

#### Arm Group 13

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 30

**Type:** EXPERIMENTAL

#### Arm Group 14

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 50

**Type:** EXPERIMENTAL

#### Arm Group 15

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 75

**Type:** EXPERIMENTAL

#### Arm Group 16

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

**Intervention Names:**

- Behavioral: CBNH

**Label:** Friendship 100

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Friendship 10

- Friendship 100

- Friendship 20

- Friendship 30

- Friendship 5

- Friendship 50

- Friendship 75

- Random 10

- Random 100

- Random 20

- Random 30

- Random 5

- Random 50

- Random 75

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

**Name:** CBNH

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 24 Months

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

**Time Frame:** 24 Months

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

**Time Frame:** 24 Months

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

**Time Frame:** 24 Months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 Months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 months

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

**Time Frame:** 24 months

#### Secondary Outcomes

**Measure:** Knowledge/attitudes about thermal care in newborns (Participant survey)

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about paternal involvement (Participant survey)

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about proper cord care (Participant survey)

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)

**Time Frame:** 24 months

**Measure:** Knowledge about danger signs during pregnancy (Participant survey).

**Time Frame:** 24 months

**Measure:** Knowledge about danger signs for newborns (Participant survey).

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about facility-based births (Participant survey).

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about post-natal care for women (Participant survey).

**Time Frame:** 24 months

**Measure:** Knowledge/attitudes about post-natal care for newborns (Participant survey).

**Time Frame:** 24 months

### Eligibility Module

**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.

-

**Healthy Volunteers:** True

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Haven

**Country:** United States

**Facility:** Yale Institute for Network Science

**State:** Connecticut

**Zip:** 06520

**Location 2:**

**City:** Copan Ruinas

**Country:** Honduras

**Facility:** Community intervention

**State:** Copan

#### Overall Officials

**Official 1:**

**Affiliation:** Yale University

**Name:** Nicholas Christakis, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 28289044

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000001832

- Term: Body Temperature Changes

- ID: D000007239

- Term: Infections

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10085

- Name: Hypothermia

- Relevance: HIGH

- As Found: Hypothermia

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm Delivery

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: HIGH

- As Found: Upper Respiratory Infection

- ID: M7159

- Name: Diarrhea

- Relevance: HIGH

- As Found: Diarrhea

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M5111

- Name: Body Temperature Changes

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000047928

- Term: Premature Birth

- ID: D000003967

- Term: Diarrhea

- ID: D000007035

- Term: Hypothermia

### Misc Info Module

- Version Holder: 2024-05-24
