<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672580</url>
  </required_header>
  <id_info>
    <org_study_id>Lempira_Phase2</org_study_id>
    <nct_id>NCT01672580</nct_id>
  </id_info>
  <brief_title>Social Network Interventions in Rural Honduras</brief_title>
  <official_title>Diffusion of Health Interventions Across Social Networks in Honduran Villages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will examine the spread of health interventions with a randomized control trial&#xD;
      design by introducing public health interventions in 32 villages in the Honduran Department&#xD;
      of Lempira. Based on identified public health needs in the region, namely improved drinking&#xD;
      water and diet, this study will provide training on the use of chlorine (sodium hypochlorite)&#xD;
      for water purification and multivitamins for nutritional supplementation. In some villages,&#xD;
      individuals selected for their social connectedness will be trained and given coupons that&#xD;
      can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked&#xD;
      to spread this information and distribute coupons to four people of their choosing. In other&#xD;
      villages, individuals selected at random will receive the same training, materials, and&#xD;
      instructions. A second wave of coupon distribution will provide coupons to those who received&#xD;
      a coupon from the original &quot;seed&quot; groups so that they may disperse these coupons further out&#xD;
      in the social networks. Over the following months, study investigators will look at how&#xD;
      knowledge of these health practices, and uptake or and adherence to the practices, spreads&#xD;
      throughout the villages.&#xD;
&#xD;
      More specifically, the investigators will examine the speed and extent of spreading of these&#xD;
      new health practices after introducing them to three different initial &quot;seed&quot; groups: (1)&#xD;
      people chosen on the basis of being named as a friend by many people in their village, (2)&#xD;
      people chosen based on being named as a friend by a randomly chosen individual, and (3) a&#xD;
      group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or&#xD;
      to a greater extent when the intervention is started in groups 1 and 2 versus group 3&#xD;
      (control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention Spread</measure>
    <time_frame>October 2012</time_frame>
    <description>Use of health product among community members will be tracked.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">5773</enrollment>
  <condition>Malnutrition</condition>
  <condition>Dysentery</condition>
  <condition>Social Transmission of Health Behaviors</condition>
  <arm_group>
    <arm_group_label>Random-Cloro</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>exposure to water chlorination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Random-Vitamin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>exposure to vitamin use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indegree-Cloro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high in-degree, exposure to water chlorination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indegree-Vitamin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high in-degree, exposure to vitamin use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nominated-Cloro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nominated by random, exposure to water chlorination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nominated-Vitamin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nominated by random, exposure to vitamin use</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exposure to vitamin use</intervention_name>
    <description>&quot;Seed&quot; individuals in village are given daily adult multivitamin, with training on use and general nutrition information, along with coupons to distribute to others in village</description>
    <arm_group_label>Indegree-Vitamin</arm_group_label>
    <arm_group_label>Nominated-Vitamin</arm_group_label>
    <arm_group_label>Random-Vitamin</arm_group_label>
    <other_name>Medox Forte</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exposure to water chlorination</intervention_name>
    <description>&quot;Seed&quot; individuals in village are given Clorox bleach for water purification, with training on use and general information on water hygiene, along with coupons to distribute to others in village</description>
    <arm_group_label>Indegree-Cloro</arm_group_label>
    <arm_group_label>Nominated-Cloro</arm_group_label>
    <arm_group_label>Random-Cloro</arm_group_label>
    <other_name>Clorox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>high in-degree</intervention_name>
    <description>&quot;Seed&quot; individuals for starting intervention are chosen on the basis of high (social network) in-degree</description>
    <arm_group_label>Indegree-Cloro</arm_group_label>
    <arm_group_label>Indegree-Vitamin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>nominated by random</intervention_name>
    <description>&quot;Seed&quot; individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual</description>
    <arm_group_label>Nominated-Cloro</arm_group_label>
    <arm_group_label>Nominated-Vitamin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents of Targeted Communities, ages 15 and up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children younger than age 15&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas A Christakis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Keegan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Thomas Keegan, Ph.D.</investigator_full_name>
    <investigator_title>Project Director</investigator_title>
  </responsible_party>
  <keyword>social networks</keyword>
  <keyword>nutrition</keyword>
  <keyword>vitamins</keyword>
  <keyword>chlorine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysentery</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672580
org study id: Lempira_Phase2
nct id: NCT01672580
lead sponsor: 
collaborator: 
has dmc: No
This project will examine the spread of health interventions with a randomized control trial
      design by introducing public health interventions in 32 villages in the Honduran Department
      of Lempira. Based on identified public health needs in the region, namely improved drinking
      water and diet, this study will provide training on the use of chlorine (sodium hypochlorite)
      for water purification and multivitamins for nutritional supplementation. In some villages,
      individuals selected for their social connectedness will be trained and given coupons that
      can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked
      to spread this information and distribute coupons to four people of their choosing. In other
      villages, individuals selected at random will receive the same training, materials, and
      instructions. A second wave of coupon distribution will provide coupons to those who received
      a coupon from the original "seed" groups so that they may disperse these coupons further out
      in the social networks. Over the following months, study investigators will look at how
      knowledge of these health practices, and uptake or and adherence to the practices, spreads
      throughout the villages.

      More specifically, the investigators will examine the speed and extent of spreading of these
      new health practices after introducing them to three different initial "seed" groups: (1)
      people chosen on the basis of being named as a friend by many people in their village, (2)
      people chosen based on being named as a friend by a randomly chosen individual, and (3) a
      group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or
      to a greater extent when the intervention is started in groups 1 and 2 versus group 3
      (control group).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Intervention Spread
time frame: October 2012
description: Use of health product among community members will be tracked.
arm group label: Random-Cloro
arm group type: Active Comparator
description: exposure to water chlorination
arm group label: Random-Vitamin
arm group type: Active Comparator
description: exposure to vitamin use
arm group label: Indegree-Cloro
arm group type: Experimental
description: high in-degree, exposure to water chlorination
arm group label: Indegree-Vitamin
arm group type: Experimental
description: high in-degree, exposure to vitamin use
arm group label: Nominated-Cloro
arm group type: Experimental
description: nominated by random, exposure to water chlorination
arm group label: Nominated-Vitamin
arm group type: Experimental
description: nominated by random, exposure to vitamin use
intervention type: Behavioral
intervention name: exposure to vitamin use
description: "Seed" individuals in village are given daily adult multivitamin, with training on use and general nutrition information, along with coupons to distribute to others in village
arm group label: Indegree-Vitamin
arm group label: Nominated-Vitamin
arm group label: Random-Vitamin
other name: Medox Forte
intervention type: Behavioral
intervention name: exposure to water chlorination
description: "Seed" individuals in village are given Clorox bleach for water purification, with training on use and general information on water hygiene, along with coupons to distribute to others in village
arm group label: Indegree-Cloro
arm group label: Nominated-Cloro
arm group label: Random-Cloro
other name: Clorox
intervention type: Behavioral
intervention name: high in-degree
description: "Seed" individuals for starting intervention are chosen on the basis of high (social network) in-degree
arm group label: Indegree-Cloro
arm group label: Indegree-Vitamin
intervention type: Behavioral
intervention name: nominated by random
description: "Seed" individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual
arm group label: Nominated-Cloro
arm group label: Nominated-Vitamin
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicholas A Christakis, MD, PhD
role: Principal Investigator
affiliation: Yale University
last name: Thomas Keegan, PhD
role: Study Director
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Thomas Keegan, Ph.D.
investigator title: Project Director
mesh term: Dysentery
mesh term: Malnutrition
mesh term: Vitamins