<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/NCT02979418</url>
  </required_header>
  <id_info>
    <org_study_id>STU00203155</org_study_id>
    <nct_id>NCT02979418</nct_id>
  </id_info>
  <brief_title>Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health</brief_title>
  <acronym>PEN</acronym>
  <official_title>Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will implement the validated household-level water insecurity scale developed by&#xD;
      study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a&#xD;
      range of outcomes linked to water insecurity, such as viral load, hydration status, maternal&#xD;
      depression, stress, food insecurity, and cognitive development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will develop the first well-known household water insecurity scale. Currently,&#xD;
      water insecurity cannot be measured at the level of the household or individual, i.e. at the&#xD;
      endpoint of water use. Although there are myriad national, regional, community, and&#xD;
      hydrological indexes of water availability, to the investigators' knowledge, there is no way&#xD;
      of measuring water access at the household or individual levels. Without a comprehensive,&#xD;
      validated scale to measure household water insecurity, the scientific, programmatic, and&#xD;
      public health communities cannot empirically test the prevalence of household water&#xD;
      insecurity access and its potential impacts on economic, nutrition, disease, and psychosocial&#xD;
      health pathways and outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine if water insecurity (novel scale) is detrimental to physical health (hemoglobin, hair cortisol, other biomarkers) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if water insecurity (novel scale) is detrimental to nutrition (Household Dietary Diversity Scale) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if water insecurity (novel scale) is detrimental to psychosocial health (Perceived Stress Scale, Center for Epidemiology Depression (CES-D) scale, etc.), in ways distinct from food insecurity (Individual Food Insecurity Access Scale)</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if water insecurity (novel scale) is detrimental to economic security (asset index) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determining if water insecurity (measured using a novel tool) will differ by HIV status</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators collected longitudinal data to assess water insecurity among the cohort (using a novel tool) and will compare the prevalences and impacts of water insecurity by HIV status</description>
  </secondary_outcome>
  <enrollment type="Actual">266</enrollment>
  <condition>Maternal and Child Health</condition>
  <condition>HIV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of postpartum HIV-infected and -uninfected women (ratio 1:1) who were previously&#xD;
        enrolled into the Pith Moromo (clinical trials ID: NCT02974972) research study in Nyanza,&#xD;
        Kenya.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women &gt;18 years of age with infants enrolled into the Pith Moromo (clinical trials ID:&#xD;
             NCT02974972) study&#xD;
&#xD;
          -  Infants born to pregnant women enrolled in the cohort study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals &lt;18 years of age that are not infants born to women enrolled in the cohort&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Krumdieck NR, Collins SM, Wekesa P, Mbullo P, Boateng GO, Onono M, Young SL. Household water insecurity is associated with a range of negative consequences among pregnant Kenyan women of mixed HIV status. J Water Health. 2016 Dec;14(6):1028-1031. doi: 10.2166/wh.2016.079.</citation>
    <PMID>27959881</PMID>
  </results_reference>
  <results_reference>
    <citation>Brooks YM, Collins SM, Mbullo P, Boateng GO, Young SL, Richardson RE. Evaluating Human Sensory Perceptions and the Compartment Bag Test Assays as Proxies for the Presence and Concentration of Escherichia coli in Drinking Water in Western Kenya. Am J Trop Med Hyg. 2017 Oct;97(4):1005-1008. doi: 10.4269/ajtmh.16-0878. Epub 2017 Jul 27.</citation>
    <PMID>28749760</PMID>
  </results_reference>
  <results_reference>
    <citation>Miller JD, Fitzgerald KG, Smith AL, Young SL. Geophagy among a Cohort of Kenyan Women with Mixed HIV Status: A Longitudinal Analysis. Am J Trop Med Hyg. 2019 Sep;101(3):654-660. doi: 10.4269/ajtmh.19-0149.</citation>
    <PMID>31333167</PMID>
  </results_reference>
  <results_reference>
    <citation>Boateng GO, Workman CL, Miller JD, Onono M, Neilands TB, Young SL. The syndemic effects of food insecurity, water insecurity, and HIV on depressive symptomatology among Kenyan women. Soc Sci Med. 2022 Feb;295:113043. doi: 10.1016/j.socscimed.2020.113043. Epub 2020 May 15.</citation>
    <PMID>32482382</PMID>
  </results_reference>
  <results_reference>
    <citation>Collins SM, Mbullo Owuor P, Miller JD, Boateng GO, Wekesa P, Onono M, Young SL. 'I know how stressful it is to lack water!' Exploring the lived experiences of household water insecurity among pregnant and postpartum women in western Kenya. Glob Public Health. 2019 May;14(5):649-662. doi: 10.1080/17441692.2018.1521861. Epub 2018 Sep 20.</citation>
    <PMID>30231793</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Sera Young</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Water insecurity</keyword>
  <!-- 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/NCT02979418
org study id: STU00203155
nct id: NCT02979418
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will implement the validated household-level water insecurity scale developed by
      study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a
      range of outcomes linked to water insecurity, such as viral load, hydration status, maternal
      depression, stress, food insecurity, and cognitive development.
This study will develop the first well-known household water insecurity scale. Currently,
      water insecurity cannot be measured at the level of the household or individual, i.e. at the
      endpoint of water use. Although there are myriad national, regional, community, and
      hydrological indexes of water availability, to the investigators' knowledge, there is no way
      of measuring water access at the household or individual levels. Without a comprehensive,
      validated scale to measure household water insecurity, the scientific, programmatic, and
      public health communities cannot empirically test the prevalence of household water
      insecurity access and its potential impacts on economic, nutrition, disease, and psychosocial
      health pathways and outcomes.
observational model: Cohort
time perspective: Prospective
measure: Determine if water insecurity (novel scale) is detrimental to physical health (hemoglobin, hair cortisol, other biomarkers) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)
time frame: 2 years
description: The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).
measure: Determine if water insecurity (novel scale) is detrimental to nutrition (Household Dietary Diversity Scale) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)
time frame: 2 years
description: The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).
measure: Determine if water insecurity (novel scale) is detrimental to psychosocial health (Perceived Stress Scale, Center for Epidemiology Depression (CES-D) scale, etc.), in ways distinct from food insecurity (Individual Food Insecurity Access Scale)
time frame: 2 years
description: The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).
measure: Determine if water insecurity (novel scale) is detrimental to economic security (asset index) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)
time frame: 2 years
description: The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).
measure: Determining if water insecurity (measured using a novel tool) will differ by HIV status
time frame: 2 years
description: The investigators collected longitudinal data to assess water insecurity among the cohort (using a novel tool) and will compare the prevalences and impacts of water insecurity by HIV status
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Krumdieck NR, Collins SM, Wekesa P, Mbullo P, Boateng GO, Onono M, Young SL. Household water insecurity is associated with a range of negative consequences among pregnant Kenyan women of mixed HIV status. J Water Health. 2016 Dec;14(6):1028-1031. doi: 10.2166/wh.2016.079.
PMID: 27959881
citation: Brooks YM, Collins SM, Mbullo P, Boateng GO, Young SL, Richardson RE. Evaluating Human Sensory Perceptions and the Compartment Bag Test Assays as Proxies for the Presence and Concentration of Escherichia coli in Drinking Water in Western Kenya. Am J Trop Med Hyg. 2017 Oct;97(4):1005-1008. doi: 10.4269/ajtmh.16-0878. Epub 2017 Jul 27.
PMID: 28749760
citation: Miller JD, Fitzgerald KG, Smith AL, Young SL. Geophagy among a Cohort of Kenyan Women with Mixed HIV Status: A Longitudinal Analysis. Am J Trop Med Hyg. 2019 Sep;101(3):654-660. doi: 10.4269/ajtmh.19-0149.
PMID: 31333167
citation: Boateng GO, Workman CL, Miller JD, Onono M, Neilands TB, Young SL. The syndemic effects of food insecurity, water insecurity, and HIV on depressive symptomatology among Kenyan women. Soc Sci Med. 2022 Feb;295:113043. doi: 10.1016/j.socscimed.2020.113043. Epub 2020 May 15.
PMID: 32482382
citation: Collins SM, Mbullo Owuor P, Miller JD, Boateng GO, Wekesa P, Onono M, Young SL. 'I know how stressful it is to lack water!' Exploring the lived experiences of household water insecurity among pregnant and postpartum women in western Kenya. Glob Public Health. 2019 May;14(5):649-662. doi: 10.1080/17441692.2018.1521861. Epub 2018 Sep 20.
PMID: 30231793
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Sera Young
investigator title: Associate Professor