NCT02979418

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 28, 2016

Last Update Submit

November 10, 2020

Conditions

Maternal and Child HealthHIV

Keywords

Water insecurity

Outcome Measures

Primary Outcomes (4)

  • 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)

    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).

    2 years

  • 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)

    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).

    2 years

  • 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)

    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).

    2 years

  • Determine if water insecurity (novel scale) is detrimental to economic security (asset index) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)

    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).

    2 years

Secondary Outcomes (1)

  • Determining if water insecurity (measured using a novel tool) will differ by HIV status

    2 years

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A cohort of postpartum HIV-infected and -uninfected women (ratio 1:1) who were previously enrolled into the Pith Moromo (clinical trials ID: NCT02974972) research study in Nyanza, Kenya.

You may qualify if:

  • Women \>18 years of age with infants enrolled into the Pith Moromo (clinical trials ID: NCT02974972) study
  • Infants born to pregnant women enrolled in the cohort study

You may not qualify if:

  • Individuals \<18 years of age that are not infants born to women enrolled in the cohort study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 27959881RESULT

  • 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: 28749760RESULT

  • 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: 31333167RESULT

  • 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: 32482382RESULT

  • 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: 30231793RESULT

  • Alvarez GG, Miller JD, Santoso MV, Wekesa P, Owuor PM, Onono M, Young SL. Prevalence and Covariates of Food Insecurity Across the First 1000 Days Among Women of Mixed HIV Status in Western Kenya: A Longitudinal Perspective. Food Nutr Bull. 2021 Sep;42(3):319-333. doi: 10.1177/0379572121999024. Epub 2021 May 20.

    PMID: 34011176DERIVED

  • Benzaken CL, Miller JD, Onono M, Young SL. Development of a cumulative metric of vaccination adherence behavior and its application among a cohort of 12-month-olds in western Kenya. Vaccine. 2020 Apr 16;38(18):3429-3435. doi: 10.1016/j.vaccine.2020.03.011. Epub 2020 Mar 14.

    PMID: 32184035DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 1, 2016

Study Start

February 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

November 13, 2020

Record last verified: 2020-11