HIV Clinical Trial
— PENOfficial title:
Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health
NCT number | NCT02979418 |
Other study ID # | STU00203155 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | July 31, 2017 |
Verified date | November 2020 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 266 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Individuals <18 years of age that are not infants born to women enrolled in the cohort study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Kenya Medical Research Institute |
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. 2020 May 15:113043. doi: 10.1016/j.socscimed.2020.113043. [ — View 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 — View 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 Hea — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Determining if water insecurity (measured using a novel tool) will differ by HIV status | 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 | 2 years |
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