Anemia, Iron-deficiency Clinical Trial
Official title:
Diarrhea, Malaria, Anemia, and Helminthiasis Prevention Through Household-based Interventions in Rural Western Kenya: the Nyando Integrated Child Health and Education (NICHE) Project
The purpose of the study is to evaluate the effectiveness of household-based distribution of evidence-based health products and to measure the health impact of these combined interventions on a population basis.
Nyanza Province has the highest mortality rates for infants and children under 5 years of
age and the highest HIV prevalence rates in Kenya. Burden of disease in western Kenya is
further characterized by endemic malaria transmission, diarrheal diseases due to poor access
to safe water, and iron deficiency anemia (IDA) in over 60% of children. Access to health
interventions in rural Nyanza Province is poor due to limited transportation and
communication infrastructure. Delivery of household-based interventions through local
institutions offers the potential for increased utilization and improved health outcomes in
rural areas. The Centers for Disease Control and Prevention (CDC) in partnership with the
Rotary-supported Safe Water and AIDS Project (SWAP), initiated a program in 2007 that
combines household, clinic, school, and local commercial distribution approaches to increase
access to various evidence-based health products (WaterGuard(TM) and PuR(TM) water
disinfectant products, water storage containers, soap, insecticide treated bednets,
micronutrient Sprinkles(TM), and albendazole) and measures the health impact of these
combined interventions on a population basis.
Evaluation of the intervention will take place over 36 months and will include: 1) baseline
and follow-up cross sectional surveys among households in communities visited by SWAP for
purchase of products; 2) active household surveillance of diarrhea, febrile illness and
Sprinkles(TM) usage; 3) testing of hemoglobin and iron status and anthropometry measurement
among children aged 6-35 months; 4) focus groups and targeted interviews to assess the
acceptability of health products; and 5) other program evaluation methods.
During the baseline and follow-up surveys, demographic information, water, sanitation,
hygiene, and health information, dietary intake history, and other data will be collected by
questionnaire. A blood specimen collected by fingerstick will be used to test for hemoglobin
concentration, malaria parasitemia, and iron status. Follow-up surveys 12 and 24 months
after baseline data collection will include collection of similar data to assess the
effectiveness of product distribution. Anthropometry will be measured at baseline, 12, and
24 months. Qualitative information on user preferences will be obtained using ongoing focus
groups, observations and targeted interviews. The results of these evaluations will be
published in reports distributed to SWAP, the Kenyan government, and local NGO's and in
peer-reviewed journals.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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