Child Nutrition, Child Neurobehavioral Development Clinical Trial
Official title:
Multi-Sectoral Agricultural Intervention to Improve Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya
This study aims to test the hypothesis that a multi-sectoral agricultural and microfinance intervention designed to improve household food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS will lead to improvements in the nutrition, health and development of children under 5 years old who reside in households of adults who participate in the Shamba Maisha intervention.
HIV and AIDS has had a devastating effect on household food security and wealth in
sub-Saharan Africa through the debilitation of the most productive household members,
decreased household income, and increased caregiver burden. Children under five living in
households affected by HIV and AIDS are at particularly high risk for food insecurity and its
subsequent negative impacts on nutrition, health, and neurobehavioral development outcomes.
While there is widespread agreement that interventions to reduce food insecurity and poverty
may improve ongoing responses to the HIV epidemic, there is a dearth of evidence regarding
the effectiveness of such interventions on the nutritional, health and neurobehavioral
development outcomes of HIV-affected children. Such interventions are most needed in settings
such as Nyanza Region in Western Kenya: a largely rural, agricultural area characterized by
high levels of poverty, HIV, food insecurity, and child mortality.
The investigators have successfully completed a one-year pilot intervention study at two
health facilities in Nyanza Region including 140 (n=72 intervention, n=68 control)
HIV-infected adults on antiretroviral therapy which evaluated the potential effectiveness of
an integrated, multisectoral agricultural and microfinance intervention called "Shamba
Maisha" ("Farm Life"), designed to increase household food security and wealth in
HIV-affected households. Shamba Maisha includes a) a microfinance loan (~$175) for purchasing
agricultural implements and commodities; b) agricultural implements, purchased with the loan,
including a human-powered water pump, seeds, fertilizers and pesticides; and c) education in
financial management and sustainable farming practices occurring in the setting of patient
support groups. The trial demonstrated the feasibility, acceptability, and short-term
effectiveness of Shamba Maisha on improving household food security, diet quality and health
outcomes of adults living with HIV. The investigators have also successfully completed a
one-year companion pediatric study in which they tested preliminary impacts of Shamba Maisha
on nutritional outcomes of HIV-affected children under 5 years old who resided in households
of participants in the parent study (N=200 children and 126 primary caregivers). At baseline,
the investigators observed a significant degree of undernutrition in both groups. They
observed statistically significant gains in weight over time for children over six months old
in the intervention group (group by time interaction, p=0.01) compared to the control group,
but the sample size and follow-up time were insufficient to test effects on height. A larger
sample size in a randomized design with longer follow-up period is needed for a definitive
test of the effectiveness of this intervention on children's health outcomes.
The investigators now propose to leverage the infrastructure of the recently funded cluster
randomized controlled trial, designed to determine the effectiveness of Shamba Maisha on HIV
clinical and other health outcomes of HIV-infected adults in Western Kenya (the 'parent
study'). They propose to assess the impact of the intervention on nutrition, health, and
neurobehavioral development outcomes for HIV-affected children. The parent study will include
8 matched pairs of health facilities, randomized in a 1:1 ratio to the intervention and
control arms, enrolling 44 HIV-infected adult participants per facility (N=704 adults, 50%
female) and followed for 2 years. The proposed study will enroll and follow HIV-affected
children (enrolled at age 6 to <36 months) and their primary caregiver (age >18 years) who
reside in compound/homesteads of participants in the parent study (1:1 ratio, intervention
and control). The study will include a minimum of 352 children (n=176 per study arm) with
their primary caregiver. Specific aims are: Aim 1. To determine the effect of Shamba Maisha
on nutritional, health, and neurobehavioral development outcomes of HIV-affected children
under 5 years old. The investigators hypothesize that children living in intervention
households will have greater somatic growth (weight-for-age, height-for-age, and
weight-for-height z-scores)(primary outcome), reduced morbidity and hospitalizations, and
improved neurobehavioral development outcomes (secondary outcomes) compared to children
living in households that do not receive the intervention. The investigators will collect
data on children's nutrition, health, and neurobehavioral development outcomes over a 2-year
follow-up period. Aim 2. To understand the pathways through which Shamba Maisha may improve
nutritional, health, and neurobehavioral development outcomes of HIV-affected children. The
investigators hypothesize that improvements in household food security and household wealth
will contribute to improved child outcomes through improvements in: child diet, caregiver
physical and mental health, caregiver empowerment, and home environment pathways, and this
study will provide important details about those pathways. Aim 3. To evaluate the incremental
cost and cost-effectiveness of the intervention with respect to children's health outcomes
(in coordination with the parent study's analysis for adults). The investigators will
translate observed reduced morbidity to averted Disability Adjusted Life Years (DALYs), using
disability weights from the Global Burden of Disease, estimate net costs considering the
intervention and averted health care costs, and calculate incremental cost-effectiveness, as
the net cost per DALY averted.
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