Clinical trial NCT03170986: Multi-Sectoral Agricultural Intervention to Improve Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya
Official title: Multi-Sectoral Agricultural Intervention to Improve Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition, Child Neurobehavioral Development
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Kenya Medical Research Institute
name: University of California, San Francisco
name: University of South Carolina
name: Massachusetts General Hospital
name: Harvard Medical School (HMS and HSDM)
name: Boston University
First posted: 2017-05-31
Enrollment: 704
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Compound/homesteads are eligible to participate if it has an adult who is a participant in the parent study, Households within the compound/homesteads are eligible if it has (1) a resident related to the adult participant in the parent study, (2) \>1 child(ren) 6- to 36-months old, (3) the child(ren) have a parent/primary guardian age \>18 years old who resides in the compound/homestead, (4) the caregiver intends to stay in the study area for the next 24 months with the child.
* Children: Age 6- to 36-months old, resident in a household in the compound/homestead of participant in the parent study. Adults: Parent or guardian of eligible child, age \>18 years old, is the primary caregiver for the child(ren), and is either a participant in parent study or resident in compound/homestead of participant in the parent study.

Exclusion Criteria:

* Households in which no resident is related to the adult participant in the parent study (e.g., non-relative renters) because unrelated household members would not be expected, in Luo society, to share human, financial, or food resources with the index participant. These situations are rare in Nyanza Region.
* Children who have severe malnutrition (below -3 z-scores of the median WHO growth standards).180 Children with severe malnutrition will be excluded because they will be referred for intensive care, including feeding support.

Primary outcomes:
measure: Weight for Length Z Score
timeFrame: 24 months
Secondary outcomes:
measure: Morbidity
timeFrame: 24 months
measure: Neurobehavioral Development
timeFrame: 24 months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Kitare
city: Homa Bay
country: Kenya
facility: Sindo
city: Kisumu
country: Kenya
facility: Hongo Ogosa
city: Kisumu
country: Kenya
facility: Kisumu District Hospital
city: Kisumu
country: Kenya
facility: Lumumba
city: Kisumu
country: Kenya
facility: Nyang'Ande
city: Kisumu
country: Kenya
facility: Pandipieri
city: Kisumu
country: Kenya
facility: Railways
city: Migori
country: Kenya
facility: Minyenya
city: Migori
country: Kenya
facility: Muhuru Bay
city: Migori
country: Kenya
facility: Ngodhe
city: Migori
country: Kenya
facility: Nyamasare
city: Migori
country: Kenya
facility: Osingo
city: Migori
country: Kenya
facility: Oyani
city: Migori
country: Kenya
facility: Sori Lakeside
city: Migori
country: Kenya
facility: Suna Ragana
Study officials:
References: