Multi-Sectoral Agricultural Intervention to Improve Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170986
• Other study ID #: H16-101UCSF
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2020
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition, Child Neurobehavioral Development

Intervention

Behavioral:
• Multisectoral agriculture and Microfinance Intervention

Locations

Country	Name	City	State
Kenya	Kitare	Homa Bay
Kenya	Sindo	Homa Bay
Kenya	Hongo Ogosa	Kisumu
Kenya	Kisumu District Hospital	Kisumu
Kenya	Lumumba	Kisumu
Kenya	Nyang'Ande	Kisumu
Kenya	Pandipieri	Kisumu
Kenya	Railways	Kisumu
Kenya	Minyenya	Migori
Kenya	Muhuru Bay	Migori
Kenya	Ngodhe	Migori
Kenya	Nyamasare	Migori
Kenya	Osingo	Migori
Kenya	Oyani	Migori
Kenya	Sori Lakeside	Migori
Kenya	Suna Ragana	Migori

Sponsors (8)

Lead Sponsor	Collaborator
University of Connecticut	Boston Children’s Hospital, Boston University, Harvard Medical School, Kenya Medical Research Institute, Massachusetts General Hospital, University of California, San Francisco, University of South Carolina

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight for Length Z Score	Weight in KG, Length in CM	24 months
Secondary	Morbidity	Number of incident respiratory and diarrheal illnesses in prior 2 weeks	24 months
Secondary	Neurobehavioral Development	Cognitive, Motor, and Social Development Score Using the Profile for Child Monitoring Measure	24 months