Multi-Sectoral Agricultural Intervention to Improve Nutrition, Health, and Developmental Outcomes of HIV-infected and Affected Children in Western Kenya
1 other identifier
interventional
704
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMay 27, 2020
May 1, 2020
3.8 years
May 1, 2017
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Weight for Length Z Score
Weight in KG, Length in CM
24 months
Secondary Outcomes (2)
Morbidity
24 months
Neurobehavioral Development
24 months
Study Arms (2)
Multisectoral Agriculture and Microfinance Arm
EXPERIMENTALControl Arm
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Connecticutlead
- Boston Children's Hospitalcollaborator
- Kenya Medical Research Institutecollaborator
- University of California, San Franciscocollaborator
- University of South Carolinacollaborator
- Massachusetts General Hospitalcollaborator
- Harvard Medical School (HMS and HSDM)collaborator
- Boston Universitycollaborator
Study Sites (16)
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, Kenya
Related Publications (1)
Richards AL, Hiepler AJ, Frongillo EA, Khan S, Holding P, Nanga K, Kammerer B, Otieno P, Butler LM. Influence of recurrent assessments during data collection on caregivers and young children for an agricultural livelihood intervention in Kenya: a qualitative study. BMJ Open. 2024 Jun 8;14(6):e077637. doi: 10.1136/bmjopen-2023-077637.
PMID: 38851226DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Professor
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 31, 2017
Study Start
June 1, 2016
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
Following publication of the main paper(s) for this study, we will make survey data publicly available in the form of an electronic database for researchers who successfully complete a registration process. Survey data will be de-identified and will not contain any direct identifiers or indirect identifiers that could identify participants by inference. Users must submit brief proposals regarding intended use of the data; the study team will determine the scientific soundness of the proposal as part of the decision for the researcher to be able to access the public use dataset.