Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

Not Applicable

Completed

• Conditions: HIV; Malnutrition
• Interventions: Other: Multi-sectoral agricultural intervention

• Registration Number: NCT01548599
• Lead Sponsor: University of California, San Francisco

Brief Summary

This pilot study aims to determine whether an agricultural intervention will improve food security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk among people living with HIV/AIDS. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.

Detailed Description

Food insecurity and HIV/AIDS are two leading causes of morbidity and mortality in sub-Saharan Africa and are inextricably linked. Since food insecurity contributes to increased HIV transmission risk and higher HIV-related morbidity and mortality, the World Health Organization (WHO), United Nations Programme on HIV/AIDS (UNAIDS), and the World Food Programme have recommended integrating sustainable food production strategies into HIV/AIDS programming. Yet, to date there have been few studies to systematically evaluate the impact of promising food security interventions on health, economic and behavioral outcomes among people living with HIV and AIDS. To address this gap, the investigators plan to test the hypothesis that a multi-sectoral agricultural intervention delivered in Nyanza Province, Kenya will prevent highly active antiretroviral (HAART) treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices. To develop our intervention, th investigators have formed an interdisciplinary collaboration with organizations in the healthcare, agriculture, and microfinance sectors. Our study aims include:

1. The investigators will operationalize and pilot test key design elements of a future cluster randomized clinical trials (RCT) aimed to improve health outcomes among HAART-treated patients in Western Kenya. In conjunction with our collaborating partners, the investigators will develop the different components of the intervention, including: a) randomization procedures for cluster RCT using detailed site assessments; b) agricultural training protocols; c) procedures for control group; d) manual of operations.

2. The investigators will conduct a pilot study of an agricultural intervention to determine the preliminary impact of the intervention on mediating outcomes (food security, and household economic indicators), and on primary health outcomes of interest for the planned RCT (HIV treatment outcomes, HIV transmission risk and women's empowerment). Up to one hundred and sixty HIV-infected farmers on HAART in Western Kenya (80 at an intervention clinic and 80 at a control clinic) will be enrolled and followed for 1 year. Impacts of our intervention on mediating and primary health outcomes will be investigated separately and jointly to provide a preliminary assessment of possible direct and indirect intervention effects.

3. The investigators will assess the acceptability and feasibility of intervention and control conditions, and systematically translate lessons learned in the pilot study into the design of a cluster RCT. To accomplish Aim 3, the investigators will conduct a mixed methods process evaluation of the different intervention components and their implementation using quantitative, qualitative, and observational methods. The investigators will prepare an R01 grant for submission based on lessons learned. The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa.

The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa.

Study Timeline

• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Study Start: 2012-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2019-11-07
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Results First Posted: 2020-04-14
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• HIV-infected
• 18-49 years old
• Currently receiving HAART
• Belong to a patient support group or demonstrate willingness to join a support group.
• Have access to farming land and available surface water
• Have evidence of food insecurity, hunger and/or malnutrition (BMI<18.5 kg) based on FACES medical records during the year preceding recruitment.
• Participants must also agree to save the down payment (~$7) required for the loan, participate in the Adok Timo training.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-sectoral agricultural intervention	Multi-sectoral agricultural intervention	Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.

Primary Outcome Measures

Name	Time	Method
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year	1 year	Compare the percentage of participants who achieve HIV viral suppression (defined as \<40 copies/mL) at 1 year among intervention and control arms.
Change From Baseline in CD4 Count at 1 Year	1 year	Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Weekly Household Food Expenditures at Year 1	1 year	Assess weekly household food expenditures in Kenyan shillings. A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire will be used to measure expenditures for food consumption.
Change From Baseline in Frequency of Food Consumption at 1 Year	Baseline and 1 year	Food frequency will be measured as the number of different foods or food groups and the frequency consumed over a given reference period, as adapted from the World Food Programme Food Consumption Score. Minimum = 0, maximum = 392. Higher scores reflect more frequent food consumption.
Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year	1 year	Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.
Change From Baseline in Food Insecurity at Year 1	Baseline and 1 year	Collect and analyze measures of food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS). Minimum=9, maximum=36. A higher score means worse outcomes (i.e. greater food insecurity).

Trial Locations

Locations (2)

Migori District Hospital; 🇰🇪 Migori, Nyanza, Kenya

Rongo District Hospital; 🇰🇪 Rongo, Nyanza, Kenya