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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Malnutrition; HIV

Treatments: Other: Multi-sectoral agricultural intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01548599

Shamba Maisha

R34MH094215-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• None

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Multi-sectoral agricultural intervention

Experimental group

Description:

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

Treatment:

Other: Multi-sectoral agricultural intervention

Control

No Intervention group

Description:

Participants enrolled at one study location will receive the standard of care. At the end of the study, participants in this arm will be eligible for the finance training and those who pay the loan down payment will be eligible for a small loan to purchase a human powered water pump, hosing, fertilizer, and certified seeds.