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

HIV Clinical Trial

— Shamba  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548599
• Other study ID #: Shamba Maisha
• Secondary ID: R34MH094215-01
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Malnutrition

Intervention

Other:
• Multi-sectoral agricultural intervention
Participants in the intervention arm will receive a micro-finance loan and training on financial management and marketing skills. With the loan, each participant will receive vouchers to purchase the following items: the Money Maker hip pump, 50 feet of hosing, fertilizer, and government certified seeds. Participants in the intervention group will also receive training on the use of the Money Maker hip pump, a portable, low-cost, human-powered water pump developed by KickStart. Participants in the intervention group will also receive training from Kickstart on the use of the pump as well as complementary training in best horticultural practices.

Locations

Country	Name	City	State
Kenya	Migori District Hospital	Migori	Nyanza
Kenya	Rongo District Hospital	Rongo	Nyanza

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute, National Institute of Mental Health (NIMH), University of California, Davis

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With HIV Viral Load < 40 Copies/ML at 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.	1 year
Primary	Change From Baseline in CD4 Count at 1 Year	Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.	1 year
Secondary	Change From Baseline in Frequency of Food Consumption at 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.	Baseline and 1 year
Secondary	Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year	Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.	1 year
Secondary	Change From Baseline in Food Insecurity at Year 1	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).	Baseline and 1 year
Secondary	Change From Baseline in Weekly Household Food Expenditures at Year 1	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.	1 year

External Links

•   Research Article on Shamba Maisha: A pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients