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

This study has been completed.
Sponsor:
Collaborators:
Kenya Medical Research Institute
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01548599
First received: March 5, 2012
Last updated: August 19, 2014
Last verified: August 2014

March 5, 2012
August 19, 2014
April 2012
July 2013   (final data collection date for primary outcome measure)
  • Plasma HIV viral load and CD4 count [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Compare viral load and cluster of differentiation 4 (CD4) count from baseline to one year among intervention and control arms.
  • Food insecurity [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Collect and analyze measures of food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS).
  • Economic outcomes [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Assess food expenditures and non-food expenditures. A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire will be used to measure: a) expenditures (food, health, education and productive investments); b) consumption (food and non-food); c) income (from agriculture and all sources); and d) inter-household commodity and cash transfers.
  • Sexual risk behaviors [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.
  • Food frequency [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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.
  • Women's empowerment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess women's empowerment every six months
  • Plasma HIV viral load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will collect and analyze viral load every six months during the study.
  • Sexual risk behaviors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess sexual risk behaviors every six months.
  • HAART adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess HAART adherence using an unannounced pill count every three months.
Complete list of historical versions of study NCT01548599 on ClinicalTrials.gov Archive Site
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Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

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.

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 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV
  • Malnutrition
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.
  • Experimental: Multi-sectoral agricultural intervention
    Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
    Intervention: Other: Multi-sectoral agricultural intervention
  • No Intervention: Control
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01548599
Shamba Maisha, R34MH094215-01
No
University of California, San Francisco
University of California, San Francisco
  • National Institute of Mental Health (NIMH)
  • Kenya Medical Research Institute
  • University of California, Davis
Principal Investigator: Craig R Cohen, MD, MPH University of California, San Francisco
Principal Investigator: Sheri Weiser, MD University of California, San Francisco
Principal Investigator: Elizabeth Bukusi, MBChB, M.Med Kenya Medical Research Institute
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP