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: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
HIV
Malnutrition
Other: Multi-sectoral agricultural intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.

  • HAART adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess HAART adherence using an unannounced pill count every three months.

  • Sexual risk behaviors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess sexual risk behaviors every six months.

  • Women's empowerment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will assess women's empowerment every six months


Enrollment: 140
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-sectoral agricultural intervention
Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the 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.
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.

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 WHO, 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548599

Locations
Kenya
Migori District Hospital
Migori Town, Nyanza, Kenya
Rongo District Hospital
Rongo Town, Nyanza, Kenya
Sponsors and Collaborators
University of California, San Francisco
Kenya Medical Research Institute
University of California, Davis
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01548599     History of Changes
Other Study ID Numbers: Shamba Maisha, R34MH094215-01
Study First Received: March 5, 2012
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by University of California, San Francisco:
HIV
Malnutrition
Food Security
Kenya

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 23, 2014