Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya (Shamba)
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|ClinicalTrials.gov Identifier: NCT01548599|
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Malnutrition||Other: Multi-sectoral agricultural intervention||Not Applicable|
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:
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
- Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year [ Time Frame: 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 [ Time Frame: 1 year ]Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.
- Change From Baseline in Frequency of Food Consumption at 1 Year [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- Change From Baseline in Weekly Household Food Expenditures at Year 1 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548599
|Migori District Hospital|
|Migori, Nyanza, Kenya|
|Rongo District Hospital|
|Rongo, Nyanza, Kenya|
|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|