Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya (Shamba)
Primary Purpose
HIV, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Multi-sectoral agricultural intervention
Sponsored by
About this trial
This is an interventional supportive care trial for HIV focused on measuring HIV, Malnutrition, Food Security, Kenya
Eligibility 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
Sites / Locations
- Migori District Hospital
- Rongo District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multi-sectoral agricultural intervention
Control
Arm Description
Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
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.
Full Information
NCT ID
NCT01548599
First Posted
March 5, 2012
Last Updated
April 6, 2020
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01548599
Brief Title
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Acronym
Shamba
Official Title
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Malnutrition
Keywords
HIV, Malnutrition, Food Security, Kenya
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-sectoral agricultural intervention
Arm Type
Experimental
Arm Description
Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Multi-sectoral agricultural intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year
Description
Compare the percentage of participants who achieve HIV viral suppression (defined as <40 copies/mL) at 1 year among intervention and control arms.
Time Frame
1 year
Title
Change From Baseline in CD4 Count at 1 Year
Description
Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change From Baseline in Frequency of Food Consumption at 1 Year
Description
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.
Time Frame
Baseline and 1 year
Title
Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year
Description
Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.
Time Frame
1 year
Title
Change From Baseline in Food Insecurity at Year 1
Description
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).
Time Frame
Baseline and 1 year
Title
Change From Baseline in Weekly Household Food Expenditures at Year 1
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig R Cohen, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheri Weiser, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Bukusi, MBChB, M.Med
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Migori District Hospital
City
Migori
State/Province
Nyanza
Country
Kenya
Facility Name
Rongo District Hospital
City
Rongo
State/Province
Nyanza
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
31998859
Citation
Butler LM, Bhandari S, Otieno P, Weiser SD, Cohen CR, Frongillo EA. Agricultural and Finance Intervention Increased Dietary Intake and Weight of Children Living in HIV-Affected Households in Western Kenya. Curr Dev Nutr. 2020 Jan 11;4(2):nzaa003. doi: 10.1093/cdn/nzaa003. eCollection 2020 Feb.
Results Reference
derived
PubMed Identifier
31242065
Citation
Hatcher AM, Lemus Hufstedler E, Doria K, Dworkin SL, Weke E, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Mechanisms and perceived mental health changes after a livelihood intervention for HIV-positive Kenyans: Longitudinal, qualitative findings. Transcult Psychiatry. 2020 Feb;57(1):124-139. doi: 10.1177/1363461519858446. Epub 2019 Jun 26. Erratum In: Transcult Psychiatry. 2020 Feb;57(1):231.
Results Reference
derived
PubMed Identifier
27637497
Citation
Weiser SD, Hatcher AM, Hufstedler LL, Weke E, Dworkin SL, Bukusi EA, Burger RL, Kodish S, Grede N, Butler LM, Cohen CR. Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention. AIDS Behav. 2017 Feb;21(2):415-427. doi: 10.1007/s10461-016-1551-2.
Results Reference
derived
PubMed Identifier
25992307
Citation
Cohen CR, Steinfeld RL, Weke E, Bukusi EA, Hatcher AM, Shiboski S, Rheingans R, Scow KM, Butler LM, Otieno P, Dworkin SL, Weiser SD. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial. Springerplus. 2015 Mar 12;4:122. doi: 10.1186/s40064-015-0886-x. eCollection 2015.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2877674/
Description
Research Article on Shamba Maisha: A pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients
Learn more about this trial
Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
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