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Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya (Shamba R01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02815579
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of South Carolina
University of Connecticut
University of Pennsylvania
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.

Condition or disease Intervention/treatment Phase
HIV Other: Shamba Maisha Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
The Shamba Maisha Intervention includes: a) a microcredit loan (~$140) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the microcredit loan including the KickStart treadle pump, seeds, fertilizers and pesticides; and c) education in financial management and sustainable farming practices occurring in the setting of patient support groups.
Other: Shamba Maisha Intervention
A) A microcredit loan (~$140) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices

No Intervention: Control
Participants in the control arm will receive the standard of care.



Primary Outcome Measures :
  1. Viral load suppression [ Time Frame: Every 6 months for a total of 2 years ]
    Non-detectable HIV viral load (lower limit of detection of <20 copies/mL)


Secondary Outcome Measures :
  1. Absolute CD4 count [ Time Frame: Every 6 months for a total of 2 years ]
    Change in CD4 count

  2. Physical Health Status [ Time Frame: Every 6 months for a total of 2 years ]
    MOS-HIV, a tool for assessing health-related quality of life that has been validated in resource-limited settings

  3. WHO stage III/IV disease [ Time Frame: Assessed at every clinic visit during 2 years of follow-up ]
    WHO stage III/IV disease

  4. Hospitalizations [ Time Frame: During 2 years of follow-up ]
    Assessed every 6 months for a total of 2 years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected adults
  • Currently receiving ART
  • Belong to a patient support group or demonstrate willingness to join a support group
  • Agree to save the down payment (~$10) required for the microcredit loan
  • Have evidence of moderate to severe food insecurity based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI<18.5) based on FACES medical records during the year preceding recruitment
  • Have access to farming land and available surface water in the form of lakes, rivers, ponds and shallow wells

Exclusion Criteria:

  • People who do not speak Dholuo, Swahili, or English
  • Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the research assistant

Information from the National Library of Medicine

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): NCT02815579


Locations
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Kenya
Kitare
Suba, Homa Bay, Kenya
Sindo
Suba, Homa Bay, Kenya
Muhuru Bay
Nyatike, Migori, Kenya
Sori Lakeside
Nyatike, Migori, Kenya
Minyenya
Rongo, Migori, Kenya
Ngode
Rongo, Migori, Kenya
Oyani
Rongo, Migori, Kenya
Nyamasare
Uriri, Migori, Kenya
Hongo Ogosa
Kisumu, Kenya
Kisumu District Hospital
Kisumu, Kenya
Lumumba
Kisumu, Kenya
Nyangande
Kisumu, Kenya
Pandiperi
Kisumu, Kenya
Railways
Kisumu, Kenya
Osingo
Migori, Kenya
Suna Ragana
Migori, Kenya
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of South Carolina
University of Connecticut
University of Pennsylvania
Investigators
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Principal Investigator: Sheri D Weiser, MD, MPH Departments of Medicine, UCSF
Principal Investigator: Craig R Cohen, MD, MPH Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] March 15, 2017

Publications of Results:
Weiser S, Fernandes K, Anema A, et al. Food insecurity as a barrier to antiretroviral therapy (ART) adherence among HIV-infected individuals in British Columbia. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Cape Town, South Africa2009.

Other Publications:
National AIDS and STI Control Programme, Ministry of Health, Kenya. September 2013. Kenya AIDS Indicator Survey 2012: Preliminary Report. Nairobi, Kenya
Place F, Adato M, Hebinck P. Understanding rural poverty and investment in agriculture: an assessment of integrated quantitative and qualitative research in western Kenya. World Dev. 2007;35(2):312-325.
Stoorvogel J, Smaling E. Assessment of soil nutrient depletion in sub-Saharan Africa: 1983-2000. Report No. 28, Vols. I-IV. Wageningin, Netherlands: Winand Staring Center; 1990.
The World Bank. HIV/AIDS, Nutrition, and Food Security: What we can do. Washington DC2007.
UNAIDS. Report on the global AIDS epidemic. Geneva: Joint United Nations Programme on HIV/AIDS;2008.
World Health Organization. HIV, food security, and nutrition: World Food Program, UNAIDS;2008.
USAID. Feed the Future Program, country profile for Kenya. http://www.feedthefuture.gov/country/kenya. Accessed August 4, 2014.
KickStart. KickStart Impact. http://www.kickstart.org/what-we-do/impact/. Accessed July 11, 2014.
Weiser S, Palar K, Hatcher A, S. Y, Frongillo EA, Laraia BA. Food insecurity and health: A Conceptual Framework. In: Ivers L, ed. Food Insecurity and Public Health. Boston, MA: CRC Press; 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02815579    
Other Study ID Numbers: P0503135
R01MH107330-01 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
HIV
Food insecurity
Microcredit loan
Agriculture
Livelihoods