Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

NCT02815579 | Completed Results

• 2 other identifiers: P0503135R01MH107330-01
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 16

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.

Conditions

HIV

Keywords

HIV; Food insecurity; Microcredit loan; Agriculture; Livelihoods

Outcome Measures

Primary Outcomes (1)

• Change in Proportion of Viral Load Suppression (<=200 Copies/mL)

  The outcome was the change from baseline to the end of follow-up (2 years) in the proportion of participants in viral load suppression (≤200 copies/mL) compared between study groups using difference-in-differences analyses.

  Baseline and endline (2 years after enrollment)

Secondary Outcomes (10)

• Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3

  Baseline and endline (2 years after enrollment)

• Change (i.e. Linear Trend) in Mean Physical Health Status

  Baseline and endline (2 years after enrollment)

• Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition

  Baseline and endline (2 years after enrollment)

• Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months

  Baseline and endline (2 years after enrollment)

• Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score

  Baseline and endline (2 years after enrollment)

Study Arms (2)

Intervention

EXPERIMENTAL

The Shamba Maisha Intervention includes: a) a loan (\~$175) from a well-established Kenyan bank for purchasing agricultural implements and commodities; b) agricultural implements to be purchased with the 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

Control

NO INTERVENTION

Participants in the control arm will receive the standard of care.

Interventions

Shamba Maisha Intervention OTHER

A) A loan (\~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator
• University of South Carolina: collaborator
• University of Connecticut: collaborator
• University of Pennsylvania: collaborator

Study Sites (16)

Kitare

Suba, Homa Bay County, Kenya

Location

Sindo

Suba, Homa Bay County, Kenya

Location

Muhuru Bay

Nyatike, Migori County, Kenya

Location

Sori Lakeside

Nyatike, Migori County, Kenya

Location

Minyenya

Rongo, Migori County, Kenya

Location

Ngode

Rongo, Migori County, Kenya

Location

Oyani

Rongo, Migori County, Kenya

Location

Nyamasare

Uriri, Migori County, Kenya

Location

Hongo Ogosa

Kisumu, Kenya

Location

Kisumu District Hospital

Kisumu, Kenya

Location

Lumumba

Kisumu, Kenya

Location

Nyangande

Kisumu, Kenya

Location

Pandiperi

Kisumu, Kenya

Location

Railways

Kisumu, Kenya

Location

Osingo

Migori, Kenya

Location

Suna Ragana

Migori, Kenya

Location

Related Publications (30)

• Weiser SD, Young SL, Cohen CR, Kushel MB, Tsai AC, Tien PC, Hatcher AM, Frongillo EA, Bangsberg DR. Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS. Am J Clin Nutr. 2011 Dec;94(6):1729S-1739S. doi: 10.3945/ajcn.111.012070. Epub 2011 Nov 16.

  PMID: 22089434 BACKGROUND

• National AIDS and STI Control Programme, Ministry of Health, Kenya. September 2013. Kenya AIDS Indicator Survey 2012: Preliminary Report. Nairobi, Kenya

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• McMahon JH, Wanke CA, Elliott JH, Skinner S, Tang AM. Repeated assessments of food security predict CD4 change in the setting of antiretroviral therapy. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):60-3. doi: 10.1097/QAI.0b013e318227f8dd.

  PMID: 21694604 BACKGROUND

• Wang EA, McGinnis KA, Fiellin DA, Goulet JL, Bryant K, Gibert CL, Leaf DA, Mattocks K, Sullivan LE, Vogenthaler N, Justice AC; VACS Project Team. Food insecurity is associated with poor virologic response among HIV-infected patients receiving antiretroviral medications. J Gen Intern Med. 2011 Sep;26(9):1012-8. doi: 10.1007/s11606-011-1723-8. Epub 2011 May 15.

  PMID: 21573882 BACKGROUND

• Weiser SD, Palar K, Frongillo EA, Tsai AC, Kumbakumba E, Depee S, Hunt PW, Ragland K, Martin J, Bangsberg DR. Longitudinal assessment of associations between food insecurity, antiretroviral adherence and HIV treatment outcomes in rural Uganda. AIDS. 2014 Jan 2;28(1):115-20. doi: 10.1097/01.aids.0000433238.93986.35.

  PMID: 23939234 BACKGROUND

• Nagata JM, Magerenge RO, Young SL, Oguta JO, Weiser SD, Cohen CR. Social determinants, lived experiences, and consequences of household food insecurity among persons living with HIV/AIDS on the shore of Lake Victoria, Kenya. AIDS Care. 2012;24(6):728-36. doi: 10.1080/09540121.2011.630358. Epub 2011 Dec 7.

  PMID: 22150119 BACKGROUND

• Weiser SD, Tsai AC, Gupta R, Frongillo EA, Kawuma A, Senkungu J, Hunt PW, Emenyonu NI, Mattson JE, Martin JN, Bangsberg DR. Food insecurity is associated with morbidity and patterns of healthcare utilization among HIV-infected individuals in a resource-poor setting. AIDS. 2012 Jan 2;26(1):67-75. doi: 10.1097/QAD.0b013e32834cad37.

  PMID: 21904186 BACKGROUND

• Young S, Wheeler AC, McCoy SI, Weiser SD. A review of the role of food insecurity in adherence to care and treatment among adult and pediatric populations living with HIV and AIDS. AIDS Behav. 2014 Oct;18 Suppl 5(0 5):S505-15. doi: 10.1007/s10461-013-0547-4.

  PMID: 23842717 BACKGROUND

• Weiser SD, Gupta R, Tsai AC, Frongillo EA, Grede N, Kumbakumba E, Kawuma A, Hunt PW, Martin JN, Bangsberg DR. Changes in food insecurity, nutritional status, and physical health status after antiretroviral therapy initiation in rural Uganda. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):179-86. doi: 10.1097/QAI.0b013e318261f064.

  PMID: 22692093 BACKGROUND

• 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.

  BACKGROUND

• Weiser SD, Fernandes KA, Brandson EK, Lima VD, Anema A, Bangsberg DR, Montaner JS, Hogg RS. The association between food insecurity and mortality among HIV-infected individuals on HAART. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):342-9. doi: 10.1097/QAI.0b013e3181b627c2.

  PMID: 19675463 BACKGROUND

• Musumari PM, Feldman MD, Techasrivichien T, Wouters E, Ono-Kihara M, Kihara M. "If I have nothing to eat, I get angry and push the pills bottle away from me": A qualitative study of patient determinants of adherence to antiretroviral therapy in the Democratic Republic of Congo. AIDS Care. 2013;25(10):1271-7. doi: 10.1080/09540121.2013.764391. Epub 2013 Feb 6.

  PMID: 23383757 BACKGROUND

• Musumari PM, Wouters E, Kayembe PK, Kiumbu Nzita M, Mbikayi SM, Suguimoto SP, Techasrivichien T, Lukhele BW, El-Saaidi C, Piot P, Ono-Kihara M, Kihara M. Food insecurity is associated with increased risk of non-adherence to antiretroviral therapy among HIV-infected adults in the Democratic Republic of Congo: a cross-sectional study. PLoS One. 2014 Jan 15;9(1):e85327. doi: 10.1371/journal.pone.0085327. eCollection 2014.

  PMID: 24454841 BACKGROUND

• Sasaki Y, Kakimoto K, Dube C, Sikazwe I, Moyo C, Syakantu G, Komada K, Miyano S, Ishikawa N, Kita K, Kai I. Adherence to antiretroviral therapy (ART) during the early months of treatment in rural Zambia: influence of demographic characteristics and social surroundings of patients. Ann Clin Microbiol Antimicrob. 2012 Dec 28;11:34. doi: 10.1186/1476-0711-11-34.

  PMID: 23270312 BACKGROUND

• Byron E, Gillespie S, Nangami M. Integrating nutrition security with treatment of people living with HIV: lessons from Kenya. Food Nutr Bull. 2008 Jun;29(2):87-97. doi: 10.1177/156482650802900202.

  PMID: 18693472 BACKGROUND

• The World Bank. HIV/AIDS, Nutrition, and Food Security: What we can do. Washington DC2007.

  BACKGROUND

• UNAIDS. Report on the global AIDS epidemic. Geneva: Joint United Nations Programme on HIV/AIDS;2008.

  BACKGROUND

• World Health Organization. HIV, food security, and nutrition: World Food Program, UNAIDS;2008.

  BACKGROUND

• Mamlin J, Kimaiyo S, Lewis S, Tadayo H, Jerop FK, Gichunge C, Petersen T, Yih Y, Braitstein P, Einterz R. Integrating nutrition support for food-insecure patients and their dependents into an HIV care and treatment program in Western Kenya. Am J Public Health. 2009 Feb;99(2):215-21. doi: 10.2105/AJPH.2008.137174. Epub 2008 Dec 4.

  PMID: 19059851 BACKGROUND

• USAID. Feed the Future Program, country profile for Kenya. http://www.feedthefuture.gov/country/kenya. Accessed August 4, 2014.

  BACKGROUND

• KickStart. KickStart Impact. http://www.kickstart.org/what-we-do/impact/. Accessed July 11, 2014.

  BACKGROUND

• 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.

  BACKGROUND

• Nicastro TM, Mocello AR, Weke E, Bukusi EA, Frongillo EA, Cohen CR, Weiser SD, Kadiyala S, Harris-Fry HA. Effect of a climate-smart intervention on agriculture and nutrition of people with HIV. AIDS. 2025 Sep 1;39(11):1650-1655. doi: 10.1097/QAD.0000000000004234. Epub 2025 May 14.

  PMID: 40372058 DERIVED

• Richards AL, Hiepler AJ, Frongillo EA, Khan S, Holding P, Nanga K, Kammerer B, Otieno P, Butler LM. Influence of recurrent assessments during data collection on caregivers and young children for an agricultural livelihood intervention in Kenya: a qualitative study. BMJ Open. 2024 Jun 8;14(6):e077637. doi: 10.1136/bmjopen-2023-077637.

  PMID: 38851226 DERIVED

• Sheira LA, Wekesa P, Cohen CR, Weke E, Frongillo EA, Mocello AR, Dworkin SL, Burger RL, Weiser SD, Bukusi EA. Impact of a livelihood intervention on gender roles and relationship power among people with HIV. AIDS. 2024 Jan 1;38(1):95-104. doi: 10.1097/QAD.0000000000003742. Epub 2023 Sep 29.

  PMID: 37788108 DERIVED

• Cohen CR, Weke E, Frongillo EA, Sheira LA, Burger R, Mocello AR, Wekesa P, Fisher M, Scow K, Thirumurthy H, Dworkin SL, Shade SB, Butler LM, Bukusi EA, Weiser SD. Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2246158. doi: 10.1001/jamanetworkopen.2022.46158.

  PMID: 36508217 DERIVED

• Miller JD, Frongillo EA, Weke E, Burger R, Wekesa P, Sheira LA, Mocello AR, Bukusi EA, Otieno P, Cohen CR, Weiser SD, Young SL. Household Water and Food Insecurity Are Positively Associated with Poor Mental and Physical Health among Adults Living with HIV in Western Kenya. J Nutr. 2021 Jun 1;151(6):1656-1664. doi: 10.1093/jn/nxab030.

  PMID: 33709134 DERIVED

• McDonough A, Weiser SD, Daniel A, Weke E, Wekesa P, Burger R, Sheira L, Bukusi EA, Cohen CR. "When I Eat Well, I Will Be Healthy, and the Child Will Also Be Healthy": Maternal Nutrition among HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya. Curr Dev Nutr. 2020 Mar 13;4(4):nzaa032. doi: 10.1093/cdn/nzaa032. eCollection 2020 Apr.

  PMID: 32270133 DERIVED

Results Point of Contact

• Title: Dr. Sheri Weiser
• Organization: University of California, San Francisco

Sheri.Weiser@ucsf.edu

(628) 206-2427

Study Officials

• Sheri D Weiser, MD, MPH

  Departments of Medicine, UCSF

  PRINCIPAL INVESTIGATOR

• Craig R Cohen, MD, MPH

  Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 25, 2024
• Results First Posted: January 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (16)