Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya

NCT01548599 | Completed Results

• 2 other identifiers: Shamba MaishaR34MH094215-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Malnutrition

Keywords

HIV; Malnutrition; Food Security; Kenya

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (4)

• Change From Baseline in Frequency of Food Consumption at 1 Year

  Baseline and 1 year

• Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year

  1 year

• Change From Baseline in Food Insecurity at Year 1

  Baseline and 1 year

• Change From Baseline in Weekly Household Food Expenditures at Year 1

  1 year

Study Arms (2)

Multi-sectoral agricultural intervention

EXPERIMENTAL

Participants enrolled at one study location will receive the Multi-sectoral agricultural intervention as specified below under the intervention.

Other: Multi-sectoral agricultural intervention

Control

NO 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.

Interventions

Multi-sectoral agricultural intervention OTHER

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.

Multi-sectoral agricultural intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-infected
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (2)

Migori District Hospital

Migori, Nyanza, Kenya

Location

Rongo District Hospital

Rongo, Nyanza, Kenya

Location

Related Publications (5)

• Nicastro TM, Pincus L, Weke E, Hatcher AM, Burger RL, Lemus-Hufstedler E, Bukusi EA, Cohen CR, Weiser SD. Perceived impacts of a pilot agricultural livelihood and microfinance intervention on agricultural practices, food security and nutrition for Kenyans living with HIV. PLoS One. 2022 Dec 14;17(12):e0278227. doi: 10.1371/journal.pone.0278227. eCollection 2022.

  PMID: 36516159 DERIVED

• 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.

  PMID: 31998859 DERIVED

• 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.

  PMID: 31242065 DERIVED

• 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.

  PMID: 27637497 DERIVED

• 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.

  PMID: 25992307 DERIVED

Related Links

• Research Article on Shamba Maisha: A pilot study assessing impacts of a micro-irrigation intervention on the health and economic wellbeing of HIV patients

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Limitations and Caveats

We could not definitively separate intervention effects from cluster-level variables with 2 communities randomized. The 12-month follow-up could not detect the full range \& sustainability of effects.

Results Point of Contact

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

Sheri.Weiser@ucsf.edu

(415) 314-0665

Study Officials

• 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

  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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Locations

KE (2)