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

December 20, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite major advances in care and treatment for those living with HIV, morbidity and mortality among people living with HIV/AIDS (PLHIV) remains unacceptably high in sub-Saharan Africa (SSA), largely due to the parallel challenges of poverty and food insecurity.[1] In the Nyanza Region of Kenya, 15.1% of the adult population is infected by HIV,[2] and over 50% of the rural population is food insecure, primarily due to unpredictable rainfall and limited irrigation.[3,4] The investigators have previously shown that food insecurity delays antiretroviral therapy (ART) initiation, reduces ART adherence, contributes to worse immunologic and virologic outcomes, and increases morbidity and mortality among PLHIV.[5-16] There has been increasing international recognition that improved food security and reduced poverty are essential components for a successful global response to the HIV epidemic.[17-21] Yet, to date few studies have systematically evaluated the impacts of sustainable food security interventions on health, economic, and behavioral outcomes among PLHIV. Agricultural interventions, which have potential to raise income and bolster food security, are an important but understudied route through which to sustainably improve nutritional and HIV outcomes in SSA, including Kenya where agriculture accounts for > 75% of the total workforce, and 51% of the gross domestic product.[22]

Building on the investigators successful completion of the pilot intervention trial in Kenya and the investigators collective experience studying structural barriers to HIV care in SSA, the investigators plan to test the hypothesis that a multisectoral agricultural and microcredit loan intervention will improve food security, prevent ART treatment failure, and reduce co-morbidities among PLHIV. The investigators' intervention was co-developed with KickStart, a prominent non-governmental organization (NGO) based in SSA that has introduced a human-powered pump, enabling farmers to grow high yield crops year-round. This technology has reduced food insecurity and poverty for 800,000 users in 22 countries in the subcontinent since 1991.[23] The investigators' 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. This study is a cluster randomized controlled trial (RCT) of this intervention with the following specific aims:

Aim 1: To determine the impact of a multisectoral agricultural intervention among HIV-infected farmers on ART on HIV clinical outcomes. The investigators hypothesize that the intervention will lead to improved viral load suppression (primary outcome) and changes in CD4 cell count, physical health status, WHO stage III/IV disease, and hospitalizations (secondary outcomes) in the intervention arm compared to the control arm.

Aim 2: To understand the pathways through which the multisectoral intervention may improve HIV health outcomes. Using the investigator's theoretical model,[1,24] the investigators hypothesize that the intervention will improve food security and household wealth, which in turn will contribute to improved outcomes through nutritional (improved nutritional status measured with Body Mass Index), behavioral (improved ART adherence, and retention in care), and mental health (improved mental health/less depression, improved empowerment) pathways (secondary outcomes).

Aim 3: To determine the cost-effectiveness of the intervention and obtain the information necessary to inform scale-up in Kenya and similar settings in SSA. The investigators will quantify the cost per disability-adjusted life year averted, and identify lessons to inform successful scale-up.

To accomplish Aims 1 & 2, the investigators will randomize 8 matched pairs of health facilities in the Nyanza Region in a 1:1 ratio to the intervention and control arms, and enroll 44 participants per facility (total n=704). All participants will be followed for 2 years. Impacts of the investigator's intervention on primary health outcomes and mediators will be investigated to provide definitive data of direct and indirect intervention effects. To accomplish Aim 3, the investigators will: a) conduct a cost-effectiveness analysis; b) identify the characteristics of individuals most likely to benefit from the intervention (e.g., gender, educational attainment, family size, wealth, risk tolerance, and entrepreneurial ability); and c) perform a mixed-methods process evaluation with study participants, staff, and various stakeholders to determine what worked and did not work to guide future scale-up efforts of the intervention.

The investigator's ultimate goal is to develop and test an intervention to reverse the cycle of food insecurity and HIV/AIDS morbidity and mortality in SSA.

Study Type

Interventional

Enrollment (Actual)

746

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Hongo Ogosa
      • Kisumu, Kenya
        • Kisumu District Hospital
      • Kisumu, Kenya
        • Lumumba
      • Kisumu, Kenya
        • Nyangande
      • Kisumu, Kenya
        • Pandiperi
      • Kisumu, Kenya
        • Railways
      • Migori, Kenya
        • Osingo
      • Migori, Kenya
        • Suna Ragana
    • Homa Bay
      • Suba, Homa Bay, Kenya
        • Kitare
      • Suba, Homa Bay, Kenya
        • Sindo
    • Migori
      • Nyatike, Migori, Kenya
        • Muhuru Bay
      • Nyatike, Migori, Kenya
        • Sori Lakeside
      • Rongo, Migori, Kenya
        • Minyenya
      • Rongo, Migori, Kenya
        • Ngode
      • Rongo, Migori, Kenya
        • Oyani
      • Uriri, Migori, Kenya
        • Nyamasare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants in the control arm will receive the standard of care.
Experimental: Intervention
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
A) A loan (~$175) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
Time Frame: Baseline and endline (2 years after enrollment)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e., linear trend) from baseline to the end of follow-up (2 years) of the proportion of participants with a CD4 cell count <=500 cells/mm^3, compared between study groups using difference-in-differences analyses.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Physical Health Status
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean physical health score compared between study groups using the differences-in-differences analyses. We used the Medical Outcomes Study HIV Health Survey (MOS-HIV), a tool used to assess health-related quality of life that has been validated in resource-limited settings. Scores standardized to a range of 0 to 100. Higher scores mean a better outcome.
Baseline and endline (2 years after enrollment)
Change (i.e., Linear Trend) in the Mean Number of Patients With AIDS-Defining Condition
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e., linear trend) from baseline to the end of follow-up (2 years) of the mean number of participants with an AIDS-defining condition, compared between study groups using difference-in-differences analyses. AIDS-defining conditions including HIV-related illnesses included in the Centers for Disease Control and Prevention's (CDC) list of diagnostic criteria for AIDS. AIDS-defining conditions include opportunistic infections and cancers that are life-threatening in a person with HIV.
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
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to end of follow-up (2 years) of the proportion of participants hospitalized in the previous 6 months (yes/no), compared between study groups using difference-in-differences analyses.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score
Time Frame: Baseline and endline (2 years after enrollment)

The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean household food insecurity score, compared between study groups using difference-in-differences analyses.

using the Household Food Insecurity Access Scale (HFIAS). The HFIAS is a tool to assess household food insecurity (access). The scale scores range from 0 to 27, with higher scores indicating greater food insecurity.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI))
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean body mass index (BMI) compared between study grouops using the differences-in-differences analyses.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) of the mean self-reported adherence to antiretroviral therapy compared between study groups using the differences-in-differences analyses.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Mean Self-confidence Score
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear tend) from baseline to the end of follow-up (2 years) in the mean self-confidence score, compared between study groups using difference-in-differences analyses. Self-confidence is measured using the three-item Power Within scale, which has a range of 3 to 9 points where lower scores indicate greater self-confidence.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in Proportion of Probable Depression
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) in the proportion with probable depression using the Hopkins Symptom Check-list for Depression, compared between study groups using difference-in-differences analyses.
Baseline and endline (2 years after enrollment)
Change (i.e. Linear Trend) in the Mean Internalized Stigma Score
Time Frame: Baseline and endline (2 years after enrollment)
The outcome was the change (i.e. linear trend) from baseline to the end of follow-up (2 years) in the mean internalized stigma score compared between study groups using the differences-in-differences analyses. Internalized HIV stigma arises when someone has accepted and endorsed the negative attitudes towards her/himself due to their HIV status. The internalized HIV stigma sub-scale consisted of six items asking respondents to agree with statements related to how they feel about being HIV positive, such as "having HIV makes me feel like I'm a bad person" and "I feel ashamed of having HIV." Response options ranged from 1 "strongly disagree" to 5 "strongly agree." During the analysis phase, the composite scores of each stigma sub-scale were rescaled to a row average of 1-5, with higher scores indicating greater stigma.
Baseline and endline (2 years after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Mental Health (NIMH)
University of Pennsylvania
University of South Carolina
University of Connecticut
Kenya Medical Research Institute

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimated)

June 28, 2016

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P0503135
  • R01MH107330-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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