Clinical trial NCT02815579: Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Official title: Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Food insecurity
Microcredit loan
Agriculture
Livelihoods
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenya Medical Research Institute
name: University of South Carolina
name: University of Connecticut
name: University of Pennsylvania
First posted: 2016-06-28
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
timeFrame: Baseline and endline (2 years after enrollment)
Secondary outcomes:
measure: Change (i.e., Linear Trend) in Proportion of Absolute CD4 Count <=500 Cells/mm^3
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in Mean Physical Health Status
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e., Linear Trend) in the Proportion of Participants With AIDS-Defining Condition
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e., Linear Trend) in the Proportion of Participants Who Were Hospitalized in the Previous 6 Months
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in the Mean Score of Food Insecurity Score
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in Mean Nutritional Status (Represented by Body Mass Index (BMI))
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in Mean Self-confidence Score
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in Proportion of Probable Depression
timeFrame: Baseline and endline (2 years after enrollment)
measure: Change (i.e. Linear Trend) in the Mean Internalized Stigma Score
timeFrame: Baseline and endline (2 years after enrollment)
Other outcomes:
Locations:
city: Suba
country: Kenya
facility: Kitare
state: Homa Bay
city: Suba
country: Kenya
facility: Sindo
state: Homa Bay
city: Nyatike
country: Kenya
facility: Muhuru Bay
state: Migori
city: Nyatike
country: Kenya
facility: Sori Lakeside
state: Migori
city: Rongo
country: Kenya
facility: Minyenya
state: Migori
city: Rongo
country: Kenya
facility: Ngode
state: Migori
city: Rongo
country: Kenya
facility: Oyani
state: Migori
city: Uriri
country: Kenya
facility: Nyamasare
state: Migori
city: Kisumu
country: Kenya
facility: Hongo Ogosa
city: Kisumu
country: Kenya
facility: Kisumu District Hospital
city: Kisumu
country: Kenya
facility: Lumumba
city: Kisumu
country: Kenya
facility: Nyangande
city: Kisumu
country: Kenya
facility: Pandiperi
city: Kisumu
country: Kenya
facility: Railways
city: Migori
country: Kenya
facility: Osingo
city: Migori
country: Kenya
facility: Suna Ragana
Study officials:
affiliation: Departments of Medicine, UCSF
name: Sheri D Weiser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, UCSF
name: Craig R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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