Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 746
- 试验地点
- 16
- 主要终点
- Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Proportion of Viral Load Suppression (<=200 Copies/mL)
时间窗: 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.
次要结局
- Change (i.e. Linear Trend) in Mean Self-reported Adherence to Antiretroviral Therapy(Baseline and endline (2 years after enrollment))
- 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 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))
- Change (i.e. Linear Trend) in Mean Self-confidence Score(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 Mean Nutritional Status (Represented by Body Mass Index (BMI))(Baseline and endline (2 years after enrollment))
- Change (i.e. Linear Trend) in Proportion of Probable Depression(Baseline and endline (2 years after enrollment))
- Change (i.e. Linear Trend) in the Mean Internalized Stigma Score(Baseline and endline (2 years after enrollment))
