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临床试验/NCT01548599
NCT01548599已完成不适用

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

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year

研究概览

简要总结

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.

详细描述

Food insecurity and HIV/AIDS are two leading causes of morbidity and mortality in sub-Saharan Africa and are inextricably linked. Since food insecurity contributes to increased HIV transmission risk and higher HIV-related morbidity and mortality, the World Health Organization (WHO), United Nations Programme on HIV/AIDS (UNAIDS), and the World Food Programme have recommended integrating sustainable food production strategies into HIV/AIDS programming. Yet, to date there have been few studies to systematically evaluate the impact of promising food security interventions on health, economic and behavioral outcomes among people living with HIV and AIDS. To address this gap, the investigators plan to test the hypothesis that a multi-sectoral agricultural intervention delivered in Nyanza Province, Kenya will prevent highly active antiretroviral (HAART) treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk. 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. To develop our intervention, th investigators have formed an interdisciplinary collaboration with organizations in the healthcare, agriculture, and microfinance sectors. Our study aims include:

  1. The investigators will operationalize and pilot test key design elements of a future cluster randomized clinical trials (RCT) aimed to improve health outcomes among HAART-treated patients in Western Kenya. In conjunction with our collaborating partners, the investigators will develop the different components of the intervention, including: a) randomization procedures for cluster RCT using detailed site assessments; b) agricultural training protocols; c) procedures for control group; d) manual of operations.
  2. The investigators will conduct a pilot study of an agricultural intervention to determine the preliminary impact of the intervention on mediating outcomes (food security, and household economic indicators), and on primary health outcomes of interest for the planned RCT (HIV treatment outcomes, HIV transmission risk and women's empowerment). Up to one hundred and sixty HIV-infected farmers on HAART in Western Kenya (80 at an intervention clinic and 80 at a control clinic) will be enrolled and followed for 1 year. Impacts of our intervention on mediating and primary health outcomes will be investigated separately and jointly to provide a preliminary assessment of possible direct and indirect intervention effects.
  3. The investigators will assess the acceptability and feasibility of intervention and control conditions, and systematically translate lessons learned in the pilot study into the design of a cluster RCT. To accomplish Aim 3, the investigators will conduct a mixed methods process evaluation of the different intervention components and their implementation using quantitative, qualitative, and observational methods. The investigators will prepare an R01 grant for submission based on lessons learned. The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa.

The ultimate goal of this work is to contribute to sustainable solutions to tackle the intersecting challenges of food insecurity, poverty, and HIV/AIDS in sub-Saharan Africa.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-infected
  • 18-49 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.

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year

时间窗: 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.

Change From Baseline in CD4 Count at 1 Year

时间窗: 1 year

Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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