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临床试验/NCT03568682
NCT03568682已完成不适用

Improving ART Adherence Through Urban Gardening and Peer Nutritional Counseling in the Dominican Republic

RAND2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2018年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
115
试验地点
2
主要终点
Change in viral load

研究概览

简要总结

This pilot study proposes to develop, implement, and evaluate the feasibility, acceptability and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer nutrition counseling with sustainable urban gardening among people with HIV in the Dominican Republic. The overall hypothesis is that this combined intervention will improve adherence to antiretroviral therapy (ART) and virologic suppression among food insecure HIV+ individuals with suboptimal adherence.

详细描述

The purpose of this pilot clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a culturally appropriate, multi-component intervention that targets food insecurity and nutritional health with the ultimate goal of improving antiretroviral therapy adherence and virologic suppression for people with HIV in the Dominican Republic. Through an initial phase, we conducted formative research on dietary patterns and locally available foods and, together with our preliminary research on nutritional counseling and urban gardening, developed a multi-component nutrition intervention to address food insecurity among people with HIV that integrates culturally-appropriate, peer-led nutritional education with a sustainable urban garden component. During the clinical trial phase, we will enroll 120 HIV+ adults with food insecurity and suboptimal adherence in 2 HIV clinics (60 participants in the intervention clinic and 60 participants in the control clinic) and will evaluate the feasibility, acceptability and preliminary effectiveness of urban gardening plus peer nutritional counseling on improving virologic suppression and ART adherence in both the short (month 6) and longer terms (month 12). We will also explore preliminary intervention effects on potential mediators (food security, nutritional status, internalized HIV stigma, and social support). As one of the first studies to develop a sustainable food production approach with peer nutrition counseling among people with HIV, key products will include: 1) an easy-to-use peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on the feasibility, acceptability, and effects of our intervention on primary outcomes and potential mediators; and 3) if results are promising, an R01 application to conduct a fully-powered cluster randomized controlled trial that examines effects across a larger number of clinics in the Dominican Republic.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV+ and on ART
  • Has moderate or severe household food insecurity
  • Has detectable viral load (>50 copies) and/or suboptimal adherence to ART

排除标准

  • Does not meet above criteria

结局指标

主要结局

Change in viral load

时间窗: Change in viral load between baseline and months 6 and 12

Change in viral load

次要结局

  • Antiretroviral therapy adherence(Months 6 and 12)
  • HIV care retention(Months 6 and 12)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn Derose

Senior Policy Researcher

RAND

研究点 (2)

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