Changing Health Through Food Support (CHEFS): Pilot RCT to Identify Potential Health Impacts of Providing Comprehensive, Medically-appropriate Food Support to Low-income Urban Adults Living With HIV (PLHIV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 主要终点
- Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group
研究概览
简要总结
UCSF and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct an initial randomized controlled trial (RCT) of the Changing Health through Food Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing comprehensive, medically-appropriate food support, individual nutritional counseling, and group-based nutritional education over 6 months to low-income clients who have been diagnosed with HIV in order to improve their viral load and health-related quality of life (primary outcomes) as well as depression, ART adherence, food security and diet quality (secondary outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100). Participants will be followed for 6 months. The investigators will assess outcomes at baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the investigators will conduct a qualitative study at follow-up in a subset of participants to understand perceived impacts, barriers and facilitators.
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
- 否
入选标准
- •HIV positive
- •Income at or below 200% FPL (~$2400/month)
- •30-50% minimum POH regular program adherence level (i.e. regular service access rate)
- •Are willing and able to eat food from POH based on one of POH's regularly available diet choices (including regular, non-dairy, vegetarian, vegetarian non-dairy, diabetic, and bland), excluding the renal diet.
- •Have access to a refrigerator or freezer with sufficient space to store perishable food provided by POH, and have access to an appliance to reheat food.
排除标准
- •Do not speak Spanish or English
- •Do not have adequate cognitive or hearing capacity to complete interviews
- •Have a history of violent behavior at POH (such as verbal or physical abuse to other clients and/or staff)
- •Have renal disease requiring a special renal diet
- •Have severe food allergies
- •Currently pregnant or <6 months post-partum
- •Unable to complete an interview due to a health condition
- •Unable or unwilling to eat food from POH (based on one of POH's regularly available diet choices)
- •Among people who share a household (such as partners, family members, or roommates), only one may be involved in the study.
结局指标
主要结局
Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group
时间窗: Assessed at baseline and 6 months
Nondetectable HIV viral load
Change from baseline health-related quality of life at 6 months in the intervention compared to the control group
时间窗: Assessed at baseline and 6 months
Short-form SF-36, a validated tool to assess health-related quality of life
次要结局
- Change from baseline ART adherence at 6 months in the intervention compared to the control group(Assessed at baseline and 6 months)
- Change from baseline food security at 6 months in the intervention compared to the control group(Assessed at baseline and 6 months)
- Change from baseline diet quality at 6 months in the intervention compared to the control group(Assessed at baseline and 6 months)
- Change from baseline depression at 6 months in the intervention compared to the control group(Assessed at baseline and 6 months)