Changing Health Through Food Support (CHEFS) Program

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Other: Medically-appropriate meals and groceries

• Registration Number: NCT03191253
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Primary Completion: 2017-09-28
• Study Completion: 2017-09-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Medically-appropriate meals and groceries	The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education.

Primary Outcome Measures

Name	Time	Method
Change from baseline health-related quality of life at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	Short-form SF-36, a validated tool to assess health-related quality of life
Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	Nondetectable HIV viral load

Secondary Outcome Measures

Name	Time	Method
Change from baseline ART adherence at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV
Change from baseline food security at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	U.S. Household Food Security Survey (HFSS), a validated tool to assess food insecurity
Change from baseline diet quality at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	18-items adapted from National Cancer Institute Multifactor Screener, a validated tool to assess approximate intakes of fruits, vegetables, fats, proteins, dairy, grains, and sugars
Change from baseline depression at 6 months in the intervention compared to the control group	Assessed at baseline and 6 months	Patient Health Questionnaire (PHQ-9), a validated tool to diagnose the severity of depression