Changing Health Through Food Support (CHEFS) Program

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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HIV/AIDS

Intervention / Treatment
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* Other: Medically-appropriate meals and groceries


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will randomize 200 participants to the intervention (n=100) or control (n=100). 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education. | Other: Medically-appropriate meals and groceries<br>* Full nutrition Intervention Components: (1) 7 pre-packaged frozen meals; (2) Groceries or another 7-pack of meals; (3) Nutritional supplement bag to round out the nutrition in terms of nutrients, or dietary reference intakes (DRIs), and number of servings from fruits/vegetables, whole grains, legumes, nuts/seeds and dairy. The nutritional supplemental bag will also contain bulk ingredients to aid in cooking e.g., cooking oil, spices, and herbs as well as bulk items e.g., jar of peanut butter, quart of milk; (4) Individual nutritional counseling (x2 sessions); and (5) Group nutrition education classes (X3 classes) by POH registered dietitian (RD) team.<br>|
| No Intervention: Control<br>The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline depression at 6 months in the intervention compared to the control group | Patient Health Questionnaire (PHQ-9), a validated tool to diagnose the severity of depression | Assessed at baseline and 6 months | 
| Change from baseline ART adherence at 6 months in the intervention compared to the control group | Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV | Assessed at baseline and 6 months | 
| Change from baseline diet quality at 6 months in the intervention compared to the control group | 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 | Assessed at baseline and 6 months | 
| Change from baseline food security at 6 months in the intervention compared to the control group | U.S. Household Food Security Survey (HFSS), a validated tool to assess food insecurity | Assessed at baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, food insecurity, community-based, food assistance, food support, medically tailored, nutrition