Changing Health Through Food Support (CHEFS) Program

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV/AIDS

Treatments: Other: Medically-appropriate meals and groceries

Study type: Interventional

Funder types: Other

Identifiers

NCT03191253

P0515916

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Medically-appropriate meals and groceries

Control

No Intervention group

Description:

The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day.