Changing Health Through Food Support (CHEFS) Program

N/ACompletedNCT03191253

University of California, San Francisco191 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

191

Conditions

HIV/AIDS

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group

Nondetectable HIV viral load