HIV/AIDS
Conditions
Keywords
food insecurity, community-based, food assistance, food support, intervention, medically tailored, nutrition
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.
Interventions
OTHERMedically-appropriate meals and groceries
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.
Sponsors
Project Open Hand
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 |
Outcome results
None listed