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Completed

NCT Number: NCT03191253

Changing Health Through Food Support (CHEFS) Program

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medically-appropriate meals and groceries

Other

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.

Primary outcomes

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

    Time frame: Assessed at baseline and 6 months

    Nondetectable HIV viral load

  2. Change from baseline health-related quality of life at 6 months in the intervention compared to the control group

    Time frame: Assessed at baseline and 6 months

    Short-form SF-36, a validated tool to assess health-related quality of life

Secondary outcomes

  1. Change from baseline depression at 6 months in the intervention compared to the control group

    Time frame: Assessed at baseline and 6 months

    Patient Health Questionnaire (PHQ-9), a validated tool to diagnose the severity of depression

  2. Change from baseline ART adherence at 6 months in the intervention compared to the control group

    Time frame: Assessed at baseline and 6 months

    Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV

  3. Change from baseline diet quality at 6 months in the intervention compared to the control group

    Time frame: 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

  4. Change from baseline food security at 6 months in the intervention compared to the control group

    Time frame: Assessed at baseline and 6 months

    U.S. Household Food Security Survey (HFSS), a validated tool to assess food insecurity

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Project Open Hand

Registry information

Official study title

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)

Acronym: CHEFS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2017
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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