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Changing Health Through Food Support (CHEFS) Program (CHEFS)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medically-appropriate meals and groceries
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring food insecurity, community-based, food assistance, food support, intervention, medically tailored, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    June 7, 2017
    Last Updated
    March 7, 2022
    Sponsor
    University of California, San Francisco
    Collaborators
    Project Open Hand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03191253
    Brief Title
    Changing Health Through Food Support (CHEFS) Program
    Acronym
    CHEFS
    Official 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 6, 2016 (Actual)
    Primary Completion Date
    September 28, 2017 (Actual)
    Study Completion Date
    September 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    Project Open Hand

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS
    Keywords
    food insecurity, community-based, food assistance, food support, intervention, medically tailored, nutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    191 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day.
    Intervention Type
    Other
    Intervention Name(s)
    Medically-appropriate meals and groceries
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group
    Description
    Nondetectable HIV viral load
    Time Frame
    Assessed at baseline and 6 months
    Title
    Change from baseline health-related quality of life at 6 months in the intervention compared to the control group
    Description
    Short-form SF-36, a validated tool to assess health-related quality of life
    Time Frame
    Assessed at baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline depression at 6 months in the intervention compared to the control group
    Description
    Patient Health Questionnaire (PHQ-9), a validated tool to diagnose the severity of depression
    Time Frame
    Assessed at baseline and 6 months
    Title
    Change from baseline ART adherence at 6 months in the intervention compared to the control group
    Description
    Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV
    Time Frame
    Assessed at baseline and 6 months
    Title
    Change from baseline diet quality at 6 months in the intervention compared to the control group
    Description
    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
    Time Frame
    Assessed at baseline and 6 months
    Title
    Change from baseline food security at 6 months in the intervention compared to the control group
    Description
    U.S. Household Food Security Survey (HFSS), a validated tool to assess food insecurity
    Time Frame
    Assessed at baseline and 6 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan to share individual participant data.
    Citations:
    PubMed Identifier
    28097614
    Citation
    Palar K, Napoles T, Hufstedler LL, Seligman H, Hecht FM, Madsen K, Ryle M, Pitchford S, Frongillo EA, Weiser SD. Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017 Feb;94(1):87-99. doi: 10.1007/s11524-016-0129-7.
    Results Reference
    background
    PubMed Identifier
    27771206
    Citation
    Whittle HJ, Palar K, Seligman HK, Napoles T, Frongillo EA, Weiser SD. How food insecurity contributes to poor HIV health outcomes: Qualitative evidence from the San Francisco Bay Area. Soc Sci Med. 2016 Dec;170:228-236. doi: 10.1016/j.socscimed.2016.09.040. Epub 2016 Oct 19.
    Results Reference
    background
    PubMed Identifier
    27637497
    Citation
    Weiser SD, Hatcher AM, Hufstedler LL, Weke E, Dworkin SL, Bukusi EA, Burger RL, Kodish S, Grede N, Butler LM, Cohen CR. Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention. AIDS Behav. 2017 Feb;21(2):415-427. doi: 10.1007/s10461-016-1551-2.
    Results Reference
    background
    PubMed Identifier
    26990632
    Citation
    Palar K, Laraia B, Tsai AC, Johnson MO, Weiser SD. Food insecurity is associated with HIV, sexually transmitted infections and drug use among men in the United States. AIDS. 2016 Jun 1;30(9):1457-65. doi: 10.1097/QAD.0000000000001095.
    Results Reference
    background
    PubMed Identifier
    26546789
    Citation
    Whittle HJ, Palar K, Napoles T, Hufstedler LL, Ching I, Hecht FM, Frongillo EA, Weiser SD. Experiences with food insecurity and risky sex among low-income people living with HIV/AIDS in a resource-rich setting. J Int AIDS Soc. 2015 Nov 4;18(1):20293. doi: 10.7448/IAS.18.1.20293. eCollection 2015.
    Results Reference
    background
    PubMed Identifier
    26356827
    Citation
    Whittle HJ, Palar K, Hufstedler LL, Seligman HK, Frongillo EA, Weiser SD. Food insecurity, chronic illness, and gentrification in the San Francisco Bay Area: An example of structural violence in United States public policy. Soc Sci Med. 2015 Oct;143:154-61. doi: 10.1016/j.socscimed.2015.08.027. Epub 2015 Aug 20.
    Results Reference
    background
    PubMed Identifier
    25096896
    Citation
    Singer AW, Weiser SD, McCoy SI. Does Food Insecurity Undermine Adherence to Antiretroviral Therapy? A Systematic Review. AIDS Behav. 2015 Aug;19(8):1510-26. doi: 10.1007/s10461-014-0873-1.
    Results Reference
    background
    PubMed Identifier
    23086429
    Citation
    Vogenthaler NS, Kushel MB, Hadley C, Frongillo EA Jr, Riley ED, Bangsberg DR, Weiser SD. Food insecurity and risky sexual behaviors among homeless and marginally housed HIV-infected individuals in San Francisco. AIDS Behav. 2013 Jun;17(5):1688-93. doi: 10.1007/s10461-012-0355-2.
    Results Reference
    background
    PubMed Identifier
    22089434
    Citation
    Weiser SD, Young SL, Cohen CR, Kushel MB, Tsai AC, Tien PC, Hatcher AM, Frongillo EA, Bangsberg DR. Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS. Am J Clin Nutr. 2011 Dec;94(6):1729S-1739S. doi: 10.3945/ajcn.111.012070. Epub 2011 Nov 16.
    Results Reference
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