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HIV/AIDSCHEFSNCT03191253

Changing Health Through Food Support (CHEFS) Program

A study testing Medically-appropriate meals and groceries in people with HIV/AIDS, run by University of California, San Francisco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS
What is being tested?
Medically-appropriate meals and groceries
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
No sites listed yet
Study dates
6 Jul 2016to 28 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

About this study

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)

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.

Conditions
HIV/AIDS
Being tested
Medically-appropriate meals and groceries
Keywords
food insecurity, community-based, food assistance, food support, intervention, medically tailored, nutrition
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medically-appropriate meals and groceriesOther

    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.

Study groups in NCT03191253
Study groupRoleWhat they receive
InterventionExperimentalThe intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education.
Receives: Other: Medically-appropriate meals and groceries
ControlNo interventionThe control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Nondetectable HIV viral load

    Measured: Assessed at baseline and 6 months

  2. 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

    Measured: Assessed at baseline and 6 months

Secondary outcomes (4)

  1. 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

    Measured: Assessed at baseline and 6 months

  2. 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

    Measured: Assessed at baseline and 6 months

  3. 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

    Measured: Assessed at baseline and 6 months

  4. 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

    Measured: Assessed at baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start6 Jul 2016
  3. Primary completion28 Sep 2017
  4. Study completion28 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191253
Sponsor's protocol ID
P0515916
Acronym
CHEFS
Status last verified
Mar 2022
First submitted
7 Jun 2017
Last updated
21 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share individual participant data.

Publications

  • 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.

    PubMed 28097614

  • 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.

    PubMed 27771206

  • 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.

    PubMed 27637497

  • 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.

    PubMed 26990632

  • 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.

    PubMed 26546789

  • 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.

    PubMed 26356827

  • 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.

    PubMed 25096896

  • 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.

    PubMed 23086429

  • 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.

    PubMed 22089434

  • Palar K, Sheira LA, Frongillo EA, O'Donnell AA, Napoles TM, Ryle M, Pitchford S, Madsen K, Phillips B, Riley ED, Weiser SD. Food Is Medicine for Human Immunodeficiency Virus: Improved Health and Hospitalizations in the Changing Health Through Food Support (CHEFS-HIV) Pragmatic Randomized Trial. J Infect Dis. 2025 Mar 17;231(3):573-582. doi: 10.1093/infdis/jiae195.

    PubMed 38696724

Questions about this trial

What is this clinical trial studying?

A study testing Medically-appropriate meals and groceries in people with HIV/AIDS, run by University of California, San Francisco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191253, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022; AzTrials last refreshed its copy on 28 Oct 2026.

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