Clinical trial NCT03191253: Changing Health Through Food Support (CHEFS) Program
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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: food insecurity
community-based
food assistance
food support
intervention
medically tailored
nutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Project Open Hand
First posted: 2017-06-19
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
measure: Change from baseline health-related quality of life at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
Secondary outcomes:
measure: Change from baseline depression at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
measure: Change from baseline ART adherence at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
measure: Change from baseline diet quality at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
measure: Change from baseline food security at 6 months in the intervention compared to the control group
timeFrame: Assessed at baseline and 6 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.