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| Name | Class |
|---|---|
| Project Open Hand | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education. |
|
| Control | No Intervention | The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group | Nondetectable HIV viral load | Assessed at baseline and 6 months |
| 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 | Assessed at baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at baseline and 6 months |
| Change from baseline ART adherence at 6 months in the intervention compared to the control group |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097614 | Background | 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. | |
| 27771206 | Background |
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We do not plan to share individual participant data.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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).
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|
Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV |
| Assessed at baseline and 6 months |
| 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 | Assessed at baseline and 6 months |
| 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 | Assessed at baseline and 6 months |
| 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. |
| 27637497 | Background | 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. |
| 26990632 | Background | 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. |
| 26546789 | Background | 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. |
| 26356827 | Background | 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. |
| 25096896 | Background | 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. |
| 23086429 | Background | 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. |
| 22089434 | Background | 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. |
| 38696724 | Derived | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |