A clinical trial has found that medically-tailored meals and groceries, combined with nutritional education, can reduce hospitalisations and improve mental and physical health in people with HIV. However, the intervention did not yield any improvement in terms of unsuppressed viral load, according to the report in the Journal of Infectious Diseases.
The “Changing Health through Food Support for HIV Study” (CHEFS-HIV) was conducted by Dr Kartika Palar from the University of California San Francisco (UCSF), in partnership with Project Open Hand, a non-for-profit nutrition agency based in the San Francisco Bay area. The trial compared an intensive medically-tailored intervention matching food support with health and medical needs – a “Food is medicine” approach – to standard of care food services provided by Project Open Hand. The study investigated whether or not this intervention could help to reduce viral non-suppression among participants, as a primary outcome. It also explored the impact of “Food is medicine” on the following secondary outcomes: food security, symptoms of depression, adherence to antiretroviral therapy, hospitalisations and how many times participants had had condomless sex in the last three months.
Several reasons brought Palar and colleagues to conduct the CHEFS-HIV Study. Among people with HIV, food insecurity in high-income countries is associated with poor quality diets, mental health challenges, sexual risk behaviour, less adherence to antiretroviral therapy, lower CD4 cell counts, higher viral load and increased mortality. Furthermore, both food insecurity and HIV disproportionately affect low-income and ethnic minorities.
The investigators had previously evaluated the “Food is medicine” approach with a pilot study of 52 people with HIV and/or diabetes, resulting in improvements in food security, symptoms of depression and antiretroviral adherence. However, as this study was small, had no control arm and did not assess viral load, its results warranted a more thorough investigation.
The CHEFS-HIV Study recruited 191 participants in 2016-2017. HIV-positive clients of Project Open Hand could participate if they were at least eighteen years old, spoke English or Spanish, had the ability to store and reheat perishable food, and had a household income lower than 200% of the US federal poverty level, reflecting food insecurity (for a single person at the time of the study, income would have been below $23,760).
Ninety-three participants were assigned to the intervention arm, which provided “Food is medicine” for six months:
- Medically-tailored meals and groceries, equivalent to three meals a day, designed to meet all daily energy requirements (based on an average of 1965-2359 calories/day). Importantly, the food plan varied each week, was low in refined sugars and saturated fats, and contained fresh fruit and vegetables, lean proteins, healthy fats and whole grains. A grocery bag was provided as additional to meals, to ensure that all food groups and daily nutrients were included. The intervention was informed by guidelines from the American Diabetes Association and the American Heart Association.
- Nutritional education: one individual nutritional counselling session at the start of the study (baseline) and another towards the end, one assessment call at 3 months and three 2-hour small group nutrition classes covering HIV, nutrition, portion size, food labels, goal setting and cooking demonstrations.
The other 98 participants were assigned to the control arm consisting of receiving groceries or prepared meals sufficient for one or two meals a day, and meeting briefly with Project Open Hand dietitians every six months, but with no nutritional education.
Outcomes were measured at baseline and at six-month follow-up through blood tests and a standard quality-of-life self-reporting questionnaire (the SF-36), whose highest score is 90.
Results
Most participants were men aged fifty years and over. Most were from ethnic minority backgrounds, with an education level superior to high-school. Many (30%) had used illicit drugs in the past 30 days and had a self-reported mental health diagnosis (60%). Median time since HIV diagnosis was twenty-two years. Forty per cent had diabetes, hypertension or cardiovascular disease.
At baseline, viral load was unsuppressed in 36% and the mean quality of life score was 52.4. Almost two thirds of participants (63%) were food insecure, 46% had symptoms of depression, 22% missed more than one in ten antiretroviral doses, 8% had had an overnight hospitalisation in the past three months, and 61% had had condomless sex in the same period.
After six-months, 168 participants (88%) remained in the study, which is a high retention rate in this setting. Retention was similar in both arms.
While the rates of unsuppressed viral load decreased in each arm – probably due to intensified local outreach and services at the time – no significant differences between the two arms were found for this parameter at six months. Neither were there differences in terms of quality of life.
However, the risk of becoming severely food insecure among the “Food is medicine” participants was reduced by 77% over six months (odds ratio 0.23, [95% confidence interval, 0.87-6.17]), when compared to the control arm participants. Also, the risk of severe symptoms of depression was reduced by 68% (OR, 0.32, [95% CI, 0.125-0.834]). A greater decrease in fatty food consumption was noted, but there was no difference between arms regarding fruit and vegetable consumption.
In the “Food is medicine” arm, rates of poor antiretroviral therapy adherence were lower (OR, 0.18, [95% CI, .0389-.821]), as were rates of condomless sex (OR, 0.05 [95% CI, .00385-.528]). Finally, the proportion of participants hospitalised in the past three months decreased from 11% to 5% among “Food is medicine” recipients, while increasing from 6% to 11% in the control arm – which translates to a significant 89% lower risk of hospitalisations (OR, 0.11 [95% CI, .0134-.960]) in the intervention arm.
Conclusion
Palar and colleagues argue that “Food is medicine” programmes can improve physical and mental health outcomes in people living with HIV. They also highlight the positive impact of their programme on sexual behaviour, which confirms the well-documented link between food insecurity and risky sexual behaviour, for example when transactional sex occurs. Explaining the programme’s impact on hospitalisations, they point out that social factors linked to food insecurity such as homelessness and illicit drug use are major contributors to emergency department use, hospitalisation and death in San Francisco.
In an accompanying Journal of Infectious Diseases commentary, Dr Seth Berkowitz from Johns Hopkins University also stresses the importance of the decline in hospital admissions, but doesn’t view it, as is often the case, from the sole perspective of economics. “A reduction in hospitalisations can be seen as an indicator of improved health,” he says.
Berkowitz praises the CHEFS-HIV study, but reminds us that it should be considered in a broader social context. “Food is medicine” efforts are attempts to mitigate the consequences of adverse social circumstances, but do not confront the social injustice that creates them in the first place. Doing so would require more focus on reforming the social institutions which distribute power and resources in the US.
Palar K et al. Food Is Medicine for Human Immunodeficiency Virus: Improved Health and Hospitalizations in the Changing Health Through Food Support (CHEFS-HIV) Pragmatic Randomized Trial. The Journal of Infectious Diseases, jiae195, online ahead of print 2 May 2024.
https://doi.org/10.1093/infdis/jiae195
Berkowitz et al. The Benefits of Medically Tailored Meals for People With Human Immunodeficiency Virus. The Journal of Infectious Diseases, jiae 196, online ahead of print 2 May 2024