Bilingual Intervention for HIV/AIDS-Related Food Insecurity

Overseen By Lisa Norfleet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how food insecurity (not having enough food) affects heart and metabolic health in people living with HIV. Researchers are testing a new bilingual program called weCare/Secure, which aims to reduce these health issues by offering support through peer navigation and mobile health tools. Participants will either receive this new intervention or continue with their usual care (Standard Care or Conventional Care). This trial is for patients at the Wake Forest Infectious Diseases Specialty Clinic who are living with HIV and can speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for improving health outcomes in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for people with HIV?

Research shows that the weCare intervention, part of the weCare/Secure treatment, helps people with HIV through peer support and mobile health tools. In a study examining its effects, participants reported no major safety issues, indicating it is generally well-tolerated. The intervention aims to assist people with HIV in attending medical appointments and improving their health. Previous studies have not mentioned any negative effects, offering reassurance to those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the weCare/Secure intervention for HIV/AIDS-related food insecurity because it uniquely combines peer navigation with mobile health (mHealth) technology. Unlike the usual care, which lacks peer navigation, this approach is grounded in social cognitive and empowerment theories to enhance social support. This innovative method aims to reduce missed HIV care appointments and boost viral suppression among people with HIV, particularly those newly diagnosed or out of care. By empowering patients through personalized support and digital tools, weCare/Secure offers a fresh perspective on managing HIV in the context of food insecurity.

What evidence suggests that this bilingual intervention could be effective for reducing cardiometabolic comorbidities in food insecure people with HIV?

Research has shown that up to 50% of people living with HIV struggle to obtain enough nutritious food, which links to worse health outcomes, such as missing doctor appointments and failing to control the virus. In this trial, participants will join one of two groups. The weCare/Secure program, one of the study arms, aims to address these issues by using peer support and mobile health tools to help people access the food they need. Early results suggest that this approach may improve health by encouraging regular doctor visits and better virus control for those with HIV. The program also focuses on individuals at risk of developing health problems like diabetes and shows promise in improving both food access and health management. The other group will receive Usual Care, which does not include peer navigation. ^{1 2 3 4 6}

Who Is on the Research Team?

Scott D Rhodes, PhD

Principal Investigator

Wake Forest Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who are patients at the Wake Forest Infectious Diseases Specialty Clinic. They must understand English or Spanish and be able to give informed consent. People with cognitive impairments that prevent participation cannot join.

Inclusion Criteria

Participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic

Provide informed consent

You have HIV.

Exclusion Criteria

I do not have any cognitive issues that would stop me from participating.

I cannot speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation and evaluation of the weCare/Secure intervention designed to improve insulin sensitivity among food insecure PWH with prediabetes or Type 2 diabetes

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Usual Care
• weCare/Secure

Trial Overview

The study aims to see if a new bilingual intervention called weCare/Secure can reduce cardiometabolic issues linked to food insecurity in people with HIV, compared to usual care provided by the clinic.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

There is no peer navigation within usual care.

Group II: weCare/Secure Active Control 1 Intervention

The weCare intervention is based on the social cognitive and empowerment theories and social support and is currently designed to reduce missed HIV care appointments and increase viral suppression among PWH who are newly diagnosed or out of care through the use of peer navigation and mHealth

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University of North Carolina, Greensboro

Collaborator

Trials

33

Recruited

16,700+

Published Research Related to This Trial

The two-item food security questionnaire (FSQ) demonstrated a strong correlation with a longer six-item FSQ, indicating it is a reliable tool for screening food insecurity among HIV-1 infected patients, based on a study of 49 subjects.

This two-item FSQ showed excellent sensitivity (100%) and a good specificity (78%), making it an effective screening method for identifying food insecurity in clinical settings for individuals living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A valid two-item food security questionnaire for screening HIV-1 infected patients in a clinical setting. Young, J., Jeganathan, S., Houtzager, L., et al.[2019]

A significant 71% of HIV-infected individuals on highly active antiretroviral therapy (HAART) in British Columbia were found to be food insecure, highlighting a critical public health issue in this population.

Factors such as low income, illicit drug use, tobacco smoking, depressive symptoms, and younger age were identified as independent predictors of food insecurity, indicating the need for targeted interventions to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High prevalence of food insecurity among HIV-infected individuals receiving HAART in a resource-rich setting. Anema, A., Weiser, SD., Fernandes, KA., et al.[2011]

Food insecurity affects up to 50% of people living with HIV in the US, leading to lower adherence to antiretroviral therapy and increased risk of serious health issues, including cardiometabolic comorbidities.

The study will test a bilingual peer navigation-mHealth intervention (weCare/Secure) among food-insecure individuals with prediabetes or Type 2 diabetes to see if it improves insulin sensitivity over 6 months, with results expected by fall 2025.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure. Tanner, AE., Palakshappa, D., Morse, CG., et al.[2023]

In a survey of 251 low-income, predominantly Latinx residents in the lower Rio Grande Valley, those with a prior HIV/AIDS diagnosis reported significantly higher levels of food insecurity, with an increase of about 0.67 points compared to those without such a diagnosis.

Younger individuals living with HIV/AIDS experienced even greater food insecurity, suggesting that community programs should focus on addressing food insecurity, particularly for young adults in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between HIV/AIDS and food insecurity at the US-Mexico border: Experiences of low-income patients in the Rio Grande Valley. Tabler, J., Mykyta, L., Nagata, JM.[2021]

A multisectoral agricultural intervention in Kenya improved food security and reduced depression among HIV-positive adults on antiretroviral therapy, with significant increases in self-confidence and social support over 24 months.

While HIV viral suppression rates improved in both the intervention and control groups, the intervention did not show a significant additional effect on viral load suppression, indicating that while agricultural support is beneficial for overall well-being, it may not directly enhance clinical HIV outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. Cohen, CR., Weke, E., Frongillo, EA., et al.[2023]

Food insecurity is linked to increased risk behaviors for HIV transmission and reduced access to HIV treatment, highlighting a critical intersection between nutrition and health outcomes in individuals with HIV/AIDS.

Among those on antiretroviral therapy, food insecurity leads to poorer adherence, lower CD4 cell counts, and decreased survival rates, indicating that addressing food security is vital for improving health and treatment efficacy in HIV/AIDS care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity and HIV/AIDS: current knowledge, gaps, and research priorities. Anema, A., Vogenthaler, N., Frongillo, EA., et al.[2022]

In a study of 347 homeless and marginally housed HIV-infected individuals over a median of 2 years, severe food insecurity was linked to significantly higher odds of hospitalizations (AOR = 2.16) and Emergency Department visits (AOR = 1.71) compared to food-secure individuals.

Even mild to moderate food insecurity was associated with increased healthcare utilization, indicating that addressing food insecurity could be crucial in improving health outcomes and reducing acute care needs for those living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity is associated with greater acute care utilization among HIV-infected homeless and marginally housed individuals in San Francisco. Weiser, SD., Hatcher, A., Frongillo, EA., et al.[2022]

In a study of 346 people living with HIV over a median of 28 months, over half experienced food insecurity, which was significantly linked to increased symptoms of depression.

Severe food insecurity was associated with higher depressive symptom severity and a greater likelihood of probable depression, suggesting that improving access to food security programs could help alleviate depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Insecurity is Longitudinally Associated with Depressive Symptoms Among Homeless and Marginally-Housed Individuals Living with HIV. Palar, K., Kushel, M., Frongillo, EA., et al.[2022]

A qualitative study involving 34 people living with HIV revealed that participation in a medically appropriate food support program led to self-reported improvements in mental health, including better mood and reduced anxiety.

Participants attributed their mental health improvements to factors such as better access to nutritious food, increased social support, and reduced financial stress, highlighting the importance of food security in mental well-being for those living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How food support improves mental health among people living with HIV: A qualitative study. Chayama, KL., Hufstedler, EL., Whittle, HJ., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9743787/

Exploring the consequences of food insecurity and ...

The objectives of this study are to better understand how food insecurity contributes to the development of cardiometabolic comorbidities among PWH.

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researchgate.net

researchgate.net/publication/366203785_Exploring_the_consequences_of_food_insecurity_and_harnessing_the_power_of_peer_navigation_and_mHealth_to_reduce_food_insecurity_and_cardiometabolic_comorbidities_among_persons_with_HIV_protocol_for_de

(PDF) Exploring the consequences of food insecurity and ...

For instance, in our weCare/Secure intervention, which is designed to reduce food insecurity among persons with HIV who are prediabetic or diabetic, we ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36510319/

Exploring the consequences of food insecurity and ...

Background: Food insecurity, or the lack of consistent access to nutritionally adequate and safe foods, effects up to 50% of people living with ...

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frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1133328/full

The impact of food insecurity on receipt of care, retention in ...

In this cross-sectional study of 200 PLWHA, food insecurity was associated with greater odds of non-retention in care and viral non-suppression.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916523025078

Conceptual framework for understanding the bidirectional ...

We have suggested that nutritional, mental health, and behavioral pathways explain how food insecurity affects HIV acquisition and HIV/AIDS treatment outcomes.

6.

health.ny.gov

health.ny.gov/diseases/aids/ending_the_epidemic/docs/key_resources/housing_and_supportive_services/chain_factsheet3.pdf

Food and Nutrition Services, HIV Medical Care, and Health ...

Food security and good nutrition – access to sufficient and nutritious food - are essential for people living with. HIV/AIDS (PLWH) to maintain an active and ...