Bilingual Intervention for HIV/AIDS-Related Food Insecurity

Overseen By Lisa Lewis

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

Trial Summary

What is the purpose of this trial?

This trial tests a program to help people with HIV who don't have enough food. It aims to improve their blood sugar levels by ensuring they have enough to eat. The goal is to reduce the risk of diabetes and related health issues.

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 data supports the effectiveness of the treatment weCare/Secure for addressing food insecurity in people living with HIV?

Research shows that food insecurity affects up to 50% of people living with HIV in the US, leading to lower medication adherence and increased risk of serious illnesses. The weCare/Secure intervention aims to reduce these risks by using a bilingual peer navigation and mobile health approach, which is being tested for its effectiveness in improving health outcomes for food-insecure individuals with HIV. ^{1 2 3 4 5}

Is the bilingual intervention for HIV/AIDS-related food insecurity safe for humans?

The research does not provide specific safety data for the bilingual intervention (weCare/Secure) for HIV/AIDS-related food insecurity, but it focuses on addressing food insecurity, which is generally considered safe as it involves improving access to adequate and safe foods. ^{2 4 6 7 8}

How is the treatment weCare/Secure different from other treatments for HIV/AIDS-related food insecurity?

The weCare/Secure treatment is unique because it combines bilingual peer navigation with mobile health (mHealth) technology to address food insecurity and related health issues in people living with HIV. This approach is novel as it specifically targets the link between food insecurity and cardiometabolic health, using personalized support and technology to improve health outcomes. ^{1 2 4 7 9}

Research Team

Scott D Rhodes, PhD

Principal Investigator

Wake Forest Health Sciences

Eligibility Criteria

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

I am 18 years old or older.

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

Provide informed consent

Exclusion Criteria

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

I cannot speak English or Spanish.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A valid two-item food security questionnaire for screening HIV-1 infected patients in a clinical setting. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Food Insecurity is Longitudinally Associated with Depressive Symptoms Among Homeless and Marginally-Housed Individuals Living with HIV. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

How food support improves mental health among people living with HIV: A qualitative study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Food insecurity and HIV/AIDS: current knowledge, gaps, and research priorities. [2022]

7. England 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. [2021]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

High prevalence of food insecurity among HIV-infected individuals receiving HAART in a resource-rich setting. [2011]