Human Immunodeficiency Virus (HIV) Food Insecurities

Study Overview
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Brief Summary
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The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.

Detailed Description
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The proposed study the team has created a conceptually integrated, mixed methods study that includes Longitudinal data collection to explore the difference in the prevalence and incidence of cardiometabolic comorbidities between food secure and insecure PWH Implementation and evaluation of the weCare/Secure intervention designed to improve insulin sensitivity among food insecure PWH with prediabetes or Type 2 diabetes (T2DM) Semi-structured individual in-depth interviews to understand the effect of the intervention on FI and insulin sensitivity among participants in an randomized controlled trial (RCT) trial Broad dissemination of study findings to inform both research and clinical practice

Official Title
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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

Conditions
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HIV, Cardiometabolic Comorbidities, Food Insecurities, PreDiabetes, Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Behavioral: weCare/Secure
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic be living with HIV ≥18 years of age provide informed consent Exclusion Criteria: unable to speak English or Spanish have cognitive impairment that would prevent participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: weCare/Secure<br>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 | Behavioral: weCare/Secure<br>* 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<br>|
| Other: Usual Care<br>There is no peer navigation within usual care. | Other: Usual Care<br>* There is no peer navigation within usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores | Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance | Baseline | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores | Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance | Month 12 | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores | Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance | Month 24 | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores | Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance | Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity