Cardiometabolic Comorbidities, Food Insecurities, HIV, PreDiabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Food Insecurity
Brief summary
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
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
Interventions
BEHAVIORALweCare/Secure
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
OTHERUsual Care
There is no peer navigation within usual care.
Sponsors
Wake Forest University Health Sciences
University of North Carolina, Greensboro
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores | Baseline | 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 |
Countries
United States
Contacts
CONTACTScott D Rhodes, PhD
CONTACTLisa Norfleet
PRINCIPAL_INVESTIGATORScott D Rhodes, PhD
Wake Forest Health Sciences
Outcome results
None listed