NCT04943861

Human Immunodeficiency Virus (HIV) Food Insecurities

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	weCare/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
OTHER	Usual Care	There is no peer navigation within usual care.

Timeline

• Start date: 2023-12-01
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2021-06-29
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States