Human Immunodeficiency Virus (HIV) Food Insecurities

Not Applicable

Recruiting

• Conditions: Food Insecurities; PreDiabetes; Type 2 Diabetes Mellitus (T2DM); HIV; Cardiometabolic Comorbidities
• Interventions: Other: Usual Care; Behavioral: weCare/Secure

• Registration Number: NCT04943861
• Lead Sponsor: Wake Forest University Health Sciences

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

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-29
• Study Start: 2023-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	There is no peer navigation within usual care.
weCare/Secure	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

Primary Outcome Measures

Name	Time	Method
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores	Month 36	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

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States