Human Immunodeficiency Virus (HIV) Food Insecurities

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943861
• Other study ID #: IRB00075503
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Scott D Rhodes, PhD
• Phone: 336-713-5080
• Email: srhodes[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• HIV
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes Mellitus (T2DM)

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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