Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04943861

Human Immunodeficiency Virus (HIV) Food Insecurities

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Food Insecurities Cardiometabolic Comorbidities Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders HIV Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State Type 2 Diabetes Mellitus (T2DM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weCare/Secure

Behavioral

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

Usual Care

Other

There is no peer navigation within usual care.

Primary outcomes

  1. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores

    Time frame: 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

  2. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores

    Time frame: Month 12

    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

  3. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores

    Time frame: Month 24

    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

  4. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Norfleet

CONTACT

[email protected]

336-713-5074

Scott D Rhodes, PhD

CONTACT

[email protected]

336-713-5080

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of North Carolina, Greensboro

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.