Human Immunodeficiency Virus (HIV) Food Insecurities

July 31, 2026 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Other: Usual Care
There is no peer navigation within usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
Month 12
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
Month 24
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
Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

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

Investigators

  • Principal Investigator: Scott D Rhodes, PhD, Wake Forest Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00075503
  • R01NR020307 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data

IPD Sharing Time Frame

Last 6 months of Year 5

IPD Sharing Access Criteria

De-identified data and associated documentation (including codebooks) will be available from the Principal Investigators under a data-sharing agreement with users that provides for a commitment to:

(1) using the data for research purposes; (2) securing the data using appropriate computer technology; and (3) to destroying or returning the data after analyses are completed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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