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
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
February 25, 2026
February 1, 2026
3.2 years
June 22, 2021
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (2)
weCare/Secure
ACTIVE COMPARATORThe 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
OTHERThere is no peer navigation within usual care.
Interventions
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
Eligibility Criteria
You may qualify if:
- participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
- be living with HIV
- ≥18 years of age
- provide informed consent
You may not qualify if:
- unable to speak English or Spanish
- have cognitive impairment that would prevent participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
Tanner AE, Palakshappa D, Morse CG, Mann-Jackson L, Alonzo J, Garcia M, Wright E, Dharod A, Isom S, Sucaldito AD, Aviles LR, Rhodes SD. 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: protocol for development and implementation trial of weCare/Secure. Trials. 2022 Dec 12;23(1):998. doi: 10.1186/s13063-022-06924-3.
PMID: 36510319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Rhodes, PhD
Wake Forest Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2021
First Posted
June 29, 2021
Study Start
December 1, 2023
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Last 6 months of Year 5
- 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
Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data