Recruiting NCT04943861

Human Immunodeficiency Virus (HIV) Food Insecurities

No phase Interventional Food Insecurities Cardiometabolic Comorbidities HIV PreDiabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: weCare/Secure, Usual Care.
Who it may be relevant to: Registry conditions: Food Insecurities, Cardiometabolic Comorbidities, HIV, PreDiabetes. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

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.

Primary outcome measures

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores [Time frame: Baseline]
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores [Time frame: Month 12]
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores [Time frame: Month 24]
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores [Time frame: Month 36]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Prevention

Study locations

United States · 1 center

Wake Forest Health Sciences — Winston-Salem

Publications

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. 20 PMID 36510319

Identifiers

NCT: NCT04943861 · IRB00075503 · R01NR020307

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗