Human Immunodeficiency Virus (HIV) Food Insecurities
Primary Purpose
Food Insecurities, Cardiometabolic Comorbidities, HIV
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weCare/Secure
Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Food Insecurities focused on measuring Food Insecurity
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
Sites / Locations
- Wake Forest Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
weCare/Secure
Usual Care
Arm Description
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
There is no peer navigation within usual care.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04943861
First Posted
June 22, 2021
Last Updated
September 26, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
University of North Carolina, Greensboro
1. Study Identification
Unique Protocol Identification Number
NCT04943861
Brief Title
Human Immunodeficiency Virus (HIV) Food Insecurities
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
University of North Carolina, Greensboro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurities, Cardiometabolic Comorbidities, HIV, PreDiabetes, Type 2 Diabetes Mellitus (T2DM)
Keywords
Food Insecurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
weCare/Secure
Arm Type
Active Comparator
Arm Description
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
Arm Title
Usual Care
Arm Type
Other
Arm Description
There is no peer navigation within usual care.
Intervention Type
Behavioral
Intervention Name(s)
weCare/Secure
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
There is no peer navigation within usual care.
Primary Outcome Measure Information:
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Description
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
Time Frame
Baseline
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Description
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
Time Frame
Month 12
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Description
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
Time Frame
Month 24
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Description
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
Time Frame
Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott D Rhodes, PhD
Phone
336-713-5080
Email
srhodes@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Lewis
Phone
336-713-5074
Email
Lisa.Lynn.Lewis@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Rhodes, PhD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott D Rhodes, PhD
Phone
336-713-5080
Email
srhodes@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Lisa L Lewis
Phone
336-713-5074
Email
Lisa.Lynn.Lewis@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Human Immunodeficiency Virus (HIV) Food Insecurities
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