Clincosm LogoSign in Get a demo

HIV Food Insecurities

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04943861
Collaborator
University of North Carolina, Greensboro (Other)
200
Enrollment
1
Location
2
Arms
30.1
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: weCare/Secure
  • Other: Usual Care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • University of North Carolina, Greensboro

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04943861
Other Study ID Numbers:
  • IRB00075503
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Food Insecurity
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Prediabetic State

Study Results

No Results Posted as of Jun 24, 2022