Human Immunodeficiency Virus (HIV) Food Insecurities

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04943861
Status
Recruiting
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Conditions

  • Cardiometabolic Comorbidities
  • Food Insecurities
  • HIV
  • PreDiabetes
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • weCare/Secure — BEHAVIORAL
    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
  • Usual Care — OTHER
    There is no peer navigation within usual care.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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
  • Other: Usual Care
    There is no peer navigation within usual care.

Primary Outcome Measure

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Health SciencesWinston-SalemNorth Carolina27157
Scott D Rhodes, PhD
[email protected]
336-713-5080
Lisa L Norfleet
[email protected]
336-713-5074

Find similar trials in Winston-Salem, NC

By condition
HIV
By specialty
Infectious disease
By research site
Wake Forest Health Sciences· Winston-Salem, NC

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