Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04943861

Conditions

Food Insecurities

Cardiometabolic Comorbidities

HIV

PreDiabetes

Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

weCare/Secure

Usual Care

Study Details

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.

Conditions

Food Insecurities

Cardiometabolic Comorbidities

HIV

PreDiabetes

Type 2 Diabetes Mellitus (T2DM)

Study ID

NCT04943861

Start date

Dec 1, 2023

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Scott D Rhodes, PhD

336-713-5080Scott.Rhodes@advocatehealth.org

Lisa Norfleet

336-713-5074Lisa.Lynn.Lewis@advocatehealth.org

Locations

Wake Forest Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Scott D Rhodes, PhD

336-713-5080Scott.Rhodes@advocatehealth.org

Lisa L Norfleet

336-713-5074Lisa.Lynn.Lewis@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Food Insecurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-04.