What this study is
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.
What's being tested
- weCare/Secure
Intervention · 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
Intervention · OTHER
There is no peer navigation within usual care.
Study details
- 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
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Food Insecurities · Cardiometabolic Comorbidities · HIV · PreDiabetes · Type 2 Diabetes Mellitus (T2DM)
- Enrolling
- 200 people
- Starts
- 2023-12-01
- Est. completion
- 2027-02-28
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
- Be living with HIV
- ≥18 years of age
- Provide informed consent
You can't join if
- Unable to speak English or Spanish
- Have cognitive impairment that would prevent participation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWake Forest Health Sciences
Winston-Salem, North Carolina, United States
- Scott D Rhodes, PhD · Contact336-713-5080Scott.Rhodes@advocatehealth.org
- Lisa L Norfleet · Contact336-713-5074Lisa.Lynn.Lewis@advocatehealth.org
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00075503
Principal investigator
Scott D Rhodes, PhD
Wake Forest Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.