Human Immunodeficiency Virus (HIV) Food Insecurities

Wake Forest University (WFU)

Status: Enrolling

Conditions: Food Insecurities; Type 2 Diabetes Mellitus (T2DM); HIV; Cardiometabolic Comorbidities; PreDiabetes

Treatments: Other: Usual Care; Behavioral: weCare/Secure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04943861

IRB00075503

R01NR020307 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

weCare/Secure

Active Comparator group

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

Treatment:

Behavioral: weCare/Secure

Usual Care

Other group

Description:

There is no peer navigation within usual care.

Treatment:

Other: Usual Care