Clinical trial NCT04943861: Human Immunodeficiency Virus (HIV) Food Insecurities
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurities
Cardiometabolic Comorbidities
HIV
PreDiabetes
Type 2 Diabetes Mellitus (T2DM)
Keywords: Food Insecurity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Greensboro
name: National Institute of Nursing Research (NINR)
First posted: 2021-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
timeFrame: Baseline
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
timeFrame: Month 12
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
timeFrame: Month 24
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
timeFrame: Month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Scott D Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References: