Human Immunodeficiency Virus (HIV) Food Insecurities

NCT ID: NCT04943861

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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

Conditions

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

Keywords

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Food Insecurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

weCare/Secure

Intervention Type 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

There is no peer navigation within usual care.

Group Type OTHER

Usual Care

Intervention Type OTHER

There is no peer navigation within usual care.

Interventions

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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

Intervention Type BEHAVIORAL

Usual Care

There is no peer navigation within usual care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Greensboro

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott D Rhodes, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Scott D Rhodes, PhD

Role: CONTACT

Phone: 336-713-5080

Email: [email protected]

Lisa Norfleet

Role: CONTACT

Phone: 336-713-5074

Email: [email protected]

Facility Contacts

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Scott D Rhodes, PhD

Role: primary

Lisa L Norfleet

Role: backup

References

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Tanner AE, Palakshappa D, Morse CG, Mann-Jackson L, Alonzo J, Garcia M, Wright E, Dharod A, Isom S, Sucaldito AD, Aviles LR, Rhodes SD. 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: protocol for development and implementation trial of weCare/Secure. Trials. 2022 Dec 12;23(1):998. doi: 10.1186/s13063-022-06924-3.

Reference Type DERIVED
PMID: 36510319 (View on PubMed)

Other Identifiers

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R01NR020307

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00075503

Identifier Type: -

Identifier Source: org_study_id