Study Results
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-12-01
2026-02-28
Brief Summary
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Detailed Description
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* 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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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
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.
Usual Care
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
Usual Care
There is no peer navigation within usual care.
Eligibility Criteria
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Inclusion Criteria
* be living with HIV
* ≥18 years of age
* provide informed consent
Exclusion Criteria
* have cognitive impairment that would prevent participation
18 Years
ALL
No
Sponsors
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University of North Carolina, Greensboro
OTHER
National Institute of Nursing Research (NINR)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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.
Other Identifiers
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IRB00075503
Identifier Type: -
Identifier Source: org_study_id