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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Addressing food insecurities in people living with HIV

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

Run by Wake Forest University Health Sciences · NCT04943861 · Data updated 2026-11-12

This study is testing a new program to see if it can help people living with HIV who struggle with food insecurity improve their health and manage diabetes better.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations1 site (Winston-Salem, North Carolina)
StatusRecruiting
StartedDecember 1, 2023
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2027
Registry record updatedAugust 4, 2026
Trial IDNCT04943861 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who are patients at the Wake Forest Infectious Diseases Specialty Clinic and are living with HIV.

Probably not a fit

Patients who do not speak English or Spanish or have cognitive impairments that prevent participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to understand how food insecurities contribute to cardiometabolic comorbidities in people living with HIV and to evaluate a bilingual intervention designed to alleviate these issues. The research involves longitudinal data collection to compare health outcomes between food secure and insecure participants, alongside a randomized controlled trial of the weCare/Secure intervention aimed at improving insulin sensitivity in those with prediabetes or Type 2 diabetes. Additionally, semi-structured interviews will be conducted to gain insights into the intervention's impact on food insecurity and health. The findings will be disseminated to enhance both research and clinical practices.

Why it matters

Potential benefit: If successful, this study could significantly improve health outcomes for food insecure individuals living with HIV by reducing the incidence of cardiometabolic comorbidities.

How similar studies have gone: Other studies have shown success in addressing food insecurity and its health impacts, but this specific approach targeting food insecure individuals with HIV is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Wake Forest Health Sciences
    Winston-Salem, North Carolina, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.