Food InsecuritiesNCT04943861
Human Immunodeficiency Virus (HIV) Food Insecurities
A study testing weCare/Secure in people with Food Insecurities and Cardiometabolic Comorbidities, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Insecurities, Cardiometabolic Comorbidities, HIV
- What is being tested?
- weCare/Secure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
- be living with HIV
- ≥18 years of age
- provide informed consent
Who cannot join
- unable to speak English or Spanish
- have cognitive impairment that would prevent participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
Scott D Rhodes, PhD, 336-713-5080, Scott.Rhodes@advocatehealth.org
Lisa L Norfleet, 336-713-5074, Lisa.Lynn.Lewis@advocatehealth.org
About this study
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
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.
Read the 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
- Conditions
- Food Insecurities, Cardiometabolic Comorbidities, HIV, PreDiabetes, Type 2 Diabetes Mellitus (T2DM)
- Being tested
- weCare/Secure, Usual Care
- Keywords
- Food Insecurity
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weCare/SecureBehavioural
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 CareOther
There is no peer navigation within usual care.
| Study group | Role | What they receive |
|---|---|---|
| weCare/Secure | Active comparator | 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 Receives: Behavioral: weCare/Secure |
| Usual Care | Other | There is no peer navigation within usual care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Measured: Baseline
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Measured: Month 12
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Measured: Month 24
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Dec 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecuritiesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Greensboro, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Scott D Rhodes, PhD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943861
- Sponsor's protocol ID
- IRB00075503
- Other IDs
- R01NR020307
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data
Publications
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.
PubMed 36510319
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04943861
- Acronym / sponsor ID
- IRB00075503
- Conditions
- Food Insecurities, Cardiometabolic Comorbidities, HIV, PreDiabetes, Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Food Insecurity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of North Carolina, Greensboro, National Institute of Nursing Research (NINR)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weCare/Secure | Active comparator | Behavioral: weCare/SecureThe 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 | Other | Other: Usual CareThere is no peer navigation within usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
- be living with HIV
- ≥18 years of age
- provide informed consent
Key exclusion criteria (2 listed)
- unable to speak English or Spanish
- have cognitive impairment that would prevent participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weCare/SecureThe 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 | Behavioural | weCare/Secure |
| Usual CareThere is no peer navigation within usual care. | Other | Usual Care |
Primary outcome
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Time frame: Baseline
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Time frame: Month 12
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Time frame: Month 24
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores
Time frame: Month 36
Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Derived from this study: PubMed 36510319Tanner 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.
- Individual participant dataSharing planned: Yes. Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data
Related trials for Food Insecurities
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Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
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Addressing Food Insecurity in Pregnancy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott D Rhodes, PhD principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weCare/Secure in people with Food Insecurities and Cardiometabolic Comorbidities, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott D Rhodes, PhD (336-713-5080, Scott.Rhodes@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.