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Bilingual Intervention for HIV/AIDS-Related Food Insecurity

N/A
Recruiting
Led By Scott D Rhodes, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 36
Awards & highlights

Study Summary

This trial will test a novel bilingual FI intervention designed to reduce cardiometabolic comorbidities among food insecure PWH.

Who is the study for?
This trial is for adults over 18 with HIV who are patients at the Wake Forest Infectious Diseases Specialty Clinic. They must understand English or Spanish and be able to give informed consent. People with cognitive impairments that prevent participation cannot join.Check my eligibility
What is being tested?
The study aims to see if a new bilingual intervention called weCare/Secure can reduce cardiometabolic issues linked to food insecurity in people with HIV, compared to usual care provided by the clinic.See study design
What are the potential side effects?
Since this trial focuses on a social support intervention rather than medication, traditional side effects are not applicable. However, participants may experience changes in stress levels or emotional well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565
51%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usual CareExperimental Treatment1 Intervention
There is no peer navigation within usual care.
Group II: weCare/SecureActive Control1 Intervention
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which uses a combination of drugs to target different stages of the HIV life cycle. These include reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors. These drugs work together to reduce the viral load, improve immune function, and decrease the risk of HIV-related complications and transmission. Effective management of HIV through ART is particularly important for patients facing food insecurity, as it can help mitigate additional health burdens and improve overall health outcomes.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,006,953 Total Patients Enrolled
University of North Carolina, GreensboroOTHER
31 Previous Clinical Trials
16,441 Total Patients Enrolled
Scott D Rhodes, PhDPrincipal InvestigatorWake Forest Health Sciences
4 Previous Clinical Trials
702 Total Patients Enrolled

Media Library

HIV/AIDS Research Study Groups: weCare/Secure, Usual Care
~133 spots leftby Nov 2025
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