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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 36

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

Urinary tract infection

Diarrhoea

Headache

Fall

Abdominal distension

Abdominal pain

Upper respiratory tract infection

Nausea

Haemorrhoids

Breast cancer

Hip fracture

Syncope

Medical device removal

Back pain

Animal bite

Suture related complication

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,286 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research currently enrolling participants?

"Affirmative. As per the data found on clinicaltrials.gov, this medical trial is currently seeking patients to participate in the research; it was initially posted on May 17th 2022 and updated most recently on November 15th 2022. The study requires 200 participants from one site."

Answered by AI

What is the upper limit for individuals participating in this clinical experiment?

"Affirmative. Data available on clinicaltrials.gov reveals that this experiment is currently looking for participants, having been released in May 2022 and last updated in November of the same year. 200 individuals are sought from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Human Immunodeficiency Virus (HIV) Food Insecurities

2023. "Human Immunodeficiency Virus (HIV) Food Insecurities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04943861.

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