What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS include antiretroviral therapy (ART) regimens such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). Known side effects of these treatments can include gastrointestinal issues (nausea, diarrhea), metabolic changes (lipodystrophy, insulin resistance), cardiovascular complications, liver toxicity, and bone density loss. In the context of the study on food insecurity, addressing these side effects is crucial as they can exacerbate cardiometabolic comorbidities, making comprehensive care and dietary interventions essential for improving health outcomes in people with HIV.

What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies (ART) for the treatment of HIV/AIDS, which include classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These treatments aim to reduce viral load, improve immune function, and prevent the progression to AIDS. While the novel bilingual food insecurity intervention focuses on addressing food insecurity to improve health outcomes and reduce cardiometabolic comorbidities among people with HIV, it complements ART by potentially enhancing overall health and adherence to HIV treatment regimens.

What other types of research exist?

Promising alternatives to the Novel Bilingual Food Insecurity Intervention for HIV/AIDS patients include: 1) Community-based nutrition education programs like 'Comprando Rico y Sano' which focus on increasing nutrition knowledge and healthy eating habits. 2) Comprehensive food assistance programs that provide access to nutritious foods and support for SNAP enrollment. 3) Tailored dietary interventions that address specific nutritional needs and comorbidities, such as the DASH diet for managing hypertension. 4) Integrated care models that combine medical nutrition therapy with regular medical care and support services to address both food insecurity and health outcomes.

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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

Must not have

Have cognitive impairment that would prevent participation

Unable to speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 36

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program to help people with HIV who don't have enough food. It aims to improve their blood sugar levels by ensuring they have enough to eat. The goal is to reduce the risk of diabetes and related health issues.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any cognitive issues that would stop me from participating.

Select...

I cannot speak English or Spanish.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Hip fracture

Breast cancer

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

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.