Food Assistance, Diabetes, and HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-20

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose control is less successful in this population who are also often food insecure. Food assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure PLWH who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

NCT05208671

HIV Insulin Resistance Food Insecurity

RECRUITING NA

Immune Activation as a Cause of Insulin Resistance in Adults Living With HIV-1 on Effective Antiretroviral Therapy

NCT04028882

HIV Infections

TERMINATED

Factors Associated With Advanced HIV and Poor Nutrition Among People Living With HIV

NCT06852430

Advanced HIV Disease Poor Nutriyion Among HIV Patients

NOT_YET_RECRUITING

Intranasal Treatment of HIV-associated Neurocognitive Disorders

NCT03277222

HIV Associated Neurocognitive Disorder (HAND)

TERMINATED PHASE2

Enteropathy and Diabetes in HIV Patients

NCT03713502

Diabetes Environmental Enteropathy HIV

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this investigation is to develop and assess a study protocol to evaluate the impact of food assistance on diabetes-related health outcomes in food insecure people living with HIV (PLWH). Compared to the general population, PLWH have increased risk for type 2 diabetes and worse glycemic control when using similar pharmaceutical treatments. Interventions to improve diet quality could thus have a clinically meaningful impact on diabetes treatment in this population. However, many PLWH are food insecure and rely on food assistance to meet basic nutrition needs. This proposal will determine the feasibility of a protocol to evaluate diabetes-related health outcomes in food insecure PLWH and diabetes who receive high protein, high dietary fiber food boxes from Birmingham AIDS Outreach. The study will consist of retrospective analysis of electronic medical record data and stored specimens, and prospective cross-sectional analysis of food security and diet quality in PLWH who do versus those who do not receive the food boxes.

Specific Aim 1: To determine the feasibility of recruiting, enrolling, and collecting dietary intake data from people living with HIV who are food insecure.

Specific Aim 2: To compare changes over twelve months in glycemic control, food security, and diet quality in B-FED participants compared to non-participating 1917 clinic patients.

This proposal aligns with the UAB Diabetes Research Center's goal to facilitate development of new methods to treat diabetes and its complications. The investigators will determine the effect size for scale-up of larger, longer-term assessment through an NIDDK-R18 grant to evaluate the real-world impact of B-FED on glycemic control and food security.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes HIV/AIDS FOOD SECURITY

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B-FED

Clients of the Birmingham AIDS Outreach Food and Education Delivery (B-FED) program who are also patients at the 1917 Clinic.

Food assistance

Intervention Type OTHER

This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.

non B-FED

Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Food assistance

This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no food assistance

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* CNICS participants aged 18 and over
* Currently prescribed antiretroviral therapy
* Have a diagnosis of diabetes, or documented hemoglobin A1c \>7.0%, or glucose \>125gm/dL

Exclusion Criteria

* Not diagnosed with HIV
* PLWH who are not patients at 1917 Clinic
* Under age 18
* Pregnant women
* Recent cancer diagnosis Current serious illness or trauma Persons with an active secondary infection including tuberculosis or untreated Hepatitis C.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No