Food Assistance, Diabetes, and HIV

NCT04045184 | Withdrawn

• 2 other identifiers: IRB-300001424P30DK079626
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; HIV/AIDS; FOOD SECURITY

Outcome Measures

Primary Outcomes (3)

• To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure.

  We will track the ability to recruit and enroll eligible participants in the study.

  1 year

• Change in diabetes-related health outcomes as measured by hemoglobin A1c.

  Six months after program enrollment, B-FED participants will have improved glycemic control (lower hemoglobin A1c). Value will be measured using stored blood samples.

  1 year

• Compare food security among groups using the Food Security Questionnaire.

  B-FED participants will report a higher prevalence of food security compared to clinic patients who do not participate in the program. This will be assessed at 1 time point using the validated 2-item Food Security Questionnaire to classify participants as food secure, low food security, or very low food security.

  1 year

Study Arms (2)

B-FED

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

Other: Food assistance

non B-FED

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

Interventions

Food assistance OTHER

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

Also known as: no food assistance

B-FED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients at the UAB 1917 Clinic who are diagnosed with HIV and type 2 diabetes.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: NONE RETAINED

Stored serum will be analyzed for markers of glycemic control: glucose, insulin, glycosylated hemoglobin, and fructosamine.

MeSH Terms

Conditions

Diabetes Mellitus; Acquired Immunodeficiency Syndrome

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: August 5, 2019
• Study Start: October 20, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)