Inpatient Package to Reduce HIV and AIDS-related Death in Zambia

NCT04033718 | Completed

• 1 other identifier: 300003461
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). In this study the investigators will develop and pilot a new approach to inpatient HIV care that follows international guidelines for management of advanced HIV disease.

Conditions

HIV/AIDS; Transitions of Care; Hospitalization; Tuberculosis; HIV Testing; Cryptococcosis

Outcome Measures

Primary Outcomes (1)

• Coinfection diagnosis

  Positive test for tuberculosis or cryptococcus on admission

  Through hospital discharge, an average of 2 weeks

Study Arms (2)

Inpatient lab bundling plus navigation

EXPERIMENTAL

Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator

Diagnostic Test: Inpatient lab bundling; Behavioral: Inpatient navigation

Inpatient lab bundling alone

EXPERIMENTAL

Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach.

Diagnostic Test: Inpatient lab bundling

Interventions

Inpatient lab bundling DIAGNOSTIC_TEST

The investigators will provide patients a package of diagnostic tests at the time of admission to comprehensively assess for HIV coinfections and treatment failure. These labs are all recommended in advanced HIV guidelines but in this study we will provide all tests as a bundle rather than step-by-step as suggested in guidelines.

Inpatient lab bundling alone; Inpatient lab bundling plus navigation

Inpatient navigation BEHAVIORAL

Participants will be assigned a patient navigator who will support the patient and bedsider (treatment supporter/guardian) during the hospitalization. The navigator will be an HIV counselor who can provide counseling and health education, as well as support specimen transport, obtaining results, booking tests in other departments, linkages to ART clinic, and discharge planning

Inpatient lab bundling plus navigation

Eligibility Criteria

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

You may qualify if:

• + years old
• HIV-positive (by self-report or DCT result in UTH file)
• Resident of Lusaka
• Admitted to the hospital

You may not qualify if:

• Too sick to provide informed consent (based on clinician opinion)
• Likely to be discharged in the next 48 hours (based on clinician opinion)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University Teaching Hospital: collaborator
• University of Maryland: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis; Cryptococcosis

Condition Hierarchy (Ancestors)

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; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses

Study Officials

• Michael J Vinikoor, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 26, 2019
• Study Start: October 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)