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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS; Tuberculosis; Cryptococcosis; Hospitalization; HIV Testing; Transitions of Care
• Intervention / Treatment: Diagnostic test: Inpatient lab bundling; Behavioral: Inpatient navigation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J Vinikoor, MD; Phone Number: 8479025400; Email: mjv3@uab.edu
• Study Contact Backup: Name: Jamie White; Phone Number: 2059348145; Email: jamiewhite@uabmc.edu

Study Locations

• Zambia
  • Lusaka, Zambia
    • Recruiting
    • University Teaching Hospital
    • Contact: Lottie Hachaambwa, MBChB; Phone Number: +260 976435603; Email: lhachaambwa@ihv.umaryland.edu
    • Contact: Michael Vinikoor, MD; Phone Number: +260 972921285; Email: mjv3@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inpatient lab bundling plus navigation; 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; 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.; Behavioral: Inpatient navigation; 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
Experimental: Inpatient lab bundling alone; Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach.	Diagnostic test: Inpatient lab bundling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coinfection diagnosis	Positive test for tuberculosis or cryptococcus on admission	Through hospital discharge, an average of 2 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of Maryland; University Teaching Hospital
• Investigators: Principal Investigator: Michael J Vinikoor, MD, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycoses; Mycobacterium Infections; Tuberculosis; Cryptococcosis
• Other Study ID Numbers: 300003461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No