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

Not Applicable

Completed

• Conditions: Tuberculosis; HIV Testing; HIV/AIDS; Transitions of Care; Cryptococcosis; Hospitalization
• Interventions: Diagnostic Test: Inpatient lab bundling; Behavioral: Inpatient navigation

• Registration Number: NCT04033718
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2021-10-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient lab bundling alone	Inpatient lab bundling	Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach.
Inpatient lab bundling plus navigation	Inpatient 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
Inpatient lab bundling plus navigation	Inpatient lab bundling	Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator

Primary Outcome Measures

Name	Time	Method
Coinfection diagnosis	Through hospital discharge, an average of 2 weeks	Positive test for tuberculosis or cryptococcus on admission

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia