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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS, Transitions of Care, Hospitalization, Tuberculosis, HIV Testing, Cryptococcosis

Intervention / Treatment
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* Diagnostic Test: Inpatient lab bundling
* Behavioral: Inpatient navigation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |