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

NCT ID: NCT04033718

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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HIV/AIDS Transitions of Care Hospitalization Tuberculosis HIV Testing Cryptococcosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Inpatient lab bundling

Intervention Type 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 navigation

Intervention Type 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 alone

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

Group Type EXPERIMENTAL

Inpatient lab bundling

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Teaching Hospital

UNKNOWN

Sponsor Role collaborator

University of Maryland

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Vinikoor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Vinikoor, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

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University Teaching Hospital

Lusaka, , Zambia

Site Status

Countries

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Zambia

Other Identifiers

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300003461

Identifier Type: -

Identifier Source: org_study_id

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