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

Primary Purpose

HIV/AIDS, Transitions of Care, Hospitalization

Status
Recruiting
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Inpatient lab bundling
Inpatient navigation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inpatient lab bundling plus navigation

Inpatient lab bundling alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Coinfection diagnosis
Positive test for tuberculosis or cryptococcus on admission

Secondary Outcome Measures

Full Information

First Posted
July 23, 2019
Last Updated
April 28, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
University Teaching Hospital, University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT04033718
Brief Title
Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
Acronym
IPADZ
Official Title
Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University Teaching Hospital, University of Maryland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Transitions of Care, Hospitalization, Tuberculosis, HIV Testing, Cryptococcosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inpatient lab bundling plus navigation
Arm Type
Experimental
Arm Description
Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator
Arm Title
Inpatient lab bundling alone
Arm Type
Experimental
Arm Description
Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach.
Intervention Type
Diagnostic Test
Intervention Name(s)
Inpatient lab bundling
Intervention Description
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
Behavioral
Intervention Name(s)
Inpatient navigation
Intervention Description
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
Primary Outcome Measure Information:
Title
Coinfection diagnosis
Description
Positive test for tuberculosis or cryptococcus on admission
Time Frame
Through hospital discharge, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Vinikoor, MD
Phone
8479025400
Email
mjv3@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie White
Phone
2059348145
Email
jamiewhite@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Vinikoor, MD
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lottie Hachaambwa, MBChB
Phone
+260 976435603
Email
lhachaambwa@ihv.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Michael Vinikoor, MD
Phone
+260 972921285
Email
mjv3@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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