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

Tuberculosis Clinical Trial

— IPADZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033718
• Other study ID #: 300003461
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Michael J Vinikoor, MD
• Phone: 8479025400
• Email: mjv3[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cryptococcosis
• HIV Testing
• HIV/AIDS
• Hospitalization
• Transitions of Care
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University of Maryland, University Teaching Hospital

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coinfection diagnosis	Positive test for tuberculosis or cryptococcus on admission	Through hospital discharge, an average of 2 weeks