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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05510973
Other study ID # EG0264
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date June 30, 2023

Study information

Verified date February 2023
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.


Description:

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Study Design


Intervention

Other:
Enhanced package for AHD care
The enhanced package of AHD care includes CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], offered through a hub-and-spoke facility system, with continuous quality improvement (QI)

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Sponsors (2)

Lead Sponsor Collaborator
Elizabeth Glaser Pediatric AIDS Foundation Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of AHD patients alive and retained in care Number of AHD patients alive and retained in care divided by the number of AHD patients initiated on antiretroviral therapy (ART) after diagnosis of AHD 6 and 12 months after initiation on ART after AHD diagnosis
Primary Proportion of AHD patients in care and treatment virally suppressed Number of AHD patients in care and treatment virally suppressed (<50 cells/ml) divided by the number of AHD patients in care and treatment 6 and 12 months after initiation of ART after AHD diagnosis
Secondary Cost analysis of implementing the hub and spoke enhanced AHD package of care Estimation of total costs, costs per patients with the intervention, and cost drivers 12 months after intervention implementation
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