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Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

NCT05510973 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

  • Opportunistic Infections, HIV-Related
  • Cryptococcal Infections
  • AIDS With Tuberculosis
  • AIDS-related Kaposi Sarcoma
  • AIDS and Infections

Interventions

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)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Thulani Maphosa, PhD · Elizabeth Glaser Pediatric AIDS Foundation

  • Appolinaire Tiam, MBChB, MMed, PhD · Elizabeth Glaser Pediatric AIDS Foundation

  • Rose Nyirenda, MPH, PhD · Ministry of Health, Malawi

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-03-31
Completion
2023-06-30

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510973 on ClinicalTrials.gov