RecruitingPhase 3NCT05085171

An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease

A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease


Sponsor

Makerere University

Enrollment

2,400 participants

Start Date

May 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age \>18 years
  • CD4\<200 cells/µL
  • Ability and willingness to give informed consent for the enhanced package of care arm.

Exclusion Criteria2

  • Known virologic suppression (viral load \<1000 copies/mL) within prior 3 months
  • Cannot or unlikely to attend regular clinic visits

Interventions

OTHEREnhanced care package

The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections


Locations(1)

kisugu health center IV

Kampala, Uganda

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NCT05085171