Clinical Trial: Operational Research for Cryptococcal Antigen Screening

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Operational Research for Cryptococcal Antigen Screening to Improve ART Survival

Brief Summary: This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative

Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Retention in care [ Time Frame: 6-month ]

  1. before/after CRAG screening implementation (All persons)
  2. CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cryptococcal meningitis-free survival time [ Time Frame: 6-month ]
    Cryptococcal meningitis-free survival time in those who are asymptomatic CRAG positive and treated with fluconazole compared to CRAG-negative persons with CD4<100 cells/mcL
  • Survival Time [ Time Frame: 6-month ]
    Survival time among CRAG+ vs. CRAG negative persons with CD4<100 cells/mcL.
  • Uptake of CRAG screening and preemptive treatment [ Time Frame: baseline ]
  • Time from CRAG+ test to receipt of fluconazole therapy [ Time Frame: Days from CD4 testing ]
  • All-cause discontinuation of fluconazole [ Time Frame: 6-month ]
    Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event)
  • Percentage of participants with symptomatic cryptococcal meningitis [ Time Frame: baseline ]
  • Risk factors for symptomatic cryptococcal meningitis [ Time Frame: baseline ]


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: February 10, 2012
Date Started: July 1, 2012
Date Completion:
Last Updated: April 19, 2017
Last Verified: April 2017