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 ]
- before/after CRAG screening implementation (All persons)
- 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