An observational study in Cryptococcal Meningitis, sponsored by University of Zimbabwe. Completed at 1 site in Zimbabwe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by University of Zimbabwe · Observational
The study will determine if the initiation of a 'screen and treat' program for cryptococcal disease among HIV positive individuals decreases morbidity and mortality among individuals with CD4 count \< 100 cells/mm3. The study will screen individuals who are asymptomatic for CM and are either ART naïve or ART experienced with CD4 count \< 100 cells/mm3.
The introduction of an cheap, easy to use point of care diagnostic test the lateral flow assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings. The investigators will determine the efficacy of the lateral flow assay in identifying latent and asymptomatic cryptococcal disease. The investigators will determine the efficacy of the test in detecting disease in readily available body fluids such as urine and whole blood obtained via finger-stick method. The investigators will also determine the cost effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe.
The investigators also wish to understand why some individuals with low CD4 counts reactivate cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while others with similar levels of immunocompromised do not.
The study will recruit Asymptomatic participants with severe immunosuppression at risk of cryptococcal disease. The individuals will have a CD4 count \<100cells/mm3 and can be ART naive or ART experienced with no symptoms of active Cryptococcal disease.
They will be recruited from outpatient HIV/ART clinics.
Exclusion Criteria:
There are no arms to the study. All participants will undergo screening. Preemptive treatment will only be provided to those who are CrAg positive.
Other: Pre-emptive screening and treatment for cryptococcal disease
Preemptive screening for cryptococcal disease among individuals with CD4 counts below 100 cells/mm3 with anti fungal therapy for those what are Cryptococcus antigen positive. These participants will be followed longitudinally for 12 months to determine clinical outcome, with their outcome compared with similar patients who are cryptococcal antigen negative, who will also be followed longitudinally for 12 months.
12- month survival in CrAg-positive persons vs. CrAg-negative persons screened
Time frame: 12 months
Seroprevalence of asymptomatic cryptococcal antigenemia among individuals with CD4≤100 cells/mm3 in an urban population in Zimbabwe
Time frame: 24 months
Sensitivity, specificity, positive and negative predictive values of point-of-care urine CrAg LFAs
Time frame: 24 months
Sensitivity, specificity, positive and negative predictive values of point-of-care whole blood CrAg LFAs
Time frame: 24 months
Proportion of individuals with CD4≤100 cells/mm3 and a positive CrAg assay who have disseminated cryptococcal infection with either blood infection or CSF involvement
Time frame: 24 months
12-month survival among individuals with CD4≤100 cells/mm3 prior to implementation of CrAg screening program using historical controls
Retrospective analysis
Time frame: 24 months
Cost of implementation of CrAg screening among individuals with CD4≤100 cells/mm3
Time frame: 24 months
Cryptococcus-associated mortality among individuals with CD4≤100 cells/mm3,
Time frame: 24 months
Incidence of cryptococcal and non-cryptococcal IRIS
Time frame: 24 months
Barriers to uptake of diagnostic LP by individuals with asymptomatic cryptococcal antigenemia.
Questionnaire will be administered to participants who are serum cryptococcal antigen positive who decline to undergo LP.
Time frame: 24 months
Inflammatory cytokines and functional impairments in antigen specific T cells that are associated with the development of cryptococcal antigenemia and meningitis.
Analysis will be done by ELISA and Luminex assays, cell culture and flow cytometry techniques, data collected will be entered into a database and analyzed by patient characteristics.
Time frame: 24 months
Impact of ART mediated immune reconstitution on the inflammatory cytokine profile and the cryptococcal antigen specific CD4+ T cell response in those with serum and CSF cryptococcal antigenemia compared with those without.
Analysis will be done by ELISA and Luminex assays, cell culture and flow cytometry techniques, data collected will be entered into a database and analyzed by patient characteristics. Data will be longitudinal including baseline characteristics and subsequent follow-up data at 6 months and 12 months.
Time frame: 24 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Zimbabwe