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| ID | Type | Description | Link |
|---|---|---|---|
| U01GH000517 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Institute, Uganda | OTHER |
| Makerere University | OTHER |
| Centers for Disease Control and Prevention | FED |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CrAg Screening and Fluconazole | Experimental | Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention in care |
| 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Cryptococcal meningitis-free survival time | 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 | 6-month |
| Survival Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David B Meya, MMed | Makerere University | Principal Investigator |
| Radha Rajasingham, MD | Infectious Disease Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Institute, Makerere University | Kampala | Uganda | ||||
| Kampala Capital Council Authority Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22410867 | Background | Rajasingham R, Meya DB, Boulware DR. Integrating cryptococcal antigen screening and pre-emptive treatment into routine HIV care. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):e85-91. doi: 10.1097/QAI.0b013e31824c837e. | |
| 20597693 | Background | Meya DB, Manabe YC, Castelnuovo B, Cook BA, Elbireer AM, Kambugu A, Kamya MR, Bohjanen PR, Boulware DR. Cost-effectiveness of serum cryptococcal antigen screening to prevent deaths among HIV-infected persons with a CD4+ cell count < or = 100 cells/microL who start HIV therapy in resource-limited settings. Clin Infect Dis. 2010 Aug 15;51(4):448-55. doi: 10.1086/655143. |
| Label | URL |
|---|---|
| Infectious Disease Institute | View source |
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After publication, data to be shared upon request to the Infectious Disease Institute Research Department as per the institutional data sharing policy.
Upon request
Upon request
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| D003453 | Cryptococcosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Survival time among CRAG+ vs. CRAG negative persons with CD4<100 cells/mcL.
| 6-month |
| Uptake of CRAG screening and preemptive treatment | baseline |
| Time from CRAG+ test to receipt of fluconazole therapy | Days from CD4 testing |
| All-cause discontinuation of fluconazole | Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event) | 6-month |
| Percentage of participants with symptomatic cryptococcal meningitis | baseline |
| Risk factors for symptomatic cryptococcal meningitis | baseline |
| Kampala |
| Uganda |
| 30399034 | Result | Meya DB, Kiragga AN, Nalintya E, Morawski BM, Rajasingham R, Park BJ, Mubiru A, Kaplan JE, Manabe YC, Boulware DR. Reflexive Laboratory-Based Cryptococcal Antigen Screening and Preemptive Fluconazole Therapy for Cryptococcal Antigenemia in HIV-Infected Individuals With CD4 <100 Cells/microL: A Stepped-Wedge, Cluster-Randomized Trial. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):182-189. doi: 10.1097/QAI.0000000000001894. |
| D007239 | Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |