Table 2.
Cryptococcus diagnosis and treatment delivery by study phase and baseline CD4 count.
| Clinician-directed testing | Lab reflex testing | Clinic-based testing | ||
|---|---|---|---|---|
| n/N (%) | n/N (%) | n/N (%) | p | |
| Standard of care diagnosis and treatment | ||||
| Received laboratory-based SoC cryptococcal antigen (CrAg) testing | ||||
| Lab CD4 <100 cells/mm3 | 10/149 (6.7) | 178/178 (100.0) | 92/92 (100.0) | <0.001 |
| Lab CD4 ≤200 cells/mm3 | 11/323 (3.4) | 188/363 (51.8) | 102/222 (45.9) | <0.001 |
| CrAg+ by laboratory-based SoC CrAg testing | ||||
| Lab CD4 <100 cells/mm3 | 3/149 (2.0) | 12/178 (6.7) | 6/92 (6.5) | 0.096 |
| Lab CD4 ≤200 cells/mm3 | 3/323 (0.9) | 16/363 (4.4) | 9/222 (4.1) | 0.011 |
| CrAg+ from laboratory-based SoC CrAg testing, among those who received testing | ||||
| Lab CD4 <100 cells/mm3 | 3/10 (30.0) | 12/178 (6.7) | 6/92 (6.5) | 0.053 |
| Lab CD4 ≤200 cells/mm3 | 3/11 (27.3) | 16/188 (8.5) | 9/102 (8.8) | 0.131 |
| Study intervention Clinic-based CD4 and CrAg testing* | ||||
| Received point-of-care (POC) CD4 test | ||||
| Lab CD4 <100 cells/mm3 | -- | -- | 92/92 (100.0) | -- |
| Lab CD4 ≤200 cells/mm3 | -- | -- | 222/222 (100.0) | -- |
| POC CD4 count ≤200 cells/mm3 | ||||
| Lab CD4 <100 cells/mm3 | -- | -- | 90/92 (97.8) | -- |
| Lab CD4 ≤200 cells/mm3 | -- | -- | 155/222 (69.8)** | -- |
| Received POC serum CrAg lateral flow assay (LFA), if POC CD4 count ≤200 cells/mm3 | ||||
| Lab CD4 <100 cells/mm3 | -- | -- | 90/90 (100.0) | -- |
| Lab CD4 ≤200 cells/mm3 | -- | -- | 155/155 (100.0) | -- |
| CrAg+ by POC serum CrAg LFA | ||||
| Lab CD4 <100 cells/mm3 | -- | -- | 6/90 (6.7) | -- |
| Lab CD4 ≤200 cells/mm3 | -- | -- | 10/155 (6.5) | -- |
ART: antiretroviral therapy, CrAg: Cryptococcal antigen, LFA: lateral flow assay, POC: point-of-care.
*
Intervention period was clinic-based testing period only. Denominators reflect the results from lab-based CD4 testing.
**
Results indicate that 67 people had a POC CD4 >200 cells/mm3, whose had a lab CD4 ≤200 cells/mm3