Table 4.

Association between CrAg positivity and study outcomes among patients.

	CrAg−		CrAg+
Post-baseline clinical outcomes	n/N	% (CI)	n/N	% (CI)	p
Standard of care lab testing*
Cryptococcal meningitis diagnosis
<100 cells/mm3	3/259	1.2 (0.2–3.5)	19/21	90.5 (69.9–98.6)	<0.001
≤200 cells/mm3	3/273	1.1 (0.2–3.3)	25/28	89.3 (72.0–97.1)	<0.001
All-cause hospitalization
<100 cells/mm3	43/259	16.6 (12.5–21.6)	8/21	38.1 (20.7–59.2)	0.033
≤200 cells/mm3	47/273	17.2 (13.2–22.2)	11/28	39.3 (23.5–57.6)	0.010
All-cause mortality
<100 cells/mm3	30/259	11.6 (8.2–16.1)	7/21	33.3 (17.1–54.8)	0.012
≤200 cells/mm3	35/273	12.8 (9.3–17.3)	10/28	35.7 (20.6–54.3)	0.004
Intervention clinic-based testing**
Cryptococcal meningitis diagnosis
<100 cells/mm3	1/84	1.2 (0.0–7.1)	6/6	100.0 (55.7–100.0)	<0.001
≤200 cells/mm3	1/145	0.7 (0.0–4.2)	9/10	90.0 (57.4–100.0)	<0.001
All-cause hospitalization
<100 cells/mm3	13/84	15.5 (9.1–24.8)	3/6	50.0 (18.8–81.2)	0.067
≤200 cells/mm3	16/145	11.0 (6.8–17.3)	4/10	40.0 (16.7–68.8)	0.026
All-cause mortality
<100 cells/mm3	11/84	13.1 (7.3–22.1)	4/6	66.7 (29.6–90.8)	0.007
≤200 cells/mm3	12/145	8.3 (4.7–14.0)	5/10	50.0 (23.7–76.3)	0.002

^*Among patients who were documented receiving a standard of care laboratory-based CrAg test. Includes participants from all three study periods.

^**Intervention period was clinic-based testing period only.

ART: antiretroviral therapy, CI: 95 % confidence interval, CrAg: Cryptococcal antigen.