Table 3.
Intervention group | Standard-of-Care groups | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Total (N=908) |
Clinic-based testing (N=222) | Clinician-directed testing (N=323) | Lab reflex testing (N=363) | |||||||
Post-baseline clinical outcomes | n | % (CI) | n | % (CI) | n | % (CI) | p* | n | % (CI) | p* |
Primary outcomes | ||||||||||
Cryptococcal meningitis diagnosis | 30 | 3.3 (2.3–4.7) | 10 | 4.5 (2.4–8.2) | 5 | 1.5 (0.6–3.7) | 0.059 | 15 | 4.1 (2.5–6.8) | 0.836 |
All-cause hospitalization | 98 | 10.8 (8.9–13.0) | 21 | 9.5 (9.5–14.1) | 28 | 8.7 (6.0–12.3) | 0.762 | 49 | 13.5 (10.3–17.4) | 0.151 |
All-cause mortality | 85 | 9.4 (7.6–11.4) | 18 | 8.1 (5.1–12.5) | 31 | 9.6 (6.8–13.3) | 0.648 | 36 | 9.9 (7.2–13.5) | 0.557 |
Secondary outcomes | ||||||||||
Hospitalization due to known cryptococcal infection | 11 | 1.2 (0.7–2.2) | 4 | 1.8 (0.5–4.7) | 4 | 1.2 (0.4–3.3) | 0.721 | 3 | 0.8 (0.2–2.5) | 0.436 |
Mortality due to known cryptococcal infection | 9 | 1.0 (0.5–1.9) | 4 | 1.8 (0.5–4.7) | 1 | 0.3 (0.0–1.9) | 0.164 | 4 | 1.1 (0.3–2.9) | 0.486 |
Initiation of antiretroviral therapy | 850 | 93.6 (91.8–95.0) | 215 | 96.8 (93.5–98.6) | 295 | 91.3 (87.7–94.0) | 0.012 | 340 | 93.7 (90.6–95.8) | 0.121 |
Received fluconazole preventative therapy** | 46 | 5.1 (3.8–6.7) | 16 | 7.2 (4.4–11.5) | 8 | 2.5 (1.2–4.9) | 0.010 | 22 | 6.1 (4.0–9.1) | 0.607 |
Received intravenous amphotericin-B | 8 | 0.9 (0.9–3.1) | 3 | 1.4 (0.3–4.1) | 4 | 1.2 (0.4–3.3) | 1.000 | 1 | 0.3 (0.0–1.7) | 0.156 |
Lost to follow-up | 113 | 12.4 (10.5–14.8) | 16 | 7.2 (4.4–11.5) | 56 | 17.3 (13.6–21.9) | 0.001 | 41 | 11.3 (8.4–15.0) | 0.116 |
CI: 95% confidence interval.
p-value represents a Fisher’s exact test of the comparison between each standard of care group with the Intervention group.
Oral fluconazole was indicated for people with serum cryptococcal antigenemia, but without cryptococcal meningitis.