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. Author manuscript; available in PMC: 2022 Aug 15.
Published in final edited form as: J Acquir Immune Defic Syndr. 2021 Aug 15;87(5):1205–1213. doi: 10.1097/QAI.0000000000002717

Table 3.

Clinical outcomes by study phase.

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.