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. 2016 Feb 3;30(4):635–644. doi: 10.1097/QAD.0000000000000956

Table 2.

Incidence of malaria by trial arm, follow-up time, trial site, adherence to trial drug and ITN use.

	Trial arm	Episodes	Person-years	Rate/100 person-years (95% CI)^a	Rate ratio^a	P value (CTX vs. placebo)	P value (for interaction)^b
Clinical malaria
	CTX	103	2540	4.1 (3.3–5.0)	1	<0.001
	Placebo	350	2515	14.1 (12.5–15.0)	3.5 (2.5–4.4)
Severe malaria^c^,^d
	CTX	2	2543	0.08 (0.02–0.31)	1	0.004
	Placebo	13	2524	0.52 (0.30–0.89)	6.55 (1.48–29.01)
Stratified analyses
Stratum variable
Follow-up time
1st year	CTX	51	1065	4.8 (3.6–6.3)	1	<0.001	0.097
	Placebo	183	1062	17.3 (14.8–20.2)	3.6 (2.6–5.0)
2nd year	CTX	29	939	3.1 (2.1–4.5)	1	<0.001
	Placebo	120	924	13.1 (10.8–15.8)	4.2 (2.8–6.4)
After 2nd year	CTX	23	536	4.3 (2.8–6.5)	1	0.004
	Placebo	47	528	9.0 (6.7–12.1)	2.1 (1.3–3.5)
Site
Entebbe	CTX	19	1215	1.6 (1.0–2.5)	1	<0.001	<0.001
	Placebo	127	1209	10.6 (8.8–12.8)	6.8 (4.1–11.1)
Masaka	CTX	84	1325	6.3 (5.1–7.9)	1	<0.001
	Placebo	223	1306	17.2 (14.8–20.0)	2.7 (2.1–3.6)
Trial drug adherence
Good adherence at
≥80% of visits^e^,^f	CTX	57	1724	3.3 (2.5–4.4)	1	0.01	0.25
<80% of visits^e^,^f	CTX	46	816	5.6 (4.1–7.6)	1.7 (1.1–2.6)
≥80% of visits^e^,^g	Placebo	205	1617	12.8 (12.0–14.9)	1	0.05
<80% of visits^e^,^g	Placebo	145	897	16.4 (13.6–19.8)	1.3 (1.0–1.6)
ITN use
Reported always using ITN at
≥90% of visits	CTX	86	2124	4.1 (3.3–5.1)	1	P = 0.98	0.39
<90% off visits	CTX	17	416	4.1 (2.5–6.7)	1.0 (0.6–1.7)
≥90% of visits	Placebo	267	2038	13.3 (11.6–15.2)	1	P = 0.06
<90% off visits	Placebo	83	476	17.5 (13.6–22.5)	1.3 (1.0–1.8)

CTX, cotrimoxazole; ITN, insecticide-treated bed net.

^arates and rate ratios adjusted for clustering of multiple episodes within participant using random effects Poisson regression.

^bP value for interaction between stratum variable with treatment arm.

^cP. falciparum malaria with clinical or laboratory features of severity.

^dRates and rate ratios from Poisson regression without adjustment for clustering since no participant had more than one episode.

^e‘Good’ adherence defined as 80–105% of expected tablets taken, based on pill counts.

^fRate ratio and P value for comparison in CTX arm.

^gRate ratio and P value for comparison in placebo arm.