Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa

Table 1 Baseline characteristics of men, comparison by enrolment status and study arm

Variable	Enrolled			Not enrolled (C) (n = 134)	P (A + B vs C)
Variable	Immediate (A) (n = 75)	Deferred (B) (n = 75)	P (A vs B)	Not enrolled (C) (n = 134)	P (A + B vs C)
Median age (IQR)	25 (23–29)	26 (23–29)	0.390	30 (26–36)	<0.001
Born in SA	50 (66.7)	49 (65.3)	0.864	93 (69.4)	0.541
Single	64 (85.3)	64 (85.3)	1.000	102 (76.1)	0.002
Any employment^a	40 (53.3)	40 (53.3)	1.000	78 (58.2)	0.409
Completed secondary education	72 (96.0)	63 (84.0)	0.018	115 (85.8)	0.482
Johannesburg resident >1 year	69 (92.0)	67 (89.3)	0.575	120 (89.6)	0.530
Median lifetime partners (IQR)	7 (5–13)	9 (5–20)	0.238	10 (6–20)	0.007
Median age coital debut (IQR)	16 (15–18)	16 (15–19)	0.861	17 (15–19)	0.132
Used condom at each sex act^b	47 (62.7)	58 (77.3)	0.063	45 (52.3)	0.052
High-risk female partners^c	33 (44.0)	31 (41.3)	0.741	62 (51.7)	0.767
Vaccination history^d	48 (64.0)	55 (73.3)	0.309	106 (79.1)	0.126
Perceived HIV risk	10 (13.3)	6 (8.0)	0.551	32 (23.9)	0.010
Previous sex with male partner	2 (2.7)	1 (1.3)	0.500	4 (3.0)	0.710
Circumcised	22 (29.3)	27 (36.0)	0.384	48 (35.8)	0.545
Syphilis^e	2 (2.7)	2 (2.7)	0.690	16 (11.9)	<0.001
N. gonorrhoea ^e	2 (2.7)	1 (1.3)	0.500	2 (1.5)	0.553
T. vaginalis ^e	1 (1.3)	0 (0.0)	-	6 (4.5)	0.055
C. trachomatis	10 (6.7)	12 (8.0)	0.907	12 (9.0)	0.139
HSV-2	17 (22.7)	19 (25.3)	0.512	54 (41.2)	<0.001
HIV-1	0 (0.0)	0 (0.0)	-	16 (12.0)	-
Hepatitis B	0 (0.0)	0 (0.0)	-	87 (65)	-
HIV and hepatitis co-infection	0 (0.0)	0 (0.0)	-	10 (7)	-

^aPart-time, self- or full-employment; ^bIn past 3 months, with most recent partner; ^cSex partner has other partners and never tested for HIV to man’s knowledge; ^dAny vaccination, including experimental or immunisations. ^eFisher’s exact test

ISSN: 1471-2458