Characteristic	Median (range) or n (%)a
Age (years)	33 (22–46)
Years since HIV diagnosis	5 (1–15)
CD4 count (cells/µL)	366 (209–930)
HIV-1 plasma viral load (log copies/mL)	4.6 (2.9–5.8)
Knew they had genital herpes before enrollment Knew they had genital herpes based on (n=17) Symptoms Told by a provider Partner has herpes Other	17 (25%) 13 (77%) 8 (47%) 2 (12%) 4 (24%)
Time since they knew they had genital herpes (n=17)	3 years (4 months–10 years)

Ever had symptoms consistent with genital herpes	40 (60%)
Time since last symptom (n=40)	3 months (1–4 months)
Symptom (n=40) Genital itching or tingling Genital sore Genital pain Genital burning More than one symptom	38 (95%) 34 (85%) 23 (58%) 23 (58%) 35 (88%)
Site of symptom (n=40) Vagina Buttocks Anal/perianal Upper thighs More than one site	36 (90%) 7 (18%) 3 (8%) 3 (8%) 8 (20%)

Table1 Baseline characteristics of 67 HIV-1/HSV-2 co-infected women, Chiang Rai, Thailand

Abbreviations: HSV-2, herpes simplex virus type 2
aPercentages are out of 67 unless otherwise indicated in the ‘Characteristic’ column

HSV-2 shedding (N=561)

HIV-1 shedding (N=525)

Characteristic

n (%)

PRb (95% CI)

n (%)

PRb (95% CI)

Overall

149

(26.6)

370

(70.5)

Baseline characteristics

Age group (years)
22-30
30-39
40-46

19
94
36

(18.8)
(28.1)
(28.8)

1.0
1.5
1.5

(ref)
(0.7–3.3)
(0.6–3.6)

66
220
84

(68.0)
(69.6)
(75.0)

1.0
1.0
1.1

(ref)
(0.8–1.3)
(0.8–1.5)

Baseline HIV-1 plasma viral load
(log10 copies/mL)
= 4.0
4.0-5.0
> 5.0

16
88
45

(11.0)
(31.7)
(32.9)

1.0
2.5
2.3

(ref)
(1.2–5.0)c
(1.0–5.2)c

42
206
122

(30.7)
(78.9)
(96.1)

1.0
2.3
2.9

(ref)
(1.6–3.5)c
(1.9–4.2)c

Knew they had genital herpes before enrollment
No
Yes

113
36

(27.2)
(24.7)

1.0
0.9

(ref)
(0.5–1.6)

273
97

(69.8)
(72.4)

1.0
1.0

(ref)
(0.8–1.3)

Ever had symptoms consistent with genital herpes
No
Yes

62
87

(27.1)
(26.2)

1.0
1.0

(ref)
(0.6–1.7)

161
209

(73.5)
(68.3)

1.0
1.0

(ref)
(0.8–1.2)

Placebo month characteristics

CD4 count (cells/µL)d
209-350
351-500
501-930

71
65
13

(25.0)
(38.7)
(11.9)

1.0
1.5
0.5

(ref)
(0.9–2.6)
(0.3–1.0)

216
107
47

(81.8)
(67.7)
(45.6)

1.0
0.8
0.6

(ref)
(0.7–1.0)c
(0.4–0.9)c

Phase of menstrual cyclee
Follicular
Periovulatory
Luteal

29
39
51

(27.6)
(22.9)
(24.6)

1.0
0.8
0.8

(ref)
(0.5–1.2)
(0.5–1.3)

81
118
144

(77.1)
(69.4)
(69.6)

1.0
0.9
0.9

(ref)
(0.8–1.0)
(0.8–1.0)

HIV sheddinga
No
Yes

25
114

(16.1)
(30.8)

1.0
1.4

(ref)
(1.0–1.9)

Symptoms and/or soresf
No symptoms or sores
Symptoms only
Sores only
Symptoms and sores

114
10
15
10

(22.9)
(43.5)
(65.2)
(62.5)

1.0
2.0
2.7
2.8

(ref)
(1.2–3.3)c
(1.6–4.4)c
(1.7–4.5)c

320
21
17
12

(69.0)
(91.3)
(77.3)
(75.0)

1.0
1.3
1.1
0.8

(ref)
(0.8–2.3)
(0.6–2.1)
(0.3–1.8)

Table2 Characteristics associated with HSV-2 and HIV-1 sheddinga on genital swabs self-collected from 67 women during the placebo month, Chiang Rai, Thailand.

Abbreviations: CI, confidence interval; HSV-2, herpes simplex virus type 2; PR, prevalence ratio; ref, referent
a Defined as binary outcomes, with non-detectable viral shedding considered no shedding and a non-quantifiable or quantifiable viral shedding considered shedding. b Prevalence Ratios (PR) are adjusted for multiple comparisons for each woman.
c P < .05
d CD4 count was measured twice during the study period; the value closest to the placebo month was used.
e Categorized as follicular (4-19 days before ovulation), periovulatory (3 days before to 3 days after ovulation), or luteal (4-14 days after ovulation) based on the estimated cycle day; women without menses or on hormonal contraceptives were excluded (n=38), n=43 missing menstrual cycle phase.
f Defined as presence of prodromal symptoms and/or sores on diary cards in the two days prior to and day of swabs collection (three-day window before swabs collection). Symptoms were defined as burning, itching, tingling, or pain at any site/event (vagina/vulva, anus/perianal area, when urinating, thighs/buttocks, or other); sore was defined as sore at any site (vagina/vulva, anus, buttocks, thighs, or other). Symptoms and/or sores categories are mutually exclusive.

Variable	HSV-2 sheddingc (N=561) aPR (95% CI)		HIV sheddingc (N=525) aPR (95% CI)
Symptoms and/or sores
No symptoms, no sores	1.0	(ref)	1.0	(ref)
Symptoms only	2.0	(1.2-3.3)d	1.4	(0.6-3.2)
Sores only	2.7	(1.6-4.4)d	1.1	(0.4-2.8)
Sores and symptoms	2.8	(1.7-4.5)d	0.7	(0.3-2.2)
Baseline HIV-1 plasma viral load (log10 copies/mL)	1.5	(1.1-2.1)d	7.5	(4.2-13.1)d

Table3 Adjusteda prevalence ratios between symptoms and/or soresb and HSV-2 and HIV-1 shedding on self-collected genital swabs, Chiang Rai, Thailand

Abbreviations: aPR, adjusted prevalence ratio; CI, confidence interval; ref, referent
a Adjusted for HIV plasma viral load
b Defined as presence of prodromal symptoms and/or sores on diary cards in the two days prior to and day of swabs collection (three-day window before swabs collection). Symptoms were defined as burning, itching, tingling, or pain at any site/event (vagina/vulva, anus/perianal area, when urinating, thighs/buttocks, or other); sore was defined as sore at any site (vagina/vulva, anus, buttocks, thighs, or other). Symptoms and/or sores categories are mutually exclusive.
c Defined as binary outcome, with non-detectable viral shedding considered no shedding and a non-quantifiable or quantifiable viral shedding considered shedding.
d P < .05