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Sex Transm Dis. 2014 February ; 41(2): 123128. doi:10.1097/OLQ.0000000000000075.
Bacterial vaginosis and the risk of Trichomonas vaginalis

acquisition among HIV-1 negative women
Jennifer E. Balkus1,2, Barbra A. Richardson1,2,3, Lorna K. Rabe4, Taha E. Taha5, Nyaradzo
Mgodi6, Margaret Phiri Kasaro7, Gita Ramjee8, Irving F. Hoffman9, and Salim S. Abdool
Karim10,11
1Vaccine
and Infectious Disease Division, Fred Hutchinson Cancer Research Center; Seattle,
WA, USA
2Department
of Global Health, University of Washington; Seattle, WA, USA
3Department
of Biostatistics, University of Washington; Seattle, WA, USA
4Magee-Womens
5Department
Research Institute; Pittsburgh, PA, USA
of Epidemiology, Johns Hopkins Bloomberg School of Public Health; Baltimore, MD,
USA
6Department
of Obstetrics and Gynecology College of Health Science, University of Zimbabwe;

Harare, Zimbabwe
7Center
8HIV
for Infectious Disease Research in Zambia; Lusaka, Zambia
Prevention Research Unit, South Africa Medical Research Council; Durban, South Africa
9Division
of Infectious Diseases, University of North Carolina; Chapel Hill, NC, USA
10Centre
for the AIDS Program of Research in South Africa, Doris Duke Medical Research
Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal; Congella, South
Africa
11Department
of Epidemiology, Mailman School of Public Health, Columbia University; New York,
NY, USA
Abstract
BackgroundThe vaginal microbiota may play a role in mediating susceptibility to sexually
transmitted infections, including Trichomonas vaginalis (TV).
MethodsData were analyzed from HIV-1 seronegative women participating in HIV Prevention
Trials Network Protocol 035. At quarterly visits for up to 30 months, participants completed
Correspondence: Jennifer E. Balkus, PhD, MPH, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N., M2-C200, P.O.
Box 19024, Seattle, WA 98109-1024, Phone: +1 206 667 7149, [email protected].
*Please address reprint requests to the corresponding author
This data was presented in part at the International Society for Sexually Transmitted Disease Research, held 14th -17th July 2013 in
Vienna, Austria.
Potential Conflicts of Interest: All authors declare no commercial or other associations that might pose a conflict of interest relevant
to the submitted work.
Balkus et al.
Page 2
structured interviews and specimens were collected for genital tract infection testing. TV was
detected by saline microscopy. BV was characterized by Gram stain using the Nugent score
(BV=7-10; intermediate=4-6; normal=0-3 [reference group]). Cox proportional hazards models
stratified by study site were used to assess the association between Nugent score category at the
prior quarterly visit and TV acquisition.
ResultsIn this secondary analysis, 2,920 participants from Malawi, South Africa, USA,
Zambia and Zimbabwe contributed 16,259 follow-up visits. BV was detected at 5,680 (35%) visits
and TV was detected at 400 (2.5%) visits. Adjusting for age, marital status, hormonal
contraceptive use, unprotected sex in the last week and TV at baseline, intermediate Nugent score
and BV at the prior visit were associated with an increased risk of TV (intermediate score:
adjusted hazard ratio [aHR]=1.73, 95% confidence interval [CI] 1.21-2.19; BV: aHR=2.40, 95%
CI 1.92-3.00). Sensitivity analyses excluding 211 participants with TV at baseline were similar to
those from the full study population (intermediate score: aHR=1.54, 95% CI 1.10-2.14; BV:
aHR=2.23, 95% CI 1.75-2.84)
ConclusionsWomen with a Nugent score >3 were at an increased risk of acquiring TV. If this
relationship is causal, interventions that improve the vaginal microbiota could contribute to
reductions in TV incidence.
Keywords
Bacterial vaginosis; Trichomonas vaginalis; vaginal microbiota; sexually transmitted disease
acquisition; prospective cohort
Introduction
Bacterial vaginosis (BV) is a common vaginal syndrome that affects hundreds of millions of
women globally each year [1, 2]. The presence of BV has been associated with a number of
adverse reproductive health outcomes [2], including an increased risk of sexually
transmitted infections (STIs) [3-8]. Trichomonas vaginalis is one of the most common
curable STIs [9]. It is frequently detected among women with BV [10-12] and is also
associated adverse reproductive health outcomes including preterm birth, low birth weight,
and HIV acquisition [13, 14]. There is mounting evidence that the vaginal microbiota may
play a role in mediating susceptibility to STIs, including TV. It is hypothesized that vaginal
lactobacilli, the predominant bacterial species detected among women with a healthy vaginal
environment, may utilize several mechanisms to protect against genital pathogen
colonization [15]. Lactic acid production contributes to maintaining a lower vaginal pH,
which may inhibit pathogen colonization [16]. In addition, exposure to hydrogen peroxide
(H2O2) producing Lactobacillus species in vitro has been shown to decrease activity of BVassociated bacteria [17] and other genital tract pathogens [18]. Findings from in vitro studies
are supported by data from epidemiologic studies, which showed that the absence or low
levels of Lactobacillus colonization are associated with TV infection [19, 20].
Conversely, several prospective studies have reported an increased risk of TV among
women with an abnormal vaginal microbiota or BV [3, 4, 6-8]. However, published studies
that have assessed the association between the vaginal microbiota and TV acquisition have
Balkus et al.
Page 3
defined normal and abnormal vaginal microbiota in a variety of ways, making it

challenging to compare results across studies. We sought to evaluate the association between
the vaginal microbiota at the prior study visit and incident TV infection among women
enrolled in a biomedical HIV prevention trial using several categorizations of the vaginal
microbiota.
Materials and Methods
This is a secondary analysis of data from women enrolled in HIV Prevention Trials Network
(HPTN) Protocol 035, a phase II/IIB, four-arm, multisite, randomized, controlled trial
comparing BufferGel and 0.5% PRO 2000 gel against two comparator arms (HEC placebo
gel and no gel) for prevention of HIV infection (Clinicaltrials.gov #NCT00074425).
Detailed methods for the trial have been described previously [21]. Briefly, between
February 2005 and October 2008, 3,087 HIV-1 uninfected women from five countries
(Malawi, South Africa, United States of America [USA], Zambia, and Zimbabwe) were
enrolled and followed for a minimum of 12 months and a maximum of 30 months,
depending on the date of enrollment. Eligible women were 18 years of age, HIV-1
seronegative, non-pregnant and sexually active (reported vaginal intercourse at least once in
the past three months). Women were not eligible to participate if they reported a history of
an adverse reaction to latex, history of non-therapeutic injection drug use in the past 12
months, frequent vaginal intercourse (more than two times per day in the prior two weeks),
were within six weeks of the last pregnancy outcome, or had plans to become pregnant
during follow-up. All institutional review boards and relevant regulatory authorities
approved the trial at each site and all participants provided written informed consent.
Participants were randomly assigned in equal proportions to one of the four study arms.
Study gels were dispensed in single-use, pre-filled applicators and were similar in
appearance. Participants in the three gel arms were advised to use condoms and instructed to
insert a single dose of gel intravaginally up to 1 hour prior to each act of vaginal intercourse,
while participants in the no gel arm were advised to use condoms. At each monthly followup visit, a urine pregnancy test was performed. At quarterly visits, data were collected on
self-reported gel use, condom use, sexual behaviors, vaginal washing and contraceptive use.
Speculum-assisted pelvic examinations were performed with collection of specimens for
diagnosis of genital tract infections and blood was collected through venipuncture for HIV-1
testing. All participants received a comprehensive HIV prevention package that included
ongoing HIV risk reduction counseling, free male latex condoms, and diagnosis and
treatment of STIs throughout the trial.
Laboratory procedures
A Gram stain of vaginal fluid was evaluated at a central laboratory for diagnosis of BV
using the Nugent score [22]. A vaginal saline wet mount was examined microscopically for
the presence of motile trichomonads for diagnosis of TV. Urine specimens were tested for
Chlamydia trachomatis and Neisseria gonorrhoeae annually and at study exit using BD
ProbeTec ET (Becton Dickinson; Franklin Lakes, New Jersey, USA). HIV-1 infection status
was determined using a standardized algorithm. The Determine HIV 1/2 (Abbott Diagnostic
Balkus et al.
Page 4
Division; Hoofddorp, Netherlands) test was used with either the OraQuick (Orasure
Technologies; Bethlehem, Pennsylvania, USA), or Uni-Gold Recombigen HIV test
(Trinity Biotech; Wicklow, Ireland). Western blot (Genetics systems HIV-1 Western Blot
kit, BioRad Laboratories; Hercules, CA, USA) was performed on samples with any positive
HIV-1 result. HSV-2 testing was performed at enrollment and study exit using the
HerpeSelect-2 EIA (Focus Technologies; Cypress, California, USA).
Statistical analysis
The objective of this analysis was to assess the association between the vaginal microbiome
at the quarterly visit prior to TV testing and first incident TV infection. The vaginal
microbiome was characterized using the Nugent score, where a score of 7-10 indicated BV,
4-6 was considered intermediate and 0-3 was considered normal (reference group). In our
primary analysis, we separately compared incident TV infections among women with a
Nugent score of 7-10 and 4-6 versus 0-3. Secondary analyses included comparisons of
incident TV among women with a Nugent score >3 versus 0-3 and a Nugent score >6 versus
0-6, as these comparisons have been utilized by others [3, 4, 6-8]. Participants were
excluded from the analysis if they did not return for a follow-up visit after enrollment, did
not receive TV testing during follow-up or if they were found to be HIV-1 infected at
baseline. If Nugent score results were not available at the quarterly visit prior to TV testing,
the TV result visit was excluded from the analysis. Log-binomial regression with
generalized estimating equations using an independent correlation structure and robust
standard errors was used to assess demographic, behavioral and clinical factors associated
with BV. Cox proportional hazards models stratified by study site were used to assess the
association between the Nugent score at the prior quarterly visit and TV acquisition. Age,
marital status, unprotected sex in the past week and baseline TV status were included in the
multivariable model based on a priori assumptions. Additional factors were considered for
inclusion in the model if they were associated with BV by Nugent score and incident TV
infection (p<0.10). Participants were censored at their first incident TV infection or if they
became pregnant, HIV-1 infected or tested positive for another STI (C. trachomatis or N.
gonorrhoeae). Since participants received treatment for STIs diagnosed at enrollment, we
included participants diagnosed with TV at baseline in the primary analysis. However,
among women with TV at baseline, subsequent infections may represent TV persistence or
re-infection; therefore, we conducted a sensitivity analysis excluding participants who tested
positive for TV at enrollment. All statistical tests were assessed using a 2-sided of 0.05.
Analyses were conducted using Stata version 12.0 (StataCorp, Inc., College Station, TX).
Results
Of 3,087 HIV-1-uninfected participants enrolled in HPTN 035, 71 (2%) participants did not
return for follow-up, did not undergo TV testing during follow-up or did not have BV results
in the interval prior to all TV testing during follow-up. In addition, 96 (3%) participants
were censored for other reasons prior to having a TV test with BV results during follow-up
and were excluded (81 were censored due to pregnancy, 11 were HIV-infected, and 4 were
diagnosed with another STI), leaving 2,920 (95%) participants who contributed 16,259
follow-up visits for analysis. Compared to participants included in the analysis, participants
Balkus et al.
Page 5
who were excluded were slightly younger (median age [interquartile range (IQR)]: 23 years
(21-27) versus 25 years (22-30); p<0.001) and less likely to be married or living with a
partner (58% versus 70%; p=0.007). Sexual behaviors reported at baseline, BV and STIs
were similar between participants who were included versus those excluded from the
analysis (data not shown).
Demographic, behavioral, and clinical characteristics at enrollment are presented in

aggregate and by TV acquisition status during follow-up in Table 1. The median number of
follow-up visits per participant was 4 (IQR: 3-6). BV by Nugent score was detected at 5,680
(35%) of 16,259 visits and an intermediate score was present at 2,622 (16%) visits. Being
married or living with a partner was associated with a decreased likelihood of BV during
follow-up (odds ratio [OR] = 0.90; 95% confidence interval [CI] 0.83, 0.98). In addition,
compared to participants not using hormonal contraception, oral hormonal contraception and
injectable hormonal contraception were both associated with modest decreases in the
likelihood of BV during follow-up (oral contraceptive use: OR=0.90; 95% CI 0.80, 0.99;
injectable use: OR=0.77; 95% CI 0.70, 0.84). Conversely, TV at baseline was associated
with an increased likelihood of BV (OR=1.19; 95% CI 1.04, 1.36). Self-reported sexual
behaviors (number of sex partners in the past 3 months, vaginal sex in the past week,
unprotected sex in the past week), vaginal washing practices, and study arm were not
associated with BV during follow-up (data not shown).
Overall, TV was detected at 400/16,259 (2.5%) visits; TV was detected at 1.5% (118/7,957)
of visits with a normal Nugent score at the prior visit compared to 2.6% (67/2,622) among
visits with an intermediate score at the prior visit and 3.8% (215/5,680) among women with
BV at the prior visit. In univariate analyses, higher Nugent score category at the prior visit
was associated with an increased risk TV infection (Table 2). An intermediate score was
associated with a 1.73-fold increased likelihood of TV (95% CI 1.28, 2.33), while BV was
associated with a 2.53-fold increased likelihood (95% CI 2.02, 3.17). This linear trend in the
hazard ratios was statistically significant (p<0.001). After adjusting for age, marital status,
hormonal contraceptive use, unprotected sex in the last week and TV at baseline, an
intermediate score and BV at the prior visit were independently associated with an increased
likelihood of TV (Table 2). Secondary analyses using alternative categorizations of the
Nugent score showed similar results (Nugent score >3 versus 0-3: aHR = 2.15, 95% CI 1.74,
2.67; Nugent score >6 versus 0-6: aHR = 2.06, 95% CI 1.69, 2.51).
Baseline TV was also associated with an increased risk of TV in our multivariable model
(aHR=2.65; 95% CI 2.03, 3.48). Although participants diagnosed with TV at baseline
received treatment according to the study protocol, subsequent infections may represent TV
persistence due to treatment failure or re-infection if the partner was not treated (especially
among participants who tested positive for TV at their first follow-up visit). Therefore, we
conducted a sensitivity analysis excluding 211 participants who had baseline TV infection
(39 [18%] of which were also infected with TV at their next follow-up visit). Among 2,709
participants without TV infection at baseline, the likelihood of TV infection among women
with abnormal vaginal microbiota was similar to results observed for the full study
population for both intermediate Nugent score (aHR = 1.54; 95% CI 1.10, 2.14) and BV
(aHR= 2.23; 95% CI 1.75, 2.84).
Balkus et al.
Page 6
Discussion
Women with BV or an intermediate Nugent score were at an increased risk of acquiring TV

compared to women with a normal vaginal microbiota. Results were similar when we
assessed different categorizations of the Nugent score (>3 versus 0-3 and >6 versus 0-6).
The findings from our analyses extend those reported by others and add to the evidence that
suggests that an abnormal vaginal microbiota increases susceptibility to TV infection [3, 4,
6-8].
Although a number of studies have reported an increased risk of TV acquisition among

women with BV, the precise nature of the relationship between specific vaginal bacterial
species and communities and TV susceptibility is not well understood. Over the past decade,
molecular techniques targeting bacterial 16S ribosomal RNA gene (rDNA) sequences have
been used to characterize the vaginal microbiota [23], and hold great promise for providing
insight into the relationships between vaginal health and STI acquisition, including TV.
Improving our understanding of the relationship between the vaginal microbiota and TV
susceptibility could lead to effective, targeted interventions that eradicate high-risk bacteria
and promote vaginal colonization with bacterial species and communities that are associated
with lower STI risk.
We also observed that women with TV infection at baseline had an increased likelihood of
TV acquisition during follow-up, despite receiving treatment for TV at enrollment into the
trial. The majority of women with TV at baseline tested negative for TV at their next followup visit. In addition, greater than 95% of women reported only 1 sexual partner during
follow-up, suggesting that these women were re-infected with TV by their partners. Testing
and treatment services were available to partners of women participating in the study;
however, data on partner treatment was not systematically collected. Partner treatment
services are not routinely offered in sub-Saharan Africa, where syndromic treatment is
commonly used for STI treatment and microbiologic testing is not frequently performed
[24]. As STI diagnostic capacity improves in resource-limited settings, additional
information on the acceptability and uptake of partner treatment services in research studies
and other clinical settings where pathogen specific STI testing and treatment occur as part of
standard of care will be helpful for informing the scale-up of these services.
Compared to women not using hormonal contraception, we observed a decreased likelihood

of TV among women using oral or injectable hormonal contraception. There is mixed
evidence regarding the effect of hormonal contraception on TV acquisition. Several studies
have reported a reduced risk of TV among women using oral or injectable hormonal
contraception, while others have observed no association [3, 7, 25, 26]. There are a number
of methodological challenges that complicate analyses assessing the effect of hormonal
contraception on STI acquisition, including choice of comparison group, method switching,
and inadequate control of potential time-varying confounding factors such as condom use
[27]. Differences in study design and analytic approach may contribute to the heterogeneity
of published results. In the present analysis, the relationship between hormonal
contraception and TV acquisition was assessed as a potential confounder and was not
assessed as the primary objective of the study; therefore our findings should be interpreted
Balkus et al.
Page 7
in that context. Additional studies that appropriately address methodological challenges are
needed to improve our understanding of the relationship between hormonal contraception
and TV acquisition.
The present analysis includes several limitations that should be considered when interpreting
the results. The primary limitation of this analysis is that only saline microscopy was used to
detect TV infection. Although it is the most commonly used method for TV diagnosis in
clinical settings, saline microscopy has considerably lower sensitivity compared with culture
and nucleic acid amplification testing (NAAT) [28]. Use of a less sensitive diagnostic
method for TV detection may have resulted in failure to detect TV infection in some
women, which would contribute to an attenuation of the results. Furthermore, TV is more
likely to be detected among women with a higher vaginal pH [13]. If organism burden
differs by BV status, the low sensitivity of saline microscopy for TV detection may have
resulted in greater TV detection among women with BV compared to those without. Thus,
the relationship between BV and TV could be related to parasite density and its inherent
impact on detection rather than differences in infection rates. Additional prospective studies
using more sensitive diagnostics methods (NAAT) will help to further clarify the
relationship between BV and TV acquisition. The interval between BV assessment and TV
testing is also a limitation of this study. Evidence from prospective studies has shown that
the vaginal microbiota fluctuates over time [29, 30]. Shorter intervals between assessment of
BV and TV status, such as monthly testing, would reduce potential misclassification in the
characterization of the vaginal microbiota prior to TV acquisition. In addition, our study
population included women at risk for HIV infection participating in a clinical trial who may
differ from women in the general population. Lastly, BV and STI acquisition are both
associated with sexual activity [31]. Although the observed associations were strong and we
attempted to control for confounding due to sexual behavior in our multivariable analyses, it
is possible that a proportion of the observed association between BV and TV could be
explained by insufficient control of important behavioral confounders.
In summary, women with an abnormal vaginal microbiota were at an increased risk of

acquiring TV compared to women with a normal vaginal microbiota. We observed a doseresponse relationship, whereby the risk of TV acquisition increased with higher Nugent
score category. If the relationship between the vaginal microbiota and TV acquisition is
causal, interventions that decrease the incidence of BV and promote a normal vaginal
microbiota could potentially contribute to reductions in TV incidence. However, current BV
treatments fail to produce sustained changes in the vaginal microbiota [32-34]. Alternative
regimens that improve cure rates and produce sustained changes in the vaginal microbiota
are needed. Such interventions that successfully cure and control BV could be evaluated in
clinical trials as part of a vaginal health approach to reducing susceptibility to TV infection.
Acknowledgments
We sincerely thank the women who participated in this study. We gratefully acknowledge the HPTN 035 study
team and study sites for their work on data and sample collection and the Statistical Center for their work on data
management.
Funding: HIV Prevention Trials Network (HPTN) Protocol 035 was funded by the US National Institutes of Health
(NIH). The trial was designed and implemented by the HPTN and the Microbicide Trials Network (MTN). The
Balkus et al.
Page 8
HPTN (U01AI4674) has been funded by the National Institute of Allergy and Infectious Diseases (NIAID), the
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National
Institute of Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH). The MTN (UM1AI068633)
has been funded by NIAID, NICHD, and NIMH. The Statistical Center was supported by NIAID (UM1AI068615).
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factors associated with recurrence. J Infect Dis. 2006; 193:14781486. [PubMed: 16652274]
Balkus et al.
Page 10
Table 1
Participant characteristics at enrollment into HPTN 035*
All participants
N=2,920
Participants who acquired TV

infection during follow-up
N=400
Participants who did not acquire TV

N=2,520
1,303 (45)
174 (44)
1,129 (45)
25-29 years
840 (29)
94 (23)
746 (30)
30-34 years
532 (18)
68 (17)
464 (18)
35-39 years
112 (4)
32 (8)
80 (3)
>40 years
133 (5)
32 (8)
101 (4)
Married or co-habiting
2,041 (70)
247 (62)
1,794 (71)
Some secondary school
1,832 (63)
207 (52)
1,625 (64)
404 (14)
42 (11)
362 (14)
Malawi Lilongwe
574 (20)
115 (29)
459 (18)
South Africa Durban
666 (23)
48 (12)
618 (25)
South Africa Hlabisa
317 (11)
96 (24)
221 (9)
USA Philadelphia
193 (7)
46 (12)
147 (6)
Zambia Lusaka
303 (10)
23 (6)
280 (11)
Zimbabwe Chitungwiza
248 (8)
16 (4)
232 (9)
Zimbabwe Harare
215 (7)
14 (3)
201 (8)
No Gel
728 (25)
97 (25)
629 (25)
Placebo
728 (25)
99 (25)
631 (25)
PRO2000
733 (25)
117 (27)
616 (24)
BufferGel
731 (25)
87 (22)
644 (26)
Vaginal sex in the past 7 days
2,504 (86)
312 (78)
2,192 (87)
Condom use at last sex (%)
1,988 (68)
254 (64)
1,734 (69)
1,800 (62)
275 (69)
1,525 (61)
Water
776 (27)
68 (17)
708 (28)
Soap & water
326 (11)
49 (12)
277 (11)
Demographic characteristics
Age
<25 years
Site
Malawi Blantyre
Study arm
Behaviors
Vaginal washing1
Nothing
Vinegar & water

Paper, cotton, cloth, wool
73 (3)
19 (5)
54 (2)
294 (10)
39 (10)
255 (10)
567 (19)
53 (13)
514 (20)
1,419 (49)
176 (44)
1,243 (49)
37 (1)
5 (1)
32 (1)
1,082 (37)
197 (49)
885 (35)
Hormonal contraception
Oral contraceptives
Injectables
Implants
Laboratory characteristics
Nugent score 7-10 (BV)
Balkus et al.
Page 11
All participants
N=2,920
Participants who acquired TV

N=400
Participants who did not acquire TV

N=2,520
Nugent score 4-6 (intermediate)
506 (17)
77 (19)
429 (17)
Trichomonas vaginalis
211 (7)
71 (18)
140 (6)
Chlamydia trachomatis2
100 (3)
17 (4)
83 (3)
Neisseria gonorrhoeae2
20 (1)
1(<1)
19 (1)
1,265 (43)
217 (54)
1,048 (42)
HSV-2 seropositive
*
Data presented as N (%)
At enrollment, participants were asked about vaginal washing practices in the past month. Total >100% as participants could choose more than
one option.
2
Chylamidia and gonorrhea results missing for 1 participant


67 (17)
215 (54)
4-6 (intermediate)
7-10 (BV)
1,104 (7)
68 (17)
32 (8)
32 (8)
30-34 years
35-39 years
71 (18)
TV at baseline
188 (47)
Injectable contraceptive use

4 (1)
63 (16)
Implant
145 (36)
None/non-hormonal methods
Oral contraceptive use
Hormonal contraception
307 (77)
104 (26)
Unprotected sex in the past week1
11 (3)
Vaginal sex in the past week
385 (96)
1 (reference)
>1
none
Sex partners in the past 3 months

4 (1)
207 (52)
At least some secondary school
Behaviors at each visit
247 (62)
Married or co-habiting
>40 years
710 (4)
94 (23)
886 (6)
224 (1.41)
8,384 (53)
3,285 (21)
3,966 (25)
3,951 (25)
12,979 (82)
329 (2)
15,336 (97)
194 (1)
9,864 (62)
11,359 (72)
3,284 (21)
4,595 (29)
174 (44)
<25 years
6,166 (39)
5,465 (35)
2,555 (16)
7,839 (49)
Visits without TV
N=15, 859
25-29 years
Age
Enrollment characteristics
118 (30)
0-3 (reference)
Nugent score at prior study visit
Visits with TV
N=400
3.40
0.39
0.52
0.44
1.00
1.07
0.72
1.48
1.00
1.01
0.64
0.64
1.47
1.97
0.83
0.77
1.00
2.53
1.73
1.00
HR
(2.62, 4.42)
(0.15, 1.03)
(0.42, 0.64)
(0.33, 0.59)
---
(0.86, 1.34)
(0.57, 0.91)
(0.82, 2.68)
---
(0.38, 2.69)
(0.53, 0.78)
(0.52, 0.78)
(0.99, 2.18)
(1.34, 2.90)
(0.62, 1.10)
(0.60, 0.99)
---
(2.02, 3.17)
(1.28, 2.33)
---
(95% CI)
Unadjusted
<0.001
0.06
<0.001
<0.001
---
0.53
0.006
0.20
---
0.98
<0.001
<0.001
0.06
0.001
0.19
0.04
---
<0.001
<0.001
---
p-value
2.65
0.57
0.60
0.64
1.00
1.02
0.88
0.74
0.99
0.79
0.82
1.00
2.40
1.63
1.00
HR

Table 2
(2.03, 3.48)
(0.20, 1.60)
(0.47, 0.78)
(0.47, 0.89)
---
(0.81, 1.28)
(0.64, 1.22)
(0.45, 1.21)
(0.65, 1.50)
(0.58, 1.05)
(0.64, 1.05)
---
(1.92, 3.00)
(1.21, 2.19)
---
(95% CI)
Adjusted*
<0.001
0.29
<0.001
0.007
---
0.86
0.45
0.23
0.96
0.10
0.12
---
<0.001
0.001
---
p-value
Demographic and behavioral factors associated with incident TV
Balkus et al.
Page 12
Stratified by site and adjusted for age (category), marital status, hormonal contraceptive use (time-varying characteristic), unprotected sex (time-varying characteristic) and TV at baseline.
Versus sex with a condom or no sex
Balkus et al.
Page 13

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Published in final edited form as:

Bacterial vaginosis and the risk of Trichomonas vaginalis

of Global Health, University of Washington; Seattle, WA, USA

of Biostatistics, University of Washington; Seattle, WA, USA

NIH-PA Author Manuscript

Research Institute; Pittsburgh, PA, USA

of Epidemiology, Johns Hopkins Bloomberg School of Public Health; Baltimore, MD,

of Obstetrics and Gynecology College of Health Science, University of Zimbabwe;

for Infectious Disease Research in Zambia; Lusaka, Zambia

of Infectious Diseases, University of North Carolina; Chapel Hill, NC, USA

of Epidemiology, Mailman School of Public Health, Columbia University; New York,

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NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

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defined normal and abnormal vaginal microbiota in a variety of ways, making it

Materials and Methods

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NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

Demographic, behavioral, and clinical characteristics at enrollment are presented in

NIH-PA Author Manuscript

Women with BV or an intermediate Nugent score were at an increased risk of acquiring TV

NIH-PA Author Manuscript

Although a number of studies have reported an increased risk of TV acquisition among

NIH-PA Author Manuscript

Compared to women not using hormonal contraception, we observed a decreased likelihood

NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

In summary, women with an abnormal vaginal microbiota were at an increased risk of

NIH-PA Author Manuscript

NIH-PA Author Manuscript

NIH-PA Author Manuscript

Participant characteristics at enrollment into HPTN 035*

NIH-PA Author Manuscript

Participants who acquired TV

Participants who did not acquire TV

Some secondary school

South Africa Durban

South Africa Hlabisa

Vaginal sex in the past 7 days

Condom use at last sex (%)

Soap & water

NIH-PA Author Manuscript

NIH-PA Author Manuscript

Vinegar & water

NIH-PA Author Manuscript

Participants who acquired TV

Participants who did not acquire TV

Nugent score 4-6 (intermediate)

Data presented as N (%)

Chylamidia and gonorrhea results missing for 1 participant