Detecting Trichomonas vaginalis in

High-Risk Women: A Tricky Situation

Mariea Snell, DNP, FNP-C, Mary Lee Barron, PhD, FAANP, and
Cathy Koetting, DNP, NP-C

ABSTRACT
Trichomonas vaginalis (TV) is an easily treated but difficult-to-diagnose infection with
the standard wet prep (WP) method. A point-of-care (POC) test has been developed
with a sensitivity of 85%-90% and specificity of 100%. This new test is more costly
than the traditional WP. Incorporating this POC test with the WP using a step
approach may increase detection of TV while minimizing cost. In this pilot study of
50 subjects, 12 (24%) tested positive for TV. With the WP method, 7 (14%) tested
positive. Of the 43 negative patients, an additional 5 (11.6%) tested positive using the
POC test, indicating a significant result.

Keywords: STI testing, Trichomonas vaginalis, vaginitis

Ó 2016 Elsevier, Inc. All rights reserved.

INTRODUCTION A newer point-of-care (POC) test has become

T
richomonas vaginalis (TV) has long been
seen as an easily treated infection, yet it
is deceptively difficult to diagnose. This
infection affects approximately 7.4 million people
in the United States and 276.4 million people
worldwide each year.1,2 For many years, TV was
considered a harmless parasitic infection, presumably
due to the fact that most patients presented
asymptomatically or with mild symptoms. In recent
years, research has linked this infection with higher
rates of HIV-1 acquisition and transmission, preterm
births, cervical cancer, pelvic inflammatory disease,
and infertility.3-5 Risk factors for TV include poverty,
lower educational level, concurrent chlamydia
infection, African American ethnicity, multiple sex
partners, and increased age.5
Currently, the method used most often for diag-
nosis is a wet prep (WP) test.2 This method of testing
allows for in-office detection, which improves
treatment rates. However, there are limitations to
the effectiveness of this testing method. Research
has shown this approach to have a sensitivity of
38%-66% and specificity of 100%.6-8 The observers’
experience, time from collection to assessment, and
the adequacy of the specimen account for much of
the variability in sensitivity.9
www.npjournal.org
available exclusively from OSOM, and can be per-
formed in the office. The test has a sensitivity of
85%-90% and specificity of 100%, and can be read
in 10 minutes.6,8 Although this form of testing is
more costly (approximately $11 per test) than the
traditional WP, providing immediate results and
therefore improved patient outcomes may make this
worth the added expense.7 Pattullo et al.8 studied 345
low-risk women with and without clinical symptoms
of vaginal infection and argued for a step approach
to TV testing. By adding a POC TV test to 307 of
the 345 women (participants who had negative WP
testing), an additional 27 cases were identified, giving
an overall prevalence of 18.8%.8 The investigators
reported that a WP test followed by POC testing
was the most sensitive approach. This suggests that
this same step approach to testing in a high-risk
population could yield an even higher rate of
detection. The aim of this study was to evaluate
this step approach and test its efficacy in women
who are at high risk for TV infection.
LITERATURE REVIEW
A strong argument exists for improvement in
detection of TV infections. Evidence for this comes
from earlier public health studies of female sex
The Journal for Nurse Practitioners - JNP 271
workers who acquired HIV-1 and had a history
of previous TV infection.4,5 Other researchers
examining the use of polymerase chain reaction
analysis for detecting TV in a general population
also noted a correlation of HIV-1 acquisition with
a prior history of TV infection.10 Noting the strong
correlation of TV infection with subsequent HIV-1
infection in parts of the world where both infections
are common, the increased ability to diagnose TV
could also help reduce the spread of HIV-1. The
United States Centers for Disease Control and
Prevention (CDC) recommends testing all women
with vaginal discharge for TV, yet there are no national
guidelines for screening asymptomatic women.11
Thus, it is unknown how many asymptomatic women
are not being treated for TV as a result of a lack of
guidelines. Meites et al.10 studied the prevalence of
TV in symptomatic and asymptomatic women in
15 sexually transmitted disease (STD) clinics in the US.
“Symptomatic” was operationally defined as complaint
of any relative subjective symptom and/or objective
sign, and “asymptomatic” if no relevant sign or
symptom was reported. Although the clinics varied
in their rates of screening asymptomatic women
(1.6%-15%), 3,909 of the total 19,197 asymptomatic
women were screened and 254 (6.5%) were found to
be infected (2013). The rates of detecting infection
were highly dependent on the screening practices of a
particular clinic. Overall, the clinics showed a lack of
consistent practice. However, the researchers did find
that those clinics that performed more screening tests
detected a higher rate of TV.10
Meites et al.10 also found the highest prevalence of
TV-infected women among those who self-defined
racially as black non-Hispanic and in the 50þ-year
age range. Notably, in all races in the study (black
non-Hispanic, white non-Hispanic, and Hispanic),
the prevalence of TV infection increased with age.
Among black non-Hispanic women in New York
City who use drugs, researchers found that 38%
screened positive for TV infection.12 Of those who
initially screened as negative, 31% subsequently
became infected, as detected in repeated screening.
Due to the possibility that TV infection has become
pervasive in the black non-Hispanic population, the
researchers advocate for a control strategy to combat
the disease prevalence.1 This strategy includes
272 The Journal for Nurse Practitioners - JNP
screening in nonclinical settings and rapid POC
testing to more effectively treat an easily curable
infection.13,14
Nathan et al.7 provided support for the use of a
rapid detection POC test: the OSOM Trichomonas
Rapid Test (Sekisui Diagnostics, Lexington, MA).
The study consisted of 246 sexually active women,
age  18 years, who presented with symptoms of
vaginitis. Subjects were screened for TV using 5
methods: the WP; the POC test; culture; in-house
real-time polymerase chain reaction; and the Aptima
test. The prevalence of TV was 9.75% (24 of 246
women). Only 7 women were positive by all
5 methods. Another 11 women were negative by WP
but positive by the other 4 methods. The WP method
yielded 9 (3.66%) cases. When 1 of the other 4
methods was added to the WP, a further 14 cases were
identified. Compared with a testing regime consisting
of WP and culture, the OSOM test had a sensitivity
of 83.3% and a specificity of 98.8%, as compared with
71.4% and 100% for WP. Culture results took
48-72 hours to detect TV. The OSOM test provided
results in 10 minutes. Most importantly, the rapid
test detected an additional 27% (8 of 30) of TV in-
fections that were WP negative but culture positive.
Similar to previous studies, the researchers also found
that prevalence of TV did not decrease with age as
with other sexually transmitted infections (STIs) such
as Chlamydia trachomatis and Neisseria gonorrhea.7
Researchers concluded that the OSOM test is
projected to cost significantly less than culture and
nucleic acid amplification methods and the same as
WP when looking at costs based on a clinician’s time.
Most importantly, use of a rapid POC test such as the
OSOM could increase detection in a difficult-to-reach
population, have a significant impact on a clinician’s
time, and impact the consequences of this STD.7
Huppert et al.15 tested the sensitivity and
specificity of 4 types of tests for TV: WP; culture;
rapid antigen testing (using OSOM TV); and
transcription-mediated amplication (TMA) testing
using Gen-Probe. They found that both TMA and
rapid antigen testing were highly sensitive and spe-
cific; both were superior in identifying TV compared
with WP in 330 adolescent women (14-21 years
of age) who presented to a teen health center or
emergency room over a 2-year period. Of those
Volume 12, Issue 4, April 2016
participants with positive TV infections, TV was
detected by WP in 31 patients and by at least 1 TV
test in 61 patients. Those with TV infections were
likely to have concurrent C trachomatis or gonorrhea.
Overall, the rapid antigen test performed as well as
culture in identifying TV and was equivalent to the
TMA test in specificity.15
Huppert et al.15 also highlighted the need for
improved detection of TV in adolescent women
because about 50% of the cases were missed by WP.
The rapid antigen test is an inexpensive, objective
POC test, so an advantage is the immediate treatment
and counseling of STI for these patients. In this
sample population, the OSOM POC test used for
identifying infection in adolescent women helped
to increase the treatment rate. Adolescents can be
a particularly difficult population with regard to
compliance of follow-up, and therefore not having to
wait a few days for culture or TMA results increases
the rate of treatment and counseling.15-17 This is
especially important due to the link between TV and
other STIs.
Cost of testing is often a concern, especially in
low-income health care. Campbell et al.18 explored
the use of OSOM testing for TV as a way to decrease
labor costs. In a low-prevalence population of
women (N ¼ 1,009), 19 (2%) were positive for TV.18
Implementation of OSOM testing instead of WP
in a high-volume lab serving women with a low
prevalence of TV resulted in an increase in material
costs, but a 46.2% decrease in monthly labor costs.18
In addition, the study showed the OSOM test had
improved sensitivity (94.7%) compared with WP
(89.4%).18 Therefore, in labs with a high volume
of daily specimens, use of the OSOM test would
be more cost effective because microscopy lab costs
are decreased. Combined with the 10-15 minutes
required for analysis, the results favor an increased
rate of treatment, which is particularly important in
a population of women with a low prevalence
of TV.18
Reed et al.19 demonstrated an additional benefit
of the OSOM POC TV test: a change in patient
behavior. Using the teen clinic or emergency room
for recruitment, POC testing, such as the OSOM
test, increased awareness of the patients’ results
because they received them during the visit.19 The
www.npjournal.org
authors also noted that by doing in-clinic education
with result notification enabled patients to increase
their compliance with postvisit abstinence when
queried by follow-up phone call.19
The literature shows conclusively that the rates of
TV are high with the black non-Hispanic population
being especially vulnerable.4,5,12,16,17 The prevalence
of TV infection was shown to increase with age,
regardless of race.10,12 Along with these high rates
of TV, studies have demonstrated an increased
incidence of post‒TV infection HIV-1.1,5,10,16 Hence,
there is an identified priority need to increase the
rate of diagnosis of TV in high-risk populations. In
addition, TV can be found in asymptomatic patients
and in populations previously thought to be low
risk, such as adolescents. Therefore, increasing the
rate of TV diagnosis can address various health issues
associated with TV infection in both high- and
low-risk populations.
A diagnostic tool such as the OSOM TV test is a
major development in the identification, treatment,
and education of health behaviors regarding TV
infection. In addition, studies have shown the test to
be a cost-effective and time-efficient alternative to
culture. The addition of this test to the standard WP
using a step approach to testing may increase detec-
tion in a cost-effective manner. To address these same
issues of TV diagnosis and treatment, the following
study was undertaken to add further evidence to the
body of knowledge that the use of this step approach
to testing using the OSOM POC test is an improved
method of identification of TV in a high-risk pop-
ulation when TV is not initially identified by WP.
METHODS
Institutional review board approval for this study
was granted through a private university in the
Midwestern US. The researchers undertook a pilot
study with a single-site retrospective/prospective
design and a sample size of 50 participants. A sample
size of 50 achieves a power of approximately 0.80 to
minimally detect a Cohen’s D of approximately 0.80.
This estimation was based on an independent-
samples t-test with an associated control for a type I
error set at 0.05 using G*Power (version 3.1.9.2).20
Patients meeting the inclusion and exclusion criteria
were invited to participate. Consent was reviewed
The Journal for Nurse Practitioners - JNP 273
with all study subjects before obtaining signatures.
Time was given to the subject to review and ask
questions. These patients had a pelvic exam during
which 2 swabs were obtained. A WP was first
performed to assess for infection. If this was negative
the second swab was used for the POC testing.
Results of this testing were shared with the patient
and treatment provided as needed.
Population and Setting
The study population consisted of patients presenting
to this federally funded community health center
with a complaint of vaginal discharge and or irrita-
tion. The health center serves the urban insured and
uninsured patients of the city of St. Louis. The
patients of this health center are generally of a low
socioeconomic standing and tend to have high-risk
sexual behaviors.
Source of Data
After the study reached accrual, a chart review was
performed of all patients who consented to study
participation. The chart review was completed to
determine the method used for detection and safer
sex practices reported by the subjects. Information
was also obtained on age, race, ethnicity, insurance
status, education level, and history of STIs for all
subjects in the study.
Inclusion/Exclusion Criteria
All sexually active women  18 years of age who
presented to the health center over the designated
3-month period with a chief complaint of vaginal
discharge and irritation were invited to participate.
Excluded from the study were those patients who
had no complaint of vaginal discharge or irritation,
had negative TV testing since their last sexual activity,
reported always using condoms, reported no sexual
activity, or were < 18 years of age.
Procedures
Women meeting the inclusion criteria in the open
access center were first evaluated for TV using a saline
WP with green food dye added to enhance detection
of vaginal infections. If the WP was negative but the
patients’ symptoms suggested infection, an additional
POC test was used. If this POC test was negative,
274 The Journal for Nurse Practitioners - JNP
additional screening for STI was done in the lab as
per the usual protocol (see Figure). Data obtained in
this study were stored as an Excel spreadsheet with
patient identifiers removed.
Data were collected on age, ethnicity, race,
education level, history of STIs, method used for
detection, results of testing, safer sex practices, and
insurance status. Demographic data were obtained by
chart abstract completed by the research team. Data
on method used for detection and safer sex practices
were obtained through a review of the chart notes for
that visit by the researcher.
RESULTS
In looking at the 50 patients in the study we found
that those who tested positive for TV regardless of
method had a mean (SD) age of 44.2 (12.1) years.
Those who tested negative had a mean (SD) age of
32.3 (11.6) years. This difference is statistically sig-
nificant, t(48) ¼ -3.060, P ¼ .004 (independent-
samples t-test). Study subjects were predominantly
black non-Hispanic (n ¼ 43) with a high school
education (n ¼ 30) and had Medicaid for insurance
(n ¼ 27) (see Table).
Of the 50 subjects, 14% [n ¼ 7; 95% confidence
interval (CI) 4.38-23.62] tested positive using the
WP method alone. Among the 43 who tested
negative for TV with the WP method, an additional
5 (95% CI 2.72-20.48) tested positive using the POC
test. With the addition of the POC test, 24% (n ¼ 12;
95% CI 12.16-35.84) tested positive in total.
DISCUSSION
The addition of POC testing to WP yielded addi-
tional cases of TV (11.6%). Being able to increase this
detection resulted in more patients being treated and
a possible decrease in spread to the community. The
WP alone missed 5 of the 12 cases found in this
study. This finding is consistent with current research
showing the difficulties with detection using standard
methods.21 As anticipated, the number of high-risk
women who tested positive for TV was higher (24%)
than in a general sample (18/8%) studied in previous
research. The poor performance of the WP dem-
onstrates the need to change practice. The link
between TV and other serious health outcomes such
as HIV-1 and preterm labor suggests that a more
Volume 12, Issue 4, April 2016
Figure. Study protocol for detection of Trichomonas vaginalis infection.
Women with Women is quesoned
CC of vaginal on risk factors for STI
discharge/
and other vaginal
irritaon
infecons.

Vaginal exam is completed

including wet mount and culture
for
Gonorrhea/Chlamydia(GC/Ch)

Wet mount Wet mount posive

negave but for TV
clinical
presentaon
suspected to be
posive.

Paent informed of wet

mount results and treated.
POC tesng performed. GC/CH culture sent to lab. Pt
informed of GC/CH results
when received

POC test POC test

posive negave

GC/CH culture sent

Pt informed of results and
to lab. Paent
treated GC/CH culture
informed of
sent to lab. Paent is
culture results
informed of culture
when received
results when received

effective screening method is warranted. Adding the
POC test to the WP could increase this level of
detection in a cost-effective manner.
Using this combination of testing methods will
decrease missed cases of infection without having to
screen all women with the more costly POC test. In
addition, using the POC test will give the provider an
opportunity to diagnose the patient on the same day.
Women who are high risk for STI can be difficult
to follow.12 The ability to contact and treat these
patients after they have left the clinic is often limited.
Having the opportunity to diagnose the patient on
the same day gives an added opportunity for
education and can decrease the cost to the health
system and to the patient by avoiding another visit
counseling and treatment.
A limitation of this study is the small sample size,
although statistical significance was reached. A larger
size may yield a more robust analysis to better un-
derstand the usefulness of this step approach in the
high-risk female population. To determine the true
cost-effectiveness of this approach, more research is
needed on the cost burden of this infection to the
health care system. A more in-depth evaluation of the

www.npjournal.org The Journal for Nurse Practitioners - JNP 275

Table. Demographic Data 9. Stoner K, Rabe L, Meyn L, Hillier S. Survival of Trichomonas vaginalis
in wet preparation and on wet mount. Sex Transm Infect. 2013;89(6):
485-488.
Total for Positive 10. Meites E, Llata E, Weinstock H, et al. Trichomonas vaginalis in selected US
the Study or TV sexually transmitted disease clinics: testing, screening, and prevalence.
Sex Transm Dis. 2013;40(11):865-869.
Black 43 (86%) 10 (23%) 11. Workowski K, Bolan G. Sexually transmitted diseases treatment guidelines,
2015. MMWR Recomm Rep. 2015;64(3):1-134.
White non-Hispanic 7 (14%) 2 (28%) 12. Miller M, Liao Y, Gomez A, Gaydos C, D’Mello D. Factors associated with
a the prevalence and incidence of Trichomonas vaginalis infection among
Reported history of STI 20 (40%) 3 (15%) African American women in New York City who use drugs. J Infect Dis.
2008;197(4):503-509.
High school/GED 30 (60%) 5 (16%) 13. Roth A, Williams J, van der Pol B, et al. Changing sexually transmitted
infection screening protocol will result in improved case findings for
Some high school 17 (34%) 5 (29%) Trichomonas vaginalis among high-risk female populations. Sex Transm Dis.
2011;38(5):398-400.
College graduate/some college 3 (6%) 2 (66%) 14. Summers A. Identifying non-viral gynaecological conditions. Emerg Nurse.
[serial online]. 2011;18(9):26-30.
Medicaid 27 (54%) 6 (22%) 15. Huppert J, Mortensen J, Hobbs M, et al. Rapid antigen testing compares
favorably with transcription-mediated amplification assay for the detection
Private insurance 7 (14%) 2 (28%) of Trichomonas vaginalis in young women. Clin Infect Dis. 2007;45(2):
194-198.
No insurance 16 (32%) 4 (25%) 16. Krashin J, Koumans E, Markowitz L, et al. Trichomonas vaginalis prevalence,
a incidence, risk factors and antibiotic-resistance in an adolescent population.
Sexually transmitted infections (STIs) include chlamydia, gonorrhea, human
Sex Transm Dis. 2010;37(7):440-444.
papillomavirus, herpes simplex virus, syphilis, and Trichomonas vaginalis. 17. Swartzendruber A, Sales J, Brown J, DiClemente R, Rose E. Correlates of
incident Trichomonas vaginalis infections among African American female
adolescents. Sex Transm Dis. 2014;41(4):240-245.
18. Campbell L, Woods V, Lloyd T, Elsayed S, Church DL. Evaluation of the
cost of the providers’ time would be useful in future OSOMÒ Trichomonas Rapid Test versus wet preparation examination for
research to determine the true cost of implementing detection of Trichomonas vaginalis vaginitis in specimens from women
with a low prevalance of infection. J Clin Microbiol. 2008;46(10):
this protocol. 3467-3469.
19. Reed J, Simendinger L, Griffeth S, Kim HG, Huppert J. Point-of-care
testing for sexually transmitted infections increase awareness and
CONCLUSION short-term abstinence in adolescent women. J Adolesc Health. 2010;46(3):
270-277.
The main focus of this pilot study was to evaluate the 20. Faul G, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical
power analysis program for the social, behavioral, and biomedical sciences.
stepwise approach to TV testing in this high-risk Behav Res Methods. 2007;39(2):175-191.
21. Patel S, Wise W, Patel S, Ohl C, Byrd J, Estrada C. Systematic review of
female population. A step approach using the OSOM diagnostic tests for vaginal trichomoniasis. Infect Dis Obstet Gynecol. 2000;
test will increase detection levels and help prevent the 8(5-6):248-257.

continued spread of this all-too-common infection

while also allowing for a more cost-effective use of
materials and labor. By increasing detection of TV we
can improve health outcomes and decrease infection
rates in the community.
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Mariea Snell, DNP, FNP-C, is an assistant professor of nursing
at the Catherine McAuley School of Nursing of Maryville
University in Saint Louis, MO. She can be reached at msnell@
maryville.edu. Mary Lee Barron, PhD, FAANP, is an
associate professor at Southern Illinois University-Edwardsville in
Edwardsville, IL. Cathy Koetting DNP, NP-C, is an
assistant professor at Saint Louis University in Saint Louis,
MO. In compliance with national ethical guidelines, the
authors report no relationships with business or industry that
would pose a conflict of interest.
Acknowledgment
The authors thank Dr. Michael O’Conner for his support of this
research. We also thank Sekisui Diagnostics for donation of the
Trichomonas Rapid Test kits.
1555-4155/15/$ see front matter
© 2016 Elsevier, Inc. All rights reserved.
http://dx.doi.org/10.1016/j.nurpra.2015.11.025

276 The Journal for Nurse Practitioners - JNP Volume 12, Issue 4, April 2016