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Self-obtained Vaginal Swabs for Diagnosis of Treatable Sexually Transmitted Diseases in Adolescent Girls
Kim Smith, MT(ASCP);
Kathy Harrington, MAEd, MPH;
Gina Wingood, ScD, MPH;
M. Kim Oh, MD;
Edward W. Hook III, MD;
Ralph J. DiClemente, PhD
Arch Pediatr Adolesc Med. 2001;155:676-679.
ABSTRACT
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Objective To ascertain the acceptability of testing and prevalence of 3 readily
treatable sexually transmitted diseases (STDs) (infections with Neisseria gonorrhoeae, Chlamydia trachomatis,
and Trichomonas vaginalis) with the use of patient-obtained
vaginal swabs.
Study Design Study participants at each initial session were asked to provide self-obtained
vaginal swabs for ligase chain reaction testing to detect N gonorrhoeae and C trachomatis, and for culture
of T vaginalis.
Setting Behavioral intervention sessions with African American adolescent girls
in a nonclinical program to reduce risk of STDs, human immunodeficiency virus
infection, and pregnancy.
Results All study participants were offered their choice of STD screening in
the context of a traditional pelvic examination or using self-obtained vaginal
swabs. All eligible participants chose self-administered vaginal swabs. Of
the 512 participants examined at their initial study visit, 28.7% were found
to be infected with 1 or more treatable STDs (5.3% with N gonorrhoeae, 17.8% with C trachomatis, and
12.9% with T vaginalis).
Conclusions With the use of newer detection systems, STDs can be readily detected
in nonclinical settings with the use of self-obtained vaginal swabs, providing
new opportunities for efforts to control STDs.
INTRODUCTION
TREATABLE sexually transmitted diseases (STDs) caused by Trichomonas vaginalis, Chlamydia trachomatis,
and Neisseria gonorrhoeae are relatively common among
sexually active young women and may lead to serious complications and sequelae.
Infections with C trachomatis and N gonorrhoeae are the 2 most common reportable bacterial STDs in the
United States,1 and vaginal trichomoniasis2 is more common than chlamydial and gonococcal infection.
Each of these infections is also an important contributor to the STD-related
morbidity in women. Gonococcal and chlamydial infections cause pelvic inflammatory
disease, ectopic pregnancy, infertility, and perinatal and congenital infections,
and cost millions of dollars in health care costs.2, 3 Trichomonas vaginalis infection is a common cause of symptomatic
vaginal discharge and has been implicated in preterm birth.2, 4
Moreover, recent studies have demonstrated increased efficiency of transmission
of human immunodeficiency virus (HIV) in the presence of coinfection with
bacterial STDs or trichomoniasis.5, 6, 7
However, each of these infections often remains undiagnosed because many infected
women have mild, nonspecific symptoms or are asymptomatic.2
As a result, screening for bacterial STDs and trichomoniasis is a critical
component of control efforts.
Until recently, diagnosis of these STDs required a pelvic examination.
The development of diagnostic nucleic acid amplification technology has made
chlamydial and gonococcal diagnoses in women possible in circumstances in
which the usual endocervical specimen collection is difficult. Self-obtained
vaginal specimens for diagnosis of genital infections have been used successfully
in research settings8, 9, 10;
however, few data have been published on patient-obtained vaginal specimens
for STD diagnosis in teenage girls.11
This article reports the utility of patient-obtained vaginal swabs as
tools for STD diagnosis in a nonclinical setting where they are collected
without a pelvic examination according to instruction by nonclinicians. Questions
we sought to address were 2-fold: (1) Are sexually active adolescent girls
willing and able to obtain their own vaginal specimens? (2) Can the specimens
obtained in a nonclinical setting be processed for delivery to the laboratory
for appropriate assays for the identification of C trachomatis, N gonorrhoeae, and T vaginalis infections?
SUBJECTS AND METHODS
SUBJECT POPULATION
From December 1996 through April 1999, project recruiters screened 1130
teenage girls in adolescent and school-based primary care clinics and in health
education classes at local high schools to assess eligibility for STD/HIV
prevention intervention. Recruiters presented a brief description of a young
women's health study, then assessed the eligibility of those expressing an
interest in participating by means of a short questionnaire. Adolescents were
eligible to participate in the study if they were African American girls,
were between the ages of 14 and 18 years at the time of enrollment, had been
sexually active (vaginal or anal sex) in the previous 6 months, and provided
written informed consent. In this study, African American female teenagers
were selected as the target population because of reports of high escalating
risk for HIV and STD.12, 13, 14
The recruitment sites were in neighborhoods characterized by high rates of
unemployment, substance abuse, violence, and STDs.
STUDY DESIGN
Subjects recruited from a variety of settings were informed, via telephone
and mailed brochure, about the methods of the study, including surveys, interviews,
specimen collection, incentives, workshops, and follow-up. These adolescents
were then invited to ask questions about the study and to sign a consent form
to participate. For the study, 4 intervention workshops and data collection
sessions were held in a local clinic facility on Saturdays. For baseline data
collection and each workshop, participants received a $20 cash incentive.
The study protocol was reviewed by the university's Institutional Review Board
Committee on Human Research before implementation of the study.
SPECIMEN COLLECTION METHODS
During the baseline data information collection session and before randomization
to a behavioral STD/HIV risk-reduction intervention, each adolescent was instructed
by a nonclinician research assistant to obtain 2 vaginal swabs for STD testing
by means of a written protocol. Research assistants instructed adolescents
in appropriate procedures for collecting vaginal specimens. During a preliminary
2-hour training session, research assistants were instructed on the methods
used in obtaining self-obtained vaginal swabs, the efficacy of this procedure
for STD analysis relative to pelvic examination, and how to address questions
posed by participants.
The research assistant explained the purpose of collecting the vaginal
specimens, presenting a discussion biased toward self-obtained vaginal specimen
collection rather than specimen collection by a clinician on a pelvic examination
table. The discussion included the relative advantages of self-obtained vaginal
specimens, such as being under their control, less painful, not as invasive,
and more convenient. For participants preferring not to collect vaginal swabs,
free pelvic examination appointments for specimen collection were available
for girls the following week at a local adolescent clinic. Choosing the pelvic
examination option would still allow for study entry and receipt of the $20
incentive. After research assistants described the insertion procedure to
the adolescents and answered any questions regarding it, participants were
asked about their willingness to collect self-obtained vaginal swabs. Adolescents
completed specimen collection within 3 to 4 minutes in a private clinical
examination room. Vaginal swabs were not collected from adolescents in their
third trimester of pregnancy or 6 weeks postpartum; these adolescents provided
a first-void urine specimen for ligase chain reaction testing.
For specimen collection, each participant was asked to obtain 2 vaginal
specimens by sequentially inserting 2 sterile Dacron-tipped swabs about 2.5
in or as far as comfortable into the vagina, rotating them for 15 to 30 seconds,
and removing them. After specimen collection, the first swab was placed in
a specimen transport tube for subsequent ligase chain reaction testing (LCx
Probe System for N gonorrhoeae and C trachomatis assays; Abbott Laboratories, Diagnostics Division, Abbott
Park, Ill), and the second swab was used to inoculate culture medium for T vaginalis (InPouch TV Test; BioMed Diagnostics Inc, Santa
Clara, Calif).
Ligase chain reaction specimens were stored at 4°C until delivered
to the laboratory. Pouches for T vaginalis culture
were immediately incubated at 37°C. All specimens were transported to
the laboratory in insulated containers within 48 hours.
LABORATORY METHODS
Study participants were examined for 3 prevalent sexually transmitted
organisms: N gonorrhoeae, C trachomatis, and T vaginalis.8, 9, 10
On receipt in the laboratory, cultures for T vaginalis
were incubated at 37°C and read daily until the fifth day after inoculation.
Cultures were considered positive on the basis of identification of motile
trichomonads within the pouch.8 Swab specimens
for ligase chain reaction were processed immediately on receipt in the laboratory.
Ligase chain reaction assays for C trachomatis and N gonorrhoeae were performed according to the manufacturer's
instructions.9, 10
RESULTS
Of the 609 eligible adolescents referred to intervention workshops,
522 (85.7%) attended and agreed to participate in the study. Of the 522 adolescents,
512 were asked to collect vaginal swabs. Ten (2.0%) were excluded because
they were known to be in their third trimester of pregnancy and were not asked
to provide vaginal swabs. Of the 87 recruited teens (14.3%) who did not participate,
31% (27 subjects) could not be reached because of incorrect contact information
given at screening, 29% (25) stated that they were not interested in taking
part in the health promotion program, 22% (19) had employment or child care
conflicts, 9% (8) expressed interest but never showed up to enroll, 3% (3)
declined because of chronic illness, 3% (3) were incarcerated after the initial
referral, and 2% (2) were not permitted to participate by their parents. No
participant cited vaginal swab screening as a specific reason for not participating.
Of the 512 participants asked to provide vaginal swabs, none declined.
As shown in Table 1, participants
were at high risk for STD acquisition and pregnancy: 39.3% reported at least
1 previous pregnancy, and 9.4% reported multiple partners in the 6 months
before enrollment. Overall, 147 participants (28.7%) had at least 1 treatable
STD detected, and 28 (5.5%) were coinfected with 2 or more pathogens (Table 2). Infection rates were 17.8% for C trachomatis, 5.3% for N gonorrhoeae, and 12.9% for T vaginalis. Age distribution
of subjects with infections is shown in Figure
1.
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Table 1. Population Characteristics
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Table 2. Laboratory Test Results of Subjects at Enrollment (Baseline)
Visit*
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Prevalence of sexually transmitted diseases by participant age (N
= 512).
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COMMENT
In this study, sexually active teens were willing to obtain their own
vaginal swab specimens for STD diagnosis. No participant declined to obtain
the vaginal swabs or reported difficulty in doing so. Some aspects of the
study methods may have influenced participants in favor of the self-obtained
specimen collection over the traditional pelvic examination collection. The
convenience of immediate swab collection as opposed to having to make another
trip to a clinic for specimen collection on a pelvic examination table, as
well as presenting the self-obtained method first with all of the relative
advantages, may have influenced some participants to prefer the self-obtained
method. Perhaps, given a choice of an immediate pelvic examination or immediate
self-obtained swabs, some girls may have chosen the pelvic examination. However,
with no participants opting for the pelvic examination or refusing specimen
collection, collection of vaginal swab specimens for STD screening appears
to be readily acceptable to this group of high-risk adolescents.
Nearly all participants were asymptomatic at the time of enrollment,
yet unsuspected gonorrhea, Chlamydia, and Trichomonas infections were common. Since we did not compare the prevalence
of infection detected by means of patient-obtained specimens with the results
of testing with specimens collected by clinicians in the context of a speculum-guided
genital examination, it is possible that some infections were missed by allowing
participants to collect their own specimens. On the basis of our own earlier
work comparing performance of patient-obtained vaginal swabs with that of
clinician-obtained specimens, as well as the work of others,8, 9, 10, 15, 16
we suspect that the diminution of sensitivity was slight, if any.
These data add to growing literature that suggests that, for women,
patient-obtained vaginal swabs are adequate and appropriate specimens for
STD screening at sites or in situations where pelvic examinations are not
otherwise required.
In some situations, urine may be a favored analyte for gonococcal and
chlamydial screening; however, the sensitivity of urine culture for T vaginalis is poor.17 In
addition, transport and laboratory processing of swab specimens for STD diagnosis
is simpler (no aliquoting or centrifugation is required) than for urine. Thus,
patient-obtained vaginal swab specimens, analyzed by newly developed nucleic
acid amplification assays, enhance the likelihood that individuals will provide
a specimen and increase the potential for detecting asymptomatic infection.
This method should be evaluated further as a potential tool for STD screening
and control efforts.
AUTHOR INFORMATION
Accepted for publication January 8, 2001.
This study was supported by grants R01 MH 54412 from the Center for
Mental Health Research on AIDS, National Institute of Mental Health, and U
AI 38514 from the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Bethesda, Md.
We thank Jane Schwebke, MD, and her laboratory for performing Trichomonas cultures for this study.
From the Division of Infectious Diseases, Department of Medicine (Ms
Smith and Dr Hook), and the Department of Pediatrics (Ms Harrington and Dr
Oh), University of Alabama at Birmingham; Rollins School of Public Health,
Emory University, Atlanta, Ga (Drs Wingood and DiClemente); and Emory/Atlanta
Center for AIDS Research (Drs Wingood and DiClemente).
Corresponding author and reprints: Kim Smith, MT(ASCP), Division
of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham,
229 Tinsley Harrison Tower, 1900 University Blvd, Birmingham, AL 35294-0006
(e-mail: krs{at}uab.edu).
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