Many sexually transmitted infections (STIs) are asymptomatic in the lower genital tract of women and, if undiagnosed and untreated, may cause upper tract complications.1 2–5 6,7 Chlamydia trachomatis (CT ) and Neisseria gonorrhoeae (NG ).8 CT infection among young, sexually active women in both clinical and nontraditional settings.8,9 CT and NG infections, with participants reporting high levels of acceptability, ease, and comfort during the self-collection process.10–12
Despite widespread evidence on the diagnostic effectiveness of vaginal self-sampling for the detection of STI's using nucleic acid amplification tests,13–15 CT and NG with a transcription-mediated amplification RNA-based assay, Aptima Combo 2 (AC2; Hologic, Inc, San Diego, CA).
MATERIALS AND METHODS
Study Design
A total of 189 participants aged 16 to 41 years were enrolled in the study: 110 women from a street youth clinic and 79 women from a therapeutic abortion clinic. Women signed a consent form for the collection of a PCV sample using an Aptima swab and an SCV sample using HerSwab, as outlined on the consent form approved by the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The order of physician collection and self-collection was computer randomized. After explanation of the study, the research coordinator demonstrated steps for proper self-collection using HerSwab, provided participants with written and visual instructions (Fig. 1 ), clarified any outstanding questions, and recorded STI history and symptoms. Participants were classified as symptomatic if they reported symptoms such as discharge, dysuria, and pelvic pain. Each participant then collected an SCV sample using HerSwab, and a physician collected a PCV sample using an Aptima vaginal swab. After collection with HerSwab, women turned the handle of the device to fully retract the brush tip back into the shaft and placed the device back in its original packaging.
Figure 1: Procedure for vaginal self-sampling using the HerSwab device.
Questionnaire
Each participant was asked to anonymously complete a 2-page written questionnaire after collection. The first section consisted of a 5-point Likert scale questionnaire where participants indicated ease (for steps 2–7) and comfort (for steps 3–6) of self-collection (Fig. 1 ) using HerSwab. Additional open-ended items on the questionnaire included the following: whether the instructions were easy to follow, whether participants preferred physician or self-collection, participants' reasons for preferring self-collection or physician collection, whether participants would consider self-sampling at home, and whether there was anything that participants would change about the device to facilitate ease and/or comfort.
Laboratory Testing
Samples of SCV and PCV were transported to the Infections Research Laboratory at St Joseph's Healthcare Hamilton on the day of collection. Self-collected vaginal samples were transported dry in their original packaging, whereas PCV samples were transported in 2.9 mL of Aptima Specimen Transport Media (STM). Upon arrival in the laboratory, within 24 hours of collection, the HerSwab device handle was turned to expose the brush, and the plastic brush tip was snapped off into an Aptima tube containing 2.9 mL of STM. The brush tip remained in the Aptima STM tube for 48 hours and was subsequently removed from the STM tube using a sterile swab or pipette tip, before testing to prevent interference with the probe of the automated instrument. All samples in STM were inverted and tested for CT and NG using the AC2 assay on the Panther automated system within 72 hours of collection, as per the manufacturer's instructions. After testing all SCV and PCV samples on AC2, a subset of 6 discordant and 6 concordant specimen pairs were further tested for β-actin DNA as a quantitative internal control for the amount of specimen collected in each sample type. DNA from 250 μL of samples preserved in Aptima STM was extracted with Qiagen MinElute spin columns and was based on the AmpliLute Liquid Media Extraction Kit (Roche, Pleasanton, CA), followed by quantitative polymerase chain reaction using previously published β-actin primers.16
Statistical Analysis
Means and SDs were calculated to express results from Likert items on patient questionnaires. Questionnaire responses were recorded such that 4–5 meant “easy/comfortable-very easy/comfortable,” 3 meant “neutral,” and 1–2 meant “very difficult/uncomfortable-difficult/uncomfortable.” Descriptive statistics were performed on patient demographics and open-ended questionnaire items. Unpaired Student t test was used to test for significance of (a ) presence or absence of symptoms, (b ) history of an STI, (c ) swab order randomization, and (d ) preference for self-collection or physician collection on mean questionnaire responses for ease and comfort for each step of self-collection. An unpaired Student t test was also used to determine significance of age on preference for self-collection and on whether participants would consider self-collection at home. χ 2 Tests of independence were performed to test pairs of nominal variables, namely, the presence/absence of symptoms and presence/absence of a history of an STI versus a preference for self-collection and whether participants would consider self-collection at home. Results of AC2 testing were collated in a secure database, and agreement between sample types was assessed as raw overall agreement and as agreement beyond chance (κ ) along with 95% confidence intervals. A paired t test was performed to determine significant differences in quantity of β-actin in CT -concordant versus CT -discordant SCV/PCV pairs.
RESULTS
Demographics
Participants from the street youth clinic ranged in age from 16 to 26 years (mean [SD], 23.5 [4.7] years), with 24.5% (27/110) presenting with STI symptoms and 43.6% (48/110) having history of an STI. Participants from the therapeutic abortion clinic ranged in age from 16 to 41 years (mean [SD], 24.2 [5.3] years), with none experiencing STI symptoms and 31.6% (25/79) having history of an STI.
Questionnaire Results
The questionnaire revealed that instructions were easy to follow for 97.1% (169/175) of respondents; 80.9% (140/173) preferred self-collection over physician collection; and 79.7% (137/172) would consider self-collection at home (Table 1 ). In answer to the ease related to self-collection of each step, 96.2% (177/184) found the insertion of the device into the vagina to be easy or very easy, and 93.4% (171/183) found the turning of the device handle while inside the vagina to be easy, very easy, or neither easy nor difficult. Withdrawing the device from the vagina was easy or very easy for 89.6% (164/183) of respondents. The presence of symptoms, history of an STI, swab order randomization, and preference for self-collection versus physician collection were not significantly related to ease and comfort of collection with HerSwab, as determined by Student t tests of mean questionnaire responses for each step of self-collection. Age was not significantly related to preference for self-collection versus physician collection (t = 0.13, P = 0.90) or to whether participants would consider self-collection at home (t = 0.022, P = 0.98). χ 2 Tests of independence revealed that a history of an STI (χ 2 = 1.489, P = 0.22) or the presence of symptoms (χ 2 = 0.519, P = 0.47) were not significantly related to a preference for self-collection versus physician collection. Similarly, neither a history of STI nor the presence of symptoms was related to whether participants would consider self-collection at home (χ 2 = 0.807 [P = 0.37] and χ 2 = 0 [P = 1], respectively).
TABLE 1: Summary of Ease and Comfort of Each Step of Vaginal Self-Collection Using the HerSwab Device
The questionnaire provided an opportunity for women to answer why they preferred self-collection with the HerSwab. Of the 123 women who preferred self-collection and stated a reason, increased comfort (n = 50), privacy (n = 38), and convenience (n = 21) were primarily cited. Additional reasons for preferring self-collection included faster sampling, an opportunity for self-education on own body, lack of comfort with male doctors, greater access to screening for people with disabilities, and a reduction of physical and psychological stress. The 10.4% (18/173) of respondents that preferred physician collection over self-collection cited concerns about collecting an inadequate sample (n = 12) and that self-collection was not as comfortable as collection by a physician (n = 6). Feedback with the design of the HerSwab device was generally positive. However, some suggestions to make self-sampling easier and more comfortable included making the brush bristles softer (n = 10) and including arrows on the handle of the device to better indicate the direction of turning (n = 3).
Testing Comparison of Sample Types
Overall prevalence of infection was 10.6% (20/189) for CT and 2.6% (5/189) for NG . Prevalence in the street youth clinic was 12.7% for CT and 4.5% for NG , and 7.6% for CT and 0% for NG in the therapeutic abortion clinic. Overall agreement between PCV and SCV samples tested by AC2 was 94.7% (90.2%–97.3%; κ = 0.64 [0.43–0.85]) for CT and 98.4% (95.1-99.6; κ = 0.56 [0.13-1]) for NG (Table 2 ). HerSwab detected 4 more CT and 3 more NG infections than PCV samples collected with conventional Aptima vaginal swabs. Quantity of β-actin DNA, measured in number of log copies/mL (data not shown), was not significantly different between SCV and PCV samples (t = −0.105, P = 0.918), or when comparing groups of CT -concordant and CT -discordant specimen pairs (mean difference, −0.342 [0.516] in concordant pairs; mean difference, 0.265 [1.74] in discordant pairs; data not shown).
TABLE 2: Agreement of CT and NG Infections by Method of Collection
DISCUSSION
As with previous studies of self-collection,10–12 10–12,17–19 CT and NG (Table 2 ). Similar agreement has been previously observed in other studies comparing SCV swabs against clinician-collected samples.11,20,21
The few extra positives by HerSwab (4 for CT and 3 for NG , Table 2 ) may be due to random chance when dealing with a small number of positives or due to differences in the collection devices. There are distinct differences between the Dacron tip of an Aptima vaginal swab and the soft plastic bristles on the end of the HerSwab device. The HerSwab did not collect significantly more cells compared with the Aptima vaginal swab, as determined by the quantity of β-actin DNA in concordant and discordant pairs. Differences were not related to order of collection. One important limitation of this study is the sample size. However, the HerSwab did identify as many or more positives than the traditional Aptima swab.
Vaginal self-collection kits that require the patient to insert the swab into a transport media may discourage women from self-collection for fear of spilling the fluid on themselves (unpublished data). In a study among female soldiers, researchers found no statistical difference between swabs transported dry or transported in liquid media, demonstrating that polymerase chain reaction testing of vaginal swabs transported dry can be an accurate diagnostic method for detecting CT and NG .22 CT .23 24
In conclusion, the HerSwab was well accepted in terms of ease and comfort for vaginal self-sampling in this population of young women avoiding pelvic examination, demonstrating good agreement compared with a PCV sample. Future studies are warranted for the diagnosis of other STIs using this collection device.
We would like to note that the HerSwab device is still investigational and not yet Food and Drug Administration approved.
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