OBJECTIVE
Cytology in combination with high-risk human papilloma virus (HPV) testing is an effective method for cervical cancer screening, but it is resource intensive, creating barriers for vulnerable populations often not screened.1,2 The Food and Drug Administration approved HPV testing as an alternative to cytology as a primary screening method for precancerous cervical lesions and cervical cancer.3,4 Self-collected, instead of clinician-collected, vaginal HPV swabs are a feasible, cost-effective tool that may facilitate screening for populations often missed because of unstable housing, substance use, incarceration, or resource limitations.5
The purpose of this study was to determine the acceptability and accuracy of self-collected vaginal swabs for detecting high-risk HPV among women in temporary residential programs.
STUDY DESIGN
This cross-sectional study evaluated the accuracy and acceptability of self-collected vaginal swabs to detect high-risk HPV compared with physician-collected cervical swabs and cervical ThinPrep Papanicolaou tests (Hologic, Inc., Marlborough, MA) among women from 3 temporary residential programs. The programs include an emergency shelter for 26 families and 2 22-bed recovery programs at a Boston community health center.
Women were recruited at an educational program on cervical cancer screening from August 2013 to March 2014 and were eligible if they were at least 21 years of age and able to provide informed consent in English. Each participant received verbal instructions, a pictorial diagram, and private space to collect a vaginal swab. A physician then performed a speculum examination, cervical swabs, and a cervical ThinPrep Papanicolaou test. Swabs were analyzed using the polymerase chain reaction–based Hybrid Capture 2 system (Qiagen, Gaithersburg, MD). Participants were asked to complete a survey to assess perception of the self-swab process.
We estimated 44 women were needed to achieve 80% power to detect a sensitivity of 92% for self-collected compared with physician-collected swabs at a significance level of P = .05. Our institutional review board approved the study; participants provided written informed consent.
RESULTS
Forty-seven women with a median age of 31.4 years (interquartile range, 26.8–42.4) participated. Fifteen self-collected swabs (31.9%) and 13 physician-collected swabs (27.7%) had high-risk HPV detected (Table 1).
TABLE 1.
Comparison of self-collected and physician-collected HPV swabs
| Variable |
Result of physician- collected HPV swabs |
|
|---|---|---|
| Result of self-collected HPV swabs | Detected | Not detected |
| Detected | 11 | 4 |
| Not detected | 2 | 30 |
HPV, human papilloma virus.
Harvey. HPV self-swab among women in temporary residential programs. Am J Obstet Gynecol 2016.
Using the physician-collected swab as the gold standard, the self-collected swab had a sensitivity of 84.6% (95% confidence interval [CI], 54.6–98.1%), specificity of 88.2% (95% CI, 72.6–96.7%), positive predictive value of 77.3% (95% CI, 44.9–92.2%), and negative predictive value of 93.8% (95% CI, 79.2–99.2%). Eight Papanicolaou tests (17.0%) were abnormal. Of the 4 atypical squamous cells of uncertain significance results, 3 physician-collected swabs (75.0%) and 3 self-collected swabs (75.0%) detected high-risk HPV. Among the 4 low-grade squamous intraepithelial lesion results, high-risk HPV was detected by 2 physician-collected swabs (50.0%) and 3 self-collected swabs (75.0%).
Among women who stated a preference for the method of swab collection, 91.9% reported self-collected swabs were more private, 86.8% found them easier, 74.2% found them more comfortable, and 65.5% preferred them over physician-collected swabs. Barriers to screening included incarceration, substance abuse, and lack of insurance.
CONCLUSION
In our study of women in temporary residential programs, vaginal self-swab for HPV detection was a well-accepted and accurate method for cervical cancer screening. Although most participants found self-collection more private and easier, fewer women preferred self-collection. This apparent discrepancy may be due to concerns of incorrect self-collection, as informally reported by some participants. Future efforts should increase awareness about the accuracy of self-collection and its utility in reaching populations missed by conventional screening.
Acknowledgments
We thank the physicians, staff, and study participants of The Dimock Center (Boston, MA) for their support and collaboration.
This study was supported by Harvard Catalyst–The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic health care centers. The cost of human papilloma virus testing was supported by the Beth Israel Deaconess Medical Center OBGYN Foundation.
Footnotes
The authors report no conflicts of interest.
Contributor Information
Lara F. B. Harvey, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA 02215.
Sarah H. Averbach, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA 02215.
Michele R. Hacker, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA 02215.
Anna M. Modest, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA 02215.
Jennifer Scott, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Division of Women’s Health, Brigham and Women’s Hospital, Boston, MA 02115.
Hope A. Ricciotti, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA 02215, hricciot@bidmc.harvard.edu.
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