Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections

Obstet Gynecol. 2018 Dec;132(6):1412-1420. doi: 10.1097/AOG.0000000000002964.

Abstract

Objective: To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines.

Methods: Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology.

Results: Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P<.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2-10.8%), M genitalium (3.3-5.5%), C trachomatis (1.1-2.1%), and N gonorrhoeae (0-0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86-0.91 for T vaginalis, and 0.65-0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%).

Conclusion: Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.

Publication types

  • Observational Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Atypical Squamous Cells of the Cervix / pathology
  • Cervical Intraepithelial Neoplasia / diagnosis*
  • Cervical Intraepithelial Neoplasia / virology
  • Cervix Uteri / microbiology
  • Chlamydia Infections / diagnosis
  • Chlamydia trachomatis
  • Early Detection of Cancer / methods
  • Female
  • Gonorrhea / diagnosis
  • Humans
  • Middle Aged
  • Mycoplasma Infections / diagnosis
  • Mycoplasma genitalium
  • Neisseria gonorrhoeae
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology*
  • Patient Acceptance of Health Care
  • Postal Service
  • Self Care
  • Sexually Transmitted Diseases / diagnosis*
  • Sexually Transmitted Diseases / microbiology
  • Specimen Handling / methods*
  • Squamous Intraepithelial Lesions of the Cervix / diagnosis
  • Trichomonas Vaginitis / diagnosis
  • Trichomonas vaginalis
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / virology
  • Vagina / microbiology