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Obstetrics and gynaecology
Original research
Assessing the feasibility of a rapid, high-volume cervical cancer screening programme using HPV self-sampling and digital colposcopy in rural regions of Yunnan, China
  1. Andrew Goldstein1,2,
  2. Lena Sophia Goldstein3,
  3. Roberta Lipson4,
  4. Sarah Bedell2,
  5. Jue Wang4,
  6. Sarah A Stamper5,
  7. Gal Brenner6,
  8. Gail R Goldstein7,
  9. Karen Davis O'Keefe8,
  10. S Casey O'Keefe9,
  11. McKenna O'Keefe10,
  12. Tierney O'Keefe8,
  13. Amelia R Goldstein11,
  14. Anna Zhao4
  1. 1Obstetrics and Gynecology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA
  2. 2The Center for Vulvovaginal Disorders, Washington, DC, USA
  3. 3Yale University, New Haven, Connecticut, USA
  4. 4Beijing United Family Hospitals and Clinics, Beijing, China
  5. 5Department of Psychological and Brain Sciences, Johns Hopkins University, Baltimore, Maryland, USA
  6. 6MobileODT, Tel Aviv, Israel
  7. 7Annapolis Dermatology Center, Annapolis, Maryland, USA
  8. 8Bellingham Bay Family Medicine, Washington, DC, USA
  9. 9Pacific Northwest Urology Specialists, Washington, DC, USA
  10. 10Engineering, University of California Berkeley, Berkeley, California, USA
  11. 11Duke University, Durham, North Carolina, USA
  1. Correspondence to Dr Andrew Goldstein; obstetrics{at}yahoo.com

Abstract

Objective Implementation of a novel, rapid, high-volume, see-and-treat cervical cancer screening programme using self-swab human papillomavirus (HPV) testing and digital colposcopy in underserved regions of Yunnan China.

Design 480–980 women per day self-swabbed for high-risk HPV (hrHPV+). Four careHPV machines (Qiagen) were run simultaneously to test the specimens. All hrHPV+ patients were contacted the same day and digital colposcopy was performed with the enhanced visual assessment system (MobileODT). Digital images were obtained, and all suspected lesions were biopsied and then treated.

Setting Rural and underserved areas of the Yunnan province, Kunming municipality.

Participants 3600 women, mean age 50.2 years, who had never been screened for cervical cancer. The women were of the Yi, Hui, Dai and Han ethnicities.

Interventions Cryotherapy was performed on all lesions suspicious for cervical intraepithelial neoplasia (CIN) 1 and loop electrosurgical excision procedure was performed on all lesions suspicious for ≥CIN2. Endocervical curettage was performed if the transformation zone was not fully visualised.

Results 216 women (6%) were hrHPV+. 168 underwent same-day colposcopy (23 CIN1, 17≥CIN2). Digital colposcopy was able to identify 15 of 16 (93.8%)≥CIN2 lesions.

Conclusions This study illustrates a high-volume, rapid and practical strategy that can be used to screen and treat an ethnically diverse group of Chinese women. First, HPV self-sampling allows large numbers of women to be screened rapidly and relatively inexpensively. Only hrHPV+ women will then require further evaluation. Digital colposcopy is then performed on hrHPV+ women with a portable digital colposcope. The high-resolution images obtained can facilitate appropriate same-day treatment as they are able to accurately distinguish between CIN1 and ≥CIN2 lesions.

  • colposcopy
  • gynaecological oncology
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-035153

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    Footnotes

    • Twitter @andrewgoldstei2

    • Contributors AG: Study conception, study design, data acquisition, data analysis drafting work, final approval, agreement to be accountable for the work. LSG: Study conception, study design, data acquisition, revising work, final approval, agreement to be accountable for the work. RL: Study conception, study design, data acquisition, revising work, final approval, agreement to be accountable for the work. SB: Data acquisition, revising work, final approval, agreement to be accountable for the work. JW: Data acquisition, revising work, final approval, agreement to be accountable for the work. SAS: Data acquisition, revising work, final approval, agreement to be accountable for the work. GB: Data acquisition, revising work, final approval, agreement to be accountable for the work. GRG: Study conception, study design, data acquisition, drafting work, final approval, agreement to be accountable for the work. KDO’K: Data acquisition, revising work, final approval, agreement to be accountable for the work. SCO’K: Data acquisition, revising work, final approval, agreement to be accountable for the work. MO’K: Data acquisition, revising work, final approval, agreement to be accountable for the work. TO’K: Data acquisition, revising work, final approval, agreement to be accountable for the work. ARG: Study conception, study design, data acquisition, revising work, final approval, agreement to be accountable for the work. AZ: Study design, data acquisition, revising work, final approval, agreement to be accountable for the work.

    • Funding This work was supported by the Gynecologic Cancer Research Foundation, the United Foundation for China’s Health, and regional health offices of the Peoples Republic of China.

    • Competing interests AG: President of the Gynecologic Cancer Research Foundation: a non-profit 501(c)3 corporation. Received research funding from the Gynecologic Cancer Research Foundation. RL: Director, United Foundation for China’s Health, a non-profit 501(c)3 corporation. Investor, MobileODT. GB: Was an employee of MobileODT during the data acquisition phase of this study. GRG: Member, Board of Directors, the Gynecologic Cancer Research Foundation: a non-profit 501(c)3 corporation. AZ: employee, United Foundation for China’s Health, a non-profit 501(c)3 corporation.

    • Patient consent for publication Not required.

    • Ethics approval United Family Hospitals Institutional Review Board Beijing, China (approval number: UFHIRB. E2018-0002).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available in a public, open access repository. Extra data can be accessed via the Dryad data repository at http://datadryad.org/ with the https://doi.org/10.5061/dryad.8w9ghx3gr.