Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda

Gad Murenzi, Jean Claude Dusingize, Theogene Rurangwa, Jean D.Amour Sinayobye, Athanase Munyaneza, Anthere Murangwa, Thierry Zawadi, Tiffany M. Hebert, Pacifique Mugenzi, Adebola A. Adedimeji, Leon Mutesa, Kathryn Anastos, Philip E. Castle

Research output: Contribution to journalArticle

Abstract

Introduction The optimal method(s) for screening HIV-infected women, especially for those living in sub-Saharan Africa, for cervical precancer and early cancer has yet to be established. Methods and analysis A convenience sample of >5000 Rwandan women, ages 30-54 years and living with HIV infection, is being consented and enroled into a cross-sectional study of cervical cancer screening strategies. Participants are completing an administered short risk factor questionnaire and being screened for high-risk human papillomavirus (hrHPV) using the Xpert HPV assay (Cepheid, Sunnyvale, California, USA), unaided visual inspection after acetic acid (VIA) and aided VIA using the Enhanced Visual Assessment (EVA) system (Mobile ODT, Tel Aviv, Israel). Women positive for hrHPV and/or by unaided VIA undergo colposcopy, which includes the collection of two cervical specimens prior to undergoing a four-quadrant microbiopsy protocol. The colposcopy-collected specimens are being tested by dual immunocytochemical staining for p16INK4a and Ki-67 (CINtec PLUS Cytology, Ventana, Tucson, Arizona, USA) and for E6 or E7 oncoprotein for 8 hrHPV genotypes (HPV16, 18, 31, 33, 35, 45, 52 and 58) using the next-generation AV Avantage hrHPV E6/E7 test (Arbor Vita Corporation, Freemont, California, USA). Women with a local pathology diagnosis of cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) or pathology review diagnosis of CIN grade three or more severe (CIN3+) will receive treatment. Clinical performance and cost-effectiveness (eg, sensitivity, specificity and predictive values) of different screening strategies and algorithms will be evaluated. Ethics and dissemination The protocol was approved by local and institutional review boards for human subjects research. At the completion of the study, results will be disseminated to the scientific community through peer-reviewed publication and to the Rwandan stakeholders through an external advisory panel.

Original languageEnglish (US)
Article numbere020432
JournalBMJ Open
Volume8
Issue number8
DOIs
StatePublished - Aug 1 2018

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Rwanda
Early Detection of Cancer
Uterine Cervical Neoplasms
HIV
Technology
Acetic Acid
Colposcopy
Cervical Intraepithelial Neoplasia
Thuja
Pathology
Africa South of the Sahara
Research Ethics Committees
Oncogene Proteins
Israel
Ethics
HIV Infections
Cost-Benefit Analysis
Cell Biology
Publications
Cross-Sectional Studies

Keywords

  • cervical cancer
  • cervical intraepithelial neoplasia
  • gynaecology
  • human papillomavirus (hpv)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Murenzi, G., Dusingize, J. C., Rurangwa, T., Sinayobye, J. D. A., Munyaneza, A., Murangwa, A., ... Castle, P. E. (2018). Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda. BMJ Open, 8(8), [e020432]. https://doi.org/10.1136/bmjopen-2017-020432

Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda. / Murenzi, Gad; Dusingize, Jean Claude; Rurangwa, Theogene; Sinayobye, Jean D.Amour; Munyaneza, Athanase; Murangwa, Anthere; Zawadi, Thierry; Hebert, Tiffany M.; Mugenzi, Pacifique; Adedimeji, Adebola A.; Mutesa, Leon; Anastos, Kathryn; Castle, Philip E.

In: BMJ Open, Vol. 8, No. 8, e020432, 01.08.2018.

Research output: Contribution to journalArticle

Murenzi, G, Dusingize, JC, Rurangwa, T, Sinayobye, JDA, Munyaneza, A, Murangwa, A, Zawadi, T, Hebert, TM, Mugenzi, P, Adedimeji, AA, Mutesa, L, Anastos, K & Castle, PE 2018, 'Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda', BMJ Open, vol. 8, no. 8, e020432. https://doi.org/10.1136/bmjopen-2017-020432
Murenzi G, Dusingize JC, Rurangwa T, Sinayobye JDA, Munyaneza A, Murangwa A et al. Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda. BMJ Open. 2018 Aug 1;8(8). e020432. https://doi.org/10.1136/bmjopen-2017-020432
Murenzi, Gad ; Dusingize, Jean Claude ; Rurangwa, Theogene ; Sinayobye, Jean D.Amour ; Munyaneza, Athanase ; Murangwa, Anthere ; Zawadi, Thierry ; Hebert, Tiffany M. ; Mugenzi, Pacifique ; Adedimeji, Adebola A. ; Mutesa, Leon ; Anastos, Kathryn ; Castle, Philip E. / Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda. In: BMJ Open. 2018 ; Vol. 8, No. 8.
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