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.
- human papillomavirus (hpv)
- cervical cancer
- cervical intraepithelial neoplasia
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Contributors KA, PEC, JCD, AA and JDS conceived the original concept of the study and the interventions. GM, KA and PEC drafted the protocol. PEC performed the sample size calculations, and PEC and GM will lead analysis of the results. GM, JDS and AM are supporting patient recruitment. GM, TR and AM are providing clinical care for patients. AM and LM oversee laboratory testing, and TZ and TH are responsible for pathology. GM and LM oversee and administer the study activities at the clinical site in Rwanda. All authors contributed to the scientific design of the study and the protocol development, are involved in the implementation of the project and have read and approved the final manuscript.
Funding This study was funded by NCI/NIH Grant 5U54CA19016304 and by a grant from the Prevent Cancer Foundation.
Competing interests This research study has received HPV tests for reduced or no cost from Cepheid, Arbor Vita Corporation, and Roche.
Patient consent Obtained.
Ethics approval Institutional Review Board for human subjects research at Albert Einstein College of Medicine and Rwanda National Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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