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Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol
INTRODUCTION: The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We wil...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751198/ https://www.ncbi.nlm.nih.gov/pubmed/33371015 http://dx.doi.org/10.1136/bmjopen-2020-037955 |
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author | Taghavi, Katayoun Moono, Misinzo Mwanahamuntu, Mulindi Basu, Partha Limacher, Andreas Tembo, Taniya Kapesa, Herbert Hamusonde, Kalongo Asangbeh, Serra Sznitman, Raphael Low, Nicola Manasyan, Albert Bohlius, Julia |
author_facet | Taghavi, Katayoun Moono, Misinzo Mwanahamuntu, Mulindi Basu, Partha Limacher, Andreas Tembo, Taniya Kapesa, Herbert Hamusonde, Kalongo Asangbeh, Serra Sznitman, Raphael Low, Nicola Manasyan, Albert Bohlius, Julia |
author_sort | Taghavi, Katayoun |
collection | PubMed |
description | INTRODUCTION: The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa. METHODS AND ANALYSIS: We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03931083; Pre-results. |
format | Online Article Text |
id | pubmed-7751198 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-77511982020-12-29 Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol Taghavi, Katayoun Moono, Misinzo Mwanahamuntu, Mulindi Basu, Partha Limacher, Andreas Tembo, Taniya Kapesa, Herbert Hamusonde, Kalongo Asangbeh, Serra Sznitman, Raphael Low, Nicola Manasyan, Albert Bohlius, Julia BMJ Open HIV/AIDS INTRODUCTION: The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa. METHODS AND ANALYSIS: We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03931083; Pre-results. BMJ Publishing Group 2020-12-18 /pmc/articles/PMC7751198/ /pubmed/33371015 http://dx.doi.org/10.1136/bmjopen-2020-037955 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ 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/. |
spellingShingle | HIV/AIDS Taghavi, Katayoun Moono, Misinzo Mwanahamuntu, Mulindi Basu, Partha Limacher, Andreas Tembo, Taniya Kapesa, Herbert Hamusonde, Kalongo Asangbeh, Serra Sznitman, Raphael Low, Nicola Manasyan, Albert Bohlius, Julia Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title | Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title_full | Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title_fullStr | Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title_full_unstemmed | Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title_short | Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol |
title_sort | screening test accuracy to improve detection of precancerous lesions of the cervix in women living with hiv: a study protocol |
topic | HIV/AIDS |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751198/ https://www.ncbi.nlm.nih.gov/pubmed/33371015 http://dx.doi.org/10.1136/bmjopen-2020-037955 |
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