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 (2020). Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol. BMJ open, 10(12), e037955. BMJ Publishing Group 10.1136/bmjopen-2020-037955

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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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

Graduate School:

Graduate School for Cellular and Biomedical Sciences (GCB)

UniBE Contributor:

Taghavi, Katayoun, Limacher, Andreas, Asangbeh, Serra Lem, Low, Nicola, Bohlius, Julia Friederike

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2044-6055

Publisher:

BMJ Publishing Group

Funders:

[189] Swiss Cancer Research = Krebsforschung Schweiz ; [190] ESTHER Switzerland

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

05 Jan 2021 15:14

Last Modified:

20 Feb 2024 14:16

Publisher DOI:

10.1136/bmjopen-2020-037955

PubMed ID:

33371015

Uncontrolled Keywords:

HIV & AIDS epidemiology gynaecology public health

BORIS DOI:

10.48350/150738

URI:

https://boris.unibe.ch/id/eprint/150738

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