Browsing by Author "Low N"

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    Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.
    (2024) Taghavi K; Moono M; Mwanahamuntu M; Roumet M; Limacher A; Kapesa H; Madliwa T; Rutjes A; Basu P; Low N; Manasyan A; Bohlius J; Center for Infectious Disease Research in Zambia, Lusaka, Zambia.; Department of histopathology, Lancet Laboratories, Richmond, South Africa.; International Agency for Research on Cancer, Lyon, France.; Levy Mwanawasa Medical University Hospital, Lusaka, Zambia.; University of Basel, Basel, Switzerland.; Clinical Trials Unit, University of Bern, Bern, Switzerland.; Institute of Social and Preventative Medicine, University of Bern, Bern, Switzerland.; University of Alabama at Birmingham (UAB), Birmingham, Alabama, USA.; University of Zambia University Teaching Hospital, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    OBJECTIVE: This study aimed to provide evidence to improve cervical screening for women living with HIV (WLHIV). We assessed the accuracy of screening tests that can be used in low-resource settings and give results at the same visit. METHODS AND ANALYSIS: We conducted a paired, prospective study among consecutive eligible WLHIV, aged 18-65 years, receiving cervical cancer screening at one hospital in Lusaka, Zambia. The histopathological reference standard was multiple biopsies taken at two time points. The target condition was cervical intraepithelial neoplasia grade 2 and above (CIN2+). The index tests were high-risk human papillomavirus detection (hrHPV, Xpert HPV, Cepheid), portable colposcopy (Gynocular, Gynius) and visual inspection with acetic acid (VIA). Accuracy of stand-alone and test combinations were calculated as the point estimate with 95% CIs. A sensitivity analysis considered disease when only visible lesions were biopsied. RESULTS: Women included in the study had well-controlled HIV infection (median CD4 count=542 cells/mm CONCLUSION: The low accuracy of screening tests assessed might be explained by our reference standard, which reduced verification and misclassification biases. Better screening strategies for WLHIV in low-resource settings are urgently needed. TRIAL REGISTRATION NUMBER: NCT03931083.
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    Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.
    (2020-Dec-18) Taghavi K; Moono M; Mwanahamuntu M; Basu P; Limacher A; Tembo T; Kapesa H; Hamusonde K; Asangbeh S; Sznitman R; Low N; Manasyan A; Bohlius J; Obstetrics and Gynaecology, University Teaching Hospital, Lusaka, Zambia.; CTU Bern, University of Bern, Bern, Switzerland.; University of Alabama at Birmingham (UAB), Birmingham, Alabama, USA.; International Agency for Research on Cancer (IARC), World Health Organization, Lyon, France.; Women and Newborn health, Levy Mwanawasa Medical University Hospital, Lusaka, Zambia.; ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.; Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland katayoun.taghavi@ispm.unibe.ch.
    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.