Dataset Information

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.

ABSTRACT:

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.

SUBMITTER: Taghavi K

PROVIDER: S-EPMC7751198 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.

Taghavi Katayoun K Moono Misinzo M Mwanahamuntu Mulindi M Basu Partha P Limacher Andreas A Tembo Taniya T Kapesa Herbert H Hamusonde Kalongo K Asangbeh Serra S Sznitman Raphael R Low Nicola N Manasyan Albert A Bohlius Julia J

BMJ open 20201218 12

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>We ...[more]

PMID: 33371015

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Project description:IntroductionPrecancerous lesions of the cervix are changes in cervical cells that make them more likely to develop into cancer. Understanding the prevalence and determinants of the precancerous lesions of the cervix among women helps to take an action like vaccination programs, improving screening coverage, and close management and follow-up which could decrease the morbidity and mortality caused by cervical cancer.Materials and methodsThe international databases, PubMed/MEDLINE, Web of Science, EMBASE, CINAHL, Google Scholar, Science Direct and Cochrane Library and unpublished reports were systematically searched. Two authors independently extracted all necessary data using a standardized data extraction format. STATA 14 statistical software was employed to analyse the data. The Cochrane Q test statistics and I2 tests were used to assess the heterogeneity between the studies. A random-effect model was computed to estimate the pooled prevalence of precancerous lesions of the cervix in Ethiopia. Determinants of the precancerous lesion of cervix (early initiation of sexual intercourse, multiple sexual partners, and history of sexually transmitted infection) were analysed.ResultsThirteen studies fulfilled the inclusion criteria and included in the meta-analysis. The I2 test result showed high heterogeneity (I2, 93.2%, p = <0.001). Using the random effect analysis, the pooled prevalence of precancerous lesions of the cervix among women in Ethiopia was 14.21% (95% CI (10.49, 17.94). After adjusting of publication bias using trim-and-fill method, the pooled prevalence was 9.43% (95% CI (5.23, 13.62). Women who had multiple sexual partners in their lifetime (OR:2.67 CI: 1.49,4.79) and had a history of sexually transmitted infections (OR:6.22 CI: 2.99,12.92) were more likely to have a precancerous lesion of the cervix.ConclusionThe pooled prevalence of the precancerous lesions of the cervix among Ethiopian women was 9.43%. It was associated with having multiple sexual partners and a history of sexually transmitted infections.

Project description:BackgroundAlthough the human papillomavirus (HPV) vaccine has been recommended in Germany for girls since 2007, no organised vaccination programme was introduced and HPV vaccine coverage remains low. We investigated the HPV vaccination rates from 2008 to 2018 and the effects of HPV vaccination on anogenital warts and precancerous lesions in young women in Bavaria, Germany, a state with low vaccination rates.MethodsRetrospective analyses of claims data from the Bavarian Association of Statutory Health Insurance Physicians (KVB) on females born between 1990 and 2009 (9 to 28 years old in 2018) were conducted to calculate vaccination rates by birth cohort, proportion of vaccine types administered and incidence of anogenital warts and precancerous lesions of the cervix uteri. 942 841 Bavarian females 9 to 28 years old with available information on HPV vaccination were included to calculate vaccination rates. For the outcome analyses, data from 433 346 females 19 to 28 years old were analysed. Hazard ratios (HR) were computed from univariable and multivariable Cox regression models comparing vaccinated and unvaccinated women, considering type of vaccine used and contraceptive prescription.Results40·9% of 18-year-olds and only 13·3% of 12-year-olds were fully vaccinated in 2018 in Bavaria. Gardasil® and Gardasil9® were most commonly administered. Vaccinated compared to unvaccinated women had a lower incidence of anogenital warts and cervical lesions, however only small differences were detected between fully and partially vaccinated women. Fully vaccinated women had a 63% (HR 0·37 (95% confidence interval (CI) 0·34 to 0·40) and 23% (HR 0·77, 95%CI 0·71 to 0·84) lower risk of anogenital warts and cervical lesions, respectively. Women who were prescribed contraceptives prior to vaccination had a 49% higher risk of developing anogenital warts (HR 1·49, 95%CI 1·25 to 1·79) or cervical lesions (HR 1·49, 95%CI 1·27 to 1·75) compared to vaccinated women without contraceptive prescription.ConclusionsThe evaluation of the effects of HPV vaccination in Bavaria showed a promising decline of anogenital warts and precancerous lesions in vaccinated young women. However, an increase in vaccination rates is necessary to achieve a greater population impact in preventing HPV-related diseases.

Dataset Information

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.

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