Browsing by Author "Low, Nicola"

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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, Katayoun; Moono, Misinzo; Mwanahamuntu, Mulindi; Roumet, Marie; Limacher, Andreas; Kapesa, Herbert; Madliwa, Thamsanqa; Rutjes, Anne; Basu, Partha; Low, Nicola; Manasyan, Albert; Bohlius, Julia
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.
Cervical intraepithelial neoplasia progression and regression among women living with HIV in Zambia
(2025-10-16) Andoh, John; Taghavi, Katayoun; Moono, Misinzo; Basu, Partha; Madliwa, Thamsanqa; Mwanahamuntu, Mulindi H.; Low, Nicola; Manasyan, Albert; Rohner, Eliane
Abstract Objectives: Cervical screening and precancer treatment are less effective in women living with HIV (WLWH) than in women without HIV. We assessed high-risk human papillomavirus (HR-HPV) infection and cervical disease progression among screened WLWH in Zambia. Methods: Participants underwent visual inspection with acetic acid (VIA), HR-HPV testing and cervical biopsies at baseline and at follow-up 30-36 months later. Women with positive VIA results or high-grade histology were offered treatment. We assessed HR-HPV and cervical disease prevalence at both timepoints and used multivariable logistic regression to identify factors associated with cervical disease progression and regression. Results: Among 241 included women, HR-HPV prevalence declined from 44% (95% confidence interval [CI]: 39%-49%) at baseline to 24% (95% CI: 19%-31%) at follow-up. High-grade disease decreased from 25% (95% CI: 20%-31%) to 9% (95% CI: 5%-13%). In analyses adjusted for age, CD4 cell count, HIV RNA viral load, HR-HPV infection and histological results at baseline, precancer treatment was associated with increased odds of disease regression (adjusted odds ratio [aOR]: 2.74, 95% CI: 1.08-7.06) and reduced odds of progression (aOR: 0.45, 95% CI: 0.11-1.64). One-third of women with high-grade disease at follow-up (7/21) had previously undergone precancer treatment. Conclusions: Cervical screening and precancer treatment are key to reducing cervical disease progression among WLWH and ultimately achieving cervical cancer elimination, but efforts to improve treatment effectiveness among WLWH must be balanced with the risk of overtreatment.
Genotype-specific agreement and accuracy of human papillomavirus DNA detection using AnyplexTM II HPV28 and XpertTM HPV among women with HIV in Lusaka, Zambia: a diagnostic accuracy analysis
(2026) Nathalie, Villalobos V. F; Moono, Misinzo; Andoh, John; Glass, Allison; Basu, Partha; Madliwa, Thamsanga; Mwanahamuntu, Mulindi; Rohner, Eliane; Low, Nicola; Manasyan, Albert; Taghavi, Katayoun
Abstract Objectives: The prevalence of cervicovaginal high-risk human papillomavirus (hrHPV) is high among women with human immunodeficiency virus (WHIV). Many hrHPV tests exist, but genotype-specific comparisons among WHIV are limited. We compared hrHPV detection and diagnostic accuracy using AnyplexTM II HPV 28 and XpertTM HPV among WHIV in Lusaka, Zambia. Methods: WHIV enrolled in a cervical screening test accuracy study (05/2019-03/2021) were invited for rescreening after 36 months. Trained nurses collected the cervical cytology and biopsy samples. Cytology samples were tested using Anyplex and Xpert. Women with paired and valid hrHPV results were included. We compared hrHPV and genotype-specific prevalence, overall agreement, Cohen kappa (κ), and relative sensitivity and specificity for the detection of high-grade squamous intraepithelial lesions (HSIL). Results: Among 230 women seen between 05/2022 and 06/2023, hrHPV prevalence was 24% (55/230) using Xpert and 36% (82/230) using Anyplex. Detection of HPV16 was higher with Anyplex (9%, 20/230) than with Xpert (6%, 13/230). Overall agreement was 85% (κ = 0.64; 95% confidence interval [CI] = 0.53-0.74). Genotype-specific agreement ranged from 88% (other hrHPV, κ = 0.66) to 96% (HPV16, κ = 0.70). For the detection of HSIL, the relative sensitivity of Anyplex compared with Xpert was 1.07 (95% CI = 0.94-1.21), and the relative specificity was 0.85 (95% CI = 0.79-0.91). Conclusion: Agreement between Anyplex and Xpert for hrHPV detection was high, but genotype-specific detection differed, with Anyplex detecting HPV16 more frequently than Xpert. While both assays had similar sensitivity, Xpert was more specific for HSIL. The choice of assay should balance the goals of maximizing HSIL detection with minimizing overtreatment.
Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.
(2020-Dec-18) 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
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.