Abstract
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(3)) and all except one were on antiretroviral therapy. Among 371 participants with histopathological results, 27% (101/371) women had CIN2+ and 23% (23/101) were not detected by any index test. Sensitivity and specificity for stand-alone tests were: hrHPV, 67.3% (95% CI 57.7% to 75.7%) and 65.3% (95% CI 59.4% to 70.7%); Gynocular 51.5% (95% CI 41.9% to 61.0%) and 80.0% (95% CI 74.8% to 84.3%); and VIA 22.8% (95% CI 15.7% to 31.9%) and 92.6% (95% CI 88.8% to 95.2%), respectively. Combining tests did not improve test accuracy measures. All test accuracies improved in sensitivity analysis. 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.