Hpv Detection in Urine and Cervical Samples and Cytological Profile of Women With Hiv in Kenyatta National Hospital- a Comparative Cross-sectional Study

Abstract

Background: Human immunodeficiency virus (HIV)–positive women are at higher risk of Human Papillomavirus (HPV) acquisition. While urine-based HPV testing could improve poor cervical cancer participant screening rates and circumvent the need for an annual Papanicolaou test (Pap test) for HPV negative women, it has not been studied to date in Kenya. Objective: To compare the rate of detection of HPV in urine and cervical samples in HIV-positive women. Design and Setting: A cross-sectional comparative study where HPV DNA was tested in a paired urine sample and cervical samples of women at the Comprehensive Care Centre between September 2019 and November 2019 at the Kenyatta National Hospital, Nairobi–Kenya. Materials and methods: Roche Cobas 4800 Assay was used for testing 71 paired cervical and urine samples respectively for HPV DNA. The levels of agreement of the paired samples were assessed using kappa coefficient (k), with a 95% confidence interval (CI). The probability values (p-values) from McNemar’s test were used for significance test. A multivariable Poisson regression model with a robust variance estimator was used to model the correlates of risks. Results: HIV-positive women of mean age of 44.28±10.6 years were studied. The prevalence of HPV was 68% (95% CI: 55%–78%) in cervical samples and 35.2% (95% CI: 24% - 47%) in urine samples. The level of agreement between urine and cervical samples for any HPV was substantial (% agreement=84.5%, k= 0.69, 95% CI=0.5146–0.8563), fair for any HR HPV (% agreement = 67.6%, k=0.41, 95% CI=0.2160–0.6104, substantial agreement for HPV 16 and/or HPV 18 (% agreement=93.0%, k=0.70, 95% CI=0.4454–0.9534), and fair agreement (k=0.39, CI 95%=0.1922–0.5889) for other HR HPV (Non HPV 16/18). The McNemar’s test and Chi-square tests showed that the performance of the urine and cervical samples were not equal (p-values <0.05). Sensitivity of urine for any HPV detection was high at 77% (95% CI=63% – 88%), while specificity was 100% (85%–1.00%). The pap smears were mostly negative for intraepithelial lesion or malignancy (NILM) (91.5%). Being married (monogamous) was associated with HR HPV prevalence that was 41% (adjusted Prevalence Ratio 0.59, 95% CI: 0.36–0.99) lower than those of divorced/separated women (p<0.05). Conclusion: The detection rate in urine sample was a little lower than in cervical samples. These findings demonstrate that urine-based HPV test can be employed not as a single test as cervical sample test and certainly not as an alternative method but as a cotest with possible improvements of sample collection and processing.