Point-of-care HPV testing for the evaluation of cervical cancer risk in Thyolo, Malawi,

Twabi, Hussein

Point-of-care HPV testing for the evaluation of cervical cancer risk in Thyolo, Malawi,

Date

2022-03-16

Authors

Twabi, Hussein

Publisher

Kamuzu University of Health Sciences

Abstract

The type of research study We will conduct a prospective cohort study for a diagnostic evaluation at Thyolo District Hospital outpatient gynaecological unit. The problem to be studied Cervical cancer is the leading cause of cancer-related death in low- and middle-income countries. Malawi has the world’s highest incidence and mortality rates due to cervical cancer. This is despite cervical cancer being one of the most preventable and treatable malignant conditions worldwide. Human papilloma virus (HPV) testing has been found to be more effective in screening for cervical cancer than conventional and liquid-based cytology. The emergence of point-of-care (POC) HPV tests have made it possible to implement HPV testing in low-resource settings, and this may be the best strategy for cervical cancer screening in such settings. The Research objectives Broad objective Determine a baseline screen strategy utilising point-of-care HPV testing in patients presenting for routine cervical cancer screening. Specific objectives • To determine the sensitivity, specificity, positive and negative predictive value of POC HPV testing for prevalent and incident high-risk HPV serotypes in participants presenting for cervical cancer screening. • To determine the predictive value of POC HPV testing for cervical abnormalities identified on VIA screening. • To describe the spatial distribution of HPV-positive and VIA-positive individuals in the community. Methodology We will conduct a survey of the cervical cancer screening registers at Thyolo District Hospital. We will then conduct a prospective cohort study of diagnostic accuracy. Participants will be 300 female adults presenting for routine cervical cancer screening at Thyolo District Hospital. Following consent, they will undergo sterile speculum examination wherein cervical cytobrush samples for Cepheid Xpert® HPV point-of-care test and Cervical cytobrush sample for real-time (RT) reverse transcriptase polymerase chain reaction (PCR) will be taken. Visual Inspection with acetic acid (VIA) will then be conducted. Clinic staff will be provided with the results of the VIA and RT-PCR to inform patient management. Participants will return at 3 weeks and 6 weeks for reassessment, with no further assessments planned. The primary outcome will be prevalence of HR-HPV serotypes identified by the tests.Expected findings and their dissemination. We hypothesize that there is a high burden of HR-HPV serotypes in women attending cervical cancer screening. Additionally, we expect the POC HPV test to have high sensitivity and specificity in identifying HR-HPV positive individuals. The results of this study will be submitted to College of Medicine Research and Ethics Committee (COMREC) and to journals for peer-reviewed publication, as well as the Thyolo District Hospital and the Queen Elizabeth Central Hospital to inform clinical approaches to cervical cancer screening. The results of the study will also be shared with policy makers at the Ministry of Health in Malawi and the World Health Organization (WHO).