Evaluation of high-risk Human Papilloma Virus (hrHPV) testing in self-collected vaginal and urine samples of Human Immunodeficiency Virus (HIV) positive women for primary screening of cervical cancer in selected Anti-Retroviral Therapy (ART) centres of Belagavi district, Karnataka

Rationale: In 2023 India reported 77,348 deaths due to cervical cancer and 1,23,907 new cases. Prevalence of HPV is higher in women living with HIV(WLHIV). Primary HPV based cervical cancer screening program and self-sampling as a technique has been validated in developed countries with limited evidence in resource poor settings where majority of the disease burden lies.

Objectives: To estimate sensitivity and specificity of self-sampled hr-HPV testing (vaginal and urine) in WLHIV compared to clinician administered cervical sample for detection of cervical intra-epithelial neoplasia (CIN)2+ in a community setting. Additionally, their concordance will also be assessed. Exploration of utility of cytology, HPV and HIV viral load and CD4 counts as strategies for triage in screen positive patients.

Methods: Following training of Health Care Workers (HCWs) at ART (Antiretroviral Therapy) centres, research team will approach WLHIV. Eligible participants will be approached individually for screening and consented women will be asked to provide random FV urine samples and self-collected vaginal sample, followed by clinician-administered cervical sample collection. hr-HPV DNA detection will be done by QIAscreen HPV PCR test, which has been validated as per Meijer and VALGENT 4 panel criteria and Liquid based cytology (LBC) will be processed on the same sample by SurePathTMDirect to Slide Kit - 480 T by BDSurepath. To identify the HPV genotypes associated with high grade lesions, all colposcopy and guided biopsy specimens reported as CIN2 or CIN3 will be subjected to INNO-LiPA HPV genotyping by HPV Amp II and HPV Genotyping Extra II Kit. Management of screen positive patients will be as per Federation of Obstetrics and Gynaecologic Societies of India (FOGSI) guidelines

Expected outcome: Self-sampling technique and assay by a highly sensitive PCR based HPV test will increase test uptake rates and early detection of cervical cancer. This cervical cancer screening model can be incorporated within existing ART centres. The project will provide proof of concept for this approach. This will enable in the reduction of morbidity and mortality from cervical cancer in WLHIV