Table 3 Endpoints
| Â | Endpoint |
|---|---|
HPV prevalence & persistence | Proportion of participants with documented HR-HPV, LR-HPV and HPV negative at baseline |
HPV genotypes at baseline | |
Proportion of participants with documented HR-HPV, LR-HPV and HPV negative at follow up (6Â months after the first sample) | |
HPV genotypes at follow up (6Â months after the first sample) | |
Rate of clearance and persistence of HPV at 6Â months follow-up and factors associated with viral persistence | |
Cervical lesions | Prevalence of cervical dysplasia among the patients with HR-HPV |
Prevalence of co-infection (STI and GS) | |
QG-MPH® performance | Prevalence of HSIL/CC detected by QG-MPH® in cervical smear samples |
Diagnostic test accuracy (sensitivity, specificity, PPV, NPV) in detecting patients with CIN3 + compared to colposcopy images, HPV infection detected by Seegene Anyplex ™ II 28 and histology | |
Prevo-check® performance | Prevalence of HPV16 positive CIN2 + detected by Prevo-check® |
Diagnostic test accuracy (sensitivity, specificity, PPV, NPV) in detecting patients with HPV 16 compared to Seegene Anyplex â„¢ II 28 | |
PT Monitor® performance | Comparison of HPV16-antibody levels in women with and without HPV16-positive CIN2 + . Calculation of test performance parameters (sensitivity, specificity, PPV, NPV) at different antibody thresholds and calculation of optimum cut-off for CIN2 + detection by ROC analysis and Youden index |
Diagnostic test accuracies (sensitivity, specificity, PPV, NPV) in detecting patients with HPV16-induced CIN2 + by PT Monitor® compared to colposcopy images, HPV infection detected by Seegene Anyplex ™ II HPV 28 Detection and histology | |
Screening strategy implementation | Acceptability of cervical self-sampling |
Acceptability of proposed implemented pathway | |
Adherence to follow-up | |
Rate of WLWH completing the CC screening and treatment care plan | |
Prevalence of cryo/thermoablation-non-eligible lesions treated with LEEP | |
Service accessibility (means of travel to the point of screening: foot, car bajaj, public transport bus; distance to hospital < 5 km, 5—10 km, > 10 km, perceived difficulty of travel yes/no; mean of waiting time in minutes at point of screening) | |
Social and educational status of WLWH attending and refusing CC screening as well as their awareness regarding HPV infection, transmission, risk behavior, CC | |
Costs | Direct and indirect costs associated with CC screening and treatment before and after the proposed implementation was adopted including the bundle of interventions |
Direct and indirect costs, as well visit durations, for the current VIA and cryotherapy standard of care and for the implemented path with HPV-based triage |