PRIORITY Study in Cervical Cancer

Sensitivity, specificity, positive predictive value, and negative predictive value of the combined strategy including extended molecular self-sampling, clinician-collected sampling, and digital colposcopy for detecting histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

Measure reported: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Agreement between vaginal self-sampling and clinician-collected cervical samples for detection of high-risk HPV genotypes and extended molecular findings, assessed using Cohen's kappa and percent agreement.

Measure reported: Cohen's kappa coefficient and percent agreement.

Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected through the extended molecular panel, including Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, bacterial vaginosis-associated markers, Candida species, and genital ulcer pathogens.

Measure reported:

Prevalence (%) of sexually transmitted infections and vaginal dysbiosis markers detected through extended molecular screening.

Prevalence ratio of high-risk HPV positivity among participants with sexually transmitted infections detected using the extended molecular screening panel. High-risk HPV positivity will be defined as the proportion (%) of participants with a positive validated molecular HPV test.

Measure reported: Prevalence ratio (PR) with 95% confidence intervals.

Odds ratio for histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) among participants with sexually transmitted infections detected using the extended molecular screening panel. CIN2+ will be defined as the proportion (%) of participants with histologically confirmed cervical intraepithelial neoplasia grade 2 or worse.

Measure reported: Odds ratio (OR) with 95% confidence intervals.

Time from initial molecular self-sampling to diagnostic resolution, defined as histological confirmation when clinically indicated or completion of diagnostic evaluation according to standard care.

Measure reported: days from initial molecular self-sampling to diagnostic resolution.

Participant-reported acceptability will be assessed using the investigator-developed Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire, a structured 5-item questionnaire evaluating ease of self-sampling, confidence in performing the procedure, understanding of instructions, comfort with digital colposcopy, and satisfaction with telemedicine-supported follow-up. Each item is scored on a 5-point Likert scale from 1 to 5. A composite score will be calculated by summing all item responses. Scores range from 5 to 25 points, with higher scores indicating greater acceptability.

Measure reported: Composite acceptability score (range 5-25 points; higher scores indicate greater acceptability).

Participant-reported transportation expenses associated with screening, diagnostic evaluation, referral visits, and follow-up care will be assessed using an investigator-developed healthcare utilization and cost questionnaire. Total transportation costs will be calculated as the cumulative sum of all transportation-related expenses incurred throughout the diagnostic pathway.

Measure reported: Total transportation cost in Chilean pesos (CLP).

Number of participant-reported productive activity days lost throughout the diagnostic pathway, assessed as a single cumulative count variable.

Measure reported: Total number of productive activity days lost.

Participant-reported indirect non-medical expenses incurred during the diagnostic process will be assessed using an investigator-developed healthcare utilization and cost questionnaire. Total indirect non-medical expenses will be calculated as the cumulative sum of eligible participant-reported expenses.

Measure reported: Total indirect non-medical expenses in Chilean pesos (CLP).