An observational study in Cervical Cancer, Cervical Intraepithelial Neoplasia and HPV Infection, sponsored by Pontificia Universidad Catolica de Chile. Not yet recruiting at 8 sites in Chile. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model combining extended molecular self-sampling and digital colposcopy supported by telemedicine for the prioritization of women at risk of cervical cancer.
The study aims to assess the diagnostic performance, concordance, and clinical utility of this integrated approach in real-world settings, as well as its impact on diagnostic timeliness and patient navigation across different levels of care.
Participants will undergo standard-of-care evaluation, and data will be collected on molecular test results, colposcopic findings, diagnostic outcomes, and time intervals within the care pathway. No interventions are assigned as part of the study protocol.
The findings are expected to inform scalable strategies to improve early detection and optimize diagnostic pathways for cervical cancer, particularly in settings with structural and geographic barriers to timely care.
The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model for cervical cancer that combines extended high-risk human papillomavirus (HPV) self-sampling, digital colposcopy, and telemedicine-based prioritization.
The study will be conducted across multiple healthcare centers in Chile, including primary care and referral centers, reflecting real-world clinical pathways. Participants will be women undergoing evaluation for cervical cancer screening or diagnostic follow-up according to standard clinical practice. No interventions are assigned as part of the study protocol.
Data will be collected prospectively and will include results from molecular HPV testing, digital colposcopic assessments, and histopathological findings when available. Additional variables will include time intervals across the diagnostic pathway, including time from screening to diagnostic confirmation, as well as healthcare system navigation indicators.
The primary objective is to assess the diagnostic performance and concordance between molecular testing and colposcopic findings. Secondary objectives include evaluation of diagnostic timeliness, feasibility of implementing the integrated model, and patient-reported experience measures.
This study is designed to generate real-world evidence on the potential of integrated diagnostic strategies to improve prioritization and reduce delays in cervical cancer detection, particularly in settings with structural and geographic barriers to timely care.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 700 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women aged 30 to 65 years participating in cervical cancer screening programs in participating centers, including both urban and underserved populations. The study aims to reflect real-world conditions, including variability in access to care, geographic barriers, and healthcare system navigation.
Exclusion Criteria:
Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+
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).
Time frame: Up to 6 months
Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection
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.
Time frame: Baseline
Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening
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.
Time frame: Baseline
Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by 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.
Time frame: Up to 6 months
Odds ratio for histologically confirmed CIN2+ in participants with sexually transmitted infections detected by extended molecular screening
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 frame: Up to 6 months
Time to diagnostic resolution
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.
Time frame: Up to 6 months
Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire
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).
Time frame: Up to 6 months
Direct transportation costs associated with the diagnostic pathway
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).
Time frame: Up to 6 months
Productive Activity Days Lost Associated With the Diagnostic Pathway
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.
Time frame: Up to 6 months
Indirect non-medical expenses associated with the diagnostic pathway
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).
Time frame: Up to 6 months
Plan to share: Yes — De-identified individual participant data (IPD) including clinical, molecular, imaging (colposcopy), and patient-reported outcomes collected during the study will be available. Data will be shared after publication of the primary results, upon reasonable request, and subject to approval by the study investigators and the corresponding ethics committee. All shared data will be fully anonymized and will not include any direct or indirect identifiers. Data access will be granted for scientifically sound proposals, with a signed data access agreement, and in compliance with Chilean data protection laws (Law 19.628) and institutional policies. No identifiable data will be shared under any circumstances.
Supporting information: Study protocol, Sap, Icf
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Pontificia Universidad Catolica de Chile