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Effect of an intelligent digital education tool on the accurate diagnosis of patients referred for colposcopy in medically underserved areas in China: a stepped-wedge cluster randomized trial

Effect of an intelligent digital education tool on the quality of colposcopy examinations: a stepped-wedge cluster randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101193
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

intervention period:Using the Colposcopy Training Platform (iDECO)
control period:do not receive iDECO-based training

Sponsors

School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1.Group Level This study will include nine maternal and child health hospitals that perform colposcopy, consisting of six county-level maternal and child health hospitals in rural areas and three district-level maternal and child health hospitals in urban areas. The inclusion criteria are as follows: (1) The hospital is responsible for local cervical cancer screening and has the capability to perform colposcopy; (2) No other colposcopy training programs are planned during the study period; (3) Willingness to participate in this study. 2.Individual Level Inclusion criteria for individual participants: Women aged 35–64 who have not undergone cervical cancer screening in the past three years during the study period; Women referred for colposcopy due to abnormal cervical cancer screening results, specifically for any of the following reasons: Positive HPV test: Positive for HPV16 or HPV18, or persistent infection with other high-risk HPV subtypes; Abnormal cytology results: Cytology results showing abnormalities greater than atypical squamous cells of undetermined significance (ASC-US), or ASC-US with a positive HPV triage test; Positive visual inspection with acetic acid/Lugol’s iodine (VIA/VILI); Willingness to participate in the study.

Exclusion criteria

Exclusion criteria: Individual-Level Exclusion Criteria: Women with a history of cervical cancer or precancerous lesions; Women with a history of treatment for cervical cancer or precancerous lesions; Pregnant women.

Design outcomes

Primary

MeasureTime frame
colposcopy diagnostic accuracy;

Secondary

MeasureTime frame
The standardization rate of colposcopy reports;Trainee’s test score on the iDECO platform;Trainee satisfaction with the iDECO training;

Countries

China

Contacts

Public ContactYoulin Qiao

Chinese Academy of Medical Sciences and Peking Union Medical College

qiaoy@cicams.ac.cn+86 139 1041 0711

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026