Digital health interventions for cervical cancer screening among hard-to-reach women in health-resource-limited areas: Protocol for a controlled trial with historical controls and two randomised intervention arms

针对医疗资源匮乏地区难以触及的女性开展宫颈癌筛查的数字化健康干预:一项包含历史对照和两个随机干预组的对照试验方案

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Abstract

BACKGROUND: Cervical cancer remains a leading cause of cancer morbidity and mortality among women worldwide, with an estimated 661,021 new cases and 348,189 deaths in 2022. In China's health-resource-limited areas, a substantial share of the population remains hard to reach, and the effectiveness of data-driven identification and digital outreach for this hard-to-reach population is uncertain. OBJECTIVE: This study aims to (a) use ID-card-based record linkage to identify women who have never undergone cervical cancer screening and (b) evaluate whether the integrated digital intervention reduces redundant repeat screening while improving women's knowledge, attitudes and practices (KAP) in health-resource-limited areas. METHODS: We will conduct a quasi-experimental controlled trial including an external historical control cohort and two individually randomised digital intervention arms in 11 sites. Women will be identified by matching unique ID-card numbers across the national screening registry and local household records. Newly screened eligible women will be randomly allocated to one of two intervention arms: (a) tailored digital interventions and (b) generic digital interventions, while an external historical cohort (January 2022-December 2023) from the same sites, before implementation of the digital platform, will serve as the control arm. RESULTS: Recruitment began on 15 April 2025. The trial plans to recruit 142,417 participants (122,817 in the historical control cohort and 9800 in each intervention arm). Baseline surveys commenced on 15 April 2025 and will continue until December 2026. CONCLUSIONS: If effective, this study will be among the first to evaluate a full-process digital health intervention that combines algorithm-based identification with a web-plus-WeChat platform for cervical-cancer screening in resource-limited areas of China. The findings could inform programme development and benefit hard-to-reach populations.

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