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Abstract
Introduction Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a—customised text message invitation; step 1b—customised automated phone call invitation; step 2—secretary phone call; step 3—family health professional phone call and face-to-face appointment.
Methods A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses.
Ethics and dissemination The study was approved by the Ethics Committee of the Northern Health Region Administration and National Data Protection Committee. Results will be disseminated through communications in scientific meetings and peer-reviewed journals.
Trial number NCT03122275
- mass screening
- early detection of cancer
- uterine cervical neoplasms
- text messaging
- reminder systems
- directive counselling
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Contributors All the authors of the manuscript follow the four criteria of authorship defined by ICMJE. A description of responsabilities/author can be found below: JãF-M. Protocol responsibilities: conceptual design of the research project, drafted the first version of the protocol manuscript and final manuscript production. Study implementation responsibilities: responsible for study presentation and enrolment of all primary care units, intervention implementation, data collection and analysis and manuscript writing. RM. Protocol responsibilities: conceptual design of the research project and critical review of the manuscript. Study implementation responsibilities: responsible for study presentation and enrolment of the primary care units from ACeS Marão e Douro Norte, intervention implementation and data collection. AéM. Protocol responsibilities: conceptual design of the research project and critical review of all protocol drafts. Study implementation responsibilities: responsible for study presentation and enrolment of the primary care units from ACeS Porto Oriental, intervention implementation. NL. Protocol responsibilities: conceptual design of the research project and critical review of all versions of the manuscript. Study implementation responsibilities: responsible for the supervision of the study implementation, data collection and analysis and writing of the manuscripts. All the authors gave a final approval of the version to be published and agreed to be accountable for all aspects of the work.
Funding This work is supported by the groups of primary healthcare units involved in the study (ACeS Porto Ocidental and Marão e Douro Norte) and the Instituto de Saúde Pública da Universidade do Porto (ISPUP). The groups of primary care units contribute with the human resources involved in the field work and data collection. The cost of text messages and phone calls are supported by ACeS Porto Ocidental and ISPUP.
Competing interests None declared.
Ethics approval Comissão de Ética da Administração Regional de Saúde do Norte (number 20/2017) and Portuguese National Data Protection Committee (number 11467/2016).
Provenance and peer review Not commissioned; externally peer reviewed.