RANDOMIZED CONTROLLED TRIAL OF THE USE OF TEXT MESSAGE REMINDERS TO INCREASE PNEUMOCOCCAL VACCINATION COVERAGE IN ADULTS AGED 65 YEARS IN CHILE.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43,000
- 试验地点
- 1
- 主要终点
- Pneumococcal vaccination coverage at day 42
研究概览
简要总结
The goal of this randomized controlled trial is to learn if text message reminders sent through WhatsApp increase pneumococcal vaccination coverage in adults turning 65 years old in Chile. The main questions it aims to answer are:
Do text message reminders increase the proportion of adults aged 65 years who receive the pneumococcal vaccine compared to usual care? Do text message reminders increase pneumococcal vaccination coverage within the first 7 days after the message is sent? Is there an association between socioeconomic factors and pneumococcal vaccination coverage in adults aged 65 years in Chile?
Researchers will compare adults who receive a text message reminder to adults who receive no reminder (usual care) to see if the reminders increase vaccination uptake.
Participants will:
Be randomly assigned to receive a WhatsApp text message reminder about the pneumococcal vaccine or to receive no reminder Receive a second reminder on day 14 if they have not yet been vaccinated (intervention group only) Be followed for 6 weeks, with vaccination status checked at days 7, 21, and 42 from the start of the intervention
详细描述
Background and Rationale Streptococcus pneumoniae is a globally distributed pathogen responsible for a wide spectrum of diseases, with the highest burden concentrated in children under 5 years and adults over 50 years. In Chile, invasive pneumococcal disease represents a growing public health threat among older adults: between epidemiological weeks 1 and 30 of 2024, reported cases increased by 9% compared to the previous year, with adults aged 60 years and older accounting for 47.7% of all registered isolates.
Despite the availability of the 23-valent pneumococcal polysaccharide vaccine (PPV23) free of charge through Chile's National Immunization Program (Programa Nacional de Inmunizaciones, PNI) since 2007, vaccination coverage among adults turning 65 years has remained consistently insufficient. The cohort born in 1957 reached 25.6% coverage in 2022; the 1958 cohort reached 25.0% in 2023; and the 1959 cohort reached 30.1% in 2024. These figures fall well below established public health targets and reflect a structural gap that conventional communication strategies have failed to close.
Text message reminders have emerged as a promising intervention to improve vaccination coverage. They are low-cost, scalable, rapidly deployable, and applicable at the population level. The most recent systematic review and meta-analysis of randomized controlled trials on this topic demonstrated that text message reminders significantly increase vaccination coverage by 9% (95% CI: 6-13%), an effect that is consistent regardless of message content, country income level, or target population age. Chile offers particularly favorable conditions for this type of intervention, with over 30 million active mobile phones, 94.1% internet access, and 75% social media users, positioning it as one of the most digitally connected countries in Latin America.
Study Design Is an open-label, parallel-group, randomized controlled trial conducted within the operational framework of Chile's National Immunization Program. Adults born in 1961 who turn 65 years of age in 2026, have a valid mobile phone number registered in the National Immunization Registry (Registro Nacional de Inmunizaciones, RNI), and have no prior record of pneumococcal vaccination will be eligible for inclusion. Individuals identified as deceased in the RNI will be excluded.
From an estimated base cohort of 175,000 adults born in 1961, approximately 43,000 individuals are expected to meet the eligibility criteria and constitute the study population. All eligible individuals will be included by convenience sampling, with no additional active selection process. Participants will be randomized 1:1 to the intervention or control group using stratified randomization by sex and region of Chile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 64 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults born during the year 1961, turning 65 years of age in 2026
- •Resident in Chile at the time of the study
- •Valid mobile phone number registered in the National Immunization Registry (RNI)
排除标准
- •Record of pneumococcal vaccination in the National Immunization Registry (RNI).
- •Identified as deceased in the Chilean Civil Registry and Identification Service.
研究组 & 干预措施
Text message reminder group
Participants assigned to this arm will receive a WhatsApp text message reminder on day 0 of the intervention, sent by the Ministry of Health of Chile through the official National Immunization Program contactability platform (EMILIA, Rayén Salud). The message will include an acknowledgment that the participant is eligible for free pneumococcal vaccination upon turning 65 years of age, confirmation that the vaccine is available at no cost, and the name, address, and operating hours of vaccination centers in the participant's municipality of residence. A second reminder message will be sent on day 14 to participants who have not yet been vaccinated. Participants will be followed for 6 weeks, with vaccination status assessed at days 7, 21, and 42 from the start of the intervention.
干预措施: WhatsApp text message reminder for pneumococcal vaccination (Behavioral)
Usual care group
Participants assigned to this arm will not receive a text message reminder. They will be informed of the pneumococcal vaccination recommendation through the usual communication channels of the National Immunization Program, including written press, digital media, and official social media accounts of the Ministry of Health of Chile. Vaccination status will be assessed at days 7, 21, and 42 from the start of the intervention, using the National Immunization Registry (RNI) as the data source.
结局指标
主要结局
Pneumococcal vaccination coverage at day 42
时间窗: 42 days from the start of the intervention
Proportion of randomized adults in each group who received the 23-valent pneumococcal polysaccharide vaccine (PPV23) within 42 days from the start of the intervention. Vaccination status will be ascertained through the National Immunization Registry (RNI). Coverage will be calculated as the number of vaccinated adults divided by the total number of randomized adults in each group. The association between the intervention and the outcome will be assessed using a chi-square test, and the magnitude of the association will be expressed as relative risk with 95% confidence intervals.
次要结局
- Pneumococcal vaccination coverage at day 7(7 days from the start of the intervention)
- Pneumococcal vaccination coverage at day 21(21 days from the start of the intervention)
- Time to pneumococcal vaccination(42 days from the start of the intervention)
- Association between sociodemographic factors and pneumococcal vaccination coverage(42 days from the start of the intervention)
研究者
Pablo Tomás Valenzuela García
Specialist in Adult Infectious Diseases and Epidemiologist, UC. Advisor to the National Immunization Program, Ministry of Health, Chile.
Pontificia Universidad Catolica de Chile
