Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 705
- 试验地点
- 3
- 主要终点
- Effect of SMS intervention on attendance rate to follow-up screening appointment
研究概览
简要总结
This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.
详细描述
Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •HPV positive
- •Age 25 - 60 years
- •Private mobile phone
排除标准
- •Pregnant on day of enrolment
- •Menstruating on day of enrolment
- •Hysterectomy
- •Diagnosed with cervical pre-cancer within past 12 months
- •Diagnosed with cervical cancer
- •Invalid mobile phone number
- •Unreachable when trying to convey HPV positive result
研究组 & 干预措施
Connected to Care
The SMS intervention will consist of 15 text messages that will be sent to the intervention group over a period of 10 months. There will be two types of text messages: (1) educational text messages; and (2) SMS reminders for the follow-up appointment.
干预措施: Connected to Care (Behavioral)
Control
The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.
结局指标
主要结局
Effect of SMS intervention on attendance rate to follow-up screening appointment
时间窗: up to 14 months
The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group.
次要结局
- Acceptability of text message intervention(2 years)
- Acceptability of text message intervention(Baseline + 2 years Follow-up (likert scale))
研究者
Marianne Andersen
Clinical professor
Odense University Hospital