Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
研究概览
简要总结
The goal of this pragmatic randomized control trial is to evaluate the effectiveness of three interventions in improving follow-up adherence among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. The interventions include structured nurse-led telephone call reminders, home-visit reminders led by health extension workers, and application-based automated SMS text reminders. The main questions it aims to answer are:
- Does structured nurse-led telephone call reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?
- Does home-reminder visits led by a Health Extension Worker (HEW) improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?
- Does app-based automated SMS reminders improve follow-up adherence among women treated for suspicious cervical lesions compared to standard care?
Structured Nurse-Led Telephone Call Reminders
- Participants will receive proactive phone call reminders for scheduled follow-up visits.
- The intervention includes three rounds: initially at 4 months post-recruitment, then every 4 months for HIV-negative women over a year, and every 2 months for 6 months for women living with HIV.
Home-Reminder Visits Led by HEW Health Extension Workers (HEWs) will conduct door-to-door visits to remind participants of their scheduled follow-up appointments.
• Door-to-door Visits will occur initially at 4 months (for HIV-negative women) and 2 months (for HIV-positive women) post-recruitment, then every 2 months for 6 months for HIV-positive and every 4 months for 12 months for HIV-negative participants.
App-Based Automated SMS Reminders
- Participants will receive SMS-based reminders for their follow-up visits.
- The intervention consists of three rounds: initial texts at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively, followed by reminders every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.
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
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 30-49 (HIV-negative).
- •Women over 25 (HIV-positive).
- •Treated for suspicious cervical lesions after a positive VIA screening.
排除标准
- •History of hysterectomy.
- •Diagnosis of other histological invasive cervical cancer.
- •Suspicious cervical cancer cases.
- •Pregnancy.
- •Prior screening history.
- •Vaginal bleeding.
- •Lack of consent.
结局指标
主要结局
Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
时间窗: re-screening (VIA) after one year (11-13 months)
Follow up adherence will be measured re-screening (VIA) after one year (11-13 months after first screening). We will use objective measurement thorough review of the comprehensive records maintained within the cervical cancer screening follow-up registry.Accordingly, women who fail to return for their scheduled follow-up visit will be categorized as "Lost to Follow-Up", while those who do attend will be categorized as "Follow-Up Adherent
次要结局
未报告次要终点
研究者
Alemnew Destaw Mezgebu
Mr
Addis Ababa University