An interventional study of Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders. in Suspicious Cervical Cancer Lesions Follow up Adherence, sponsored by Addis Ababa University. Recruiting at 1 site in Ethiopia. Open to female participants aged 25 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Addis Ababa University · Not applicable, Interventional, and Prevention
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:
Structured Nurse-Led Telephone Call Reminders
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.
App-Based Automated SMS Reminders
Exclusion Criteria:
Participants in this arm will receive proactive telephone call reminders from nurses for their scheduled follow-up visits. Reminders will be administered initially at 4 months post-recruitment and then every 4 months for a year for HIV-negative women. For women living with HIV, reminders will be administered every 2 months for 6 months after recruitment.
Behavioral: Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders.
Health Extension Workers (HEWs) will conduct home visits to remind participants of their scheduled follow-up appointments. Scheduled initially at 4 months post-recruitment for HIV-negative women and 2 months for HIV-positive women, followed by visits every 2 months for 6 months for HIV-positive individuals and every 4 months for 12 months for HIV-negative individuals.
Behavioral: Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders.
Participants will receive automated SMS text reminders via a mobile application for their follow-up visits. SMS reminders will be sent initially at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively. Subsequent reminders will be sent every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.
Behavioral: Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders.
Participants in the control group will receive standard follow-up care according to the guidelines outlined by the Ethiopian Ministry of Health and current clinical practices of the country.These women will be orally informed of their follow-up appointment dates and will receive a post-treatment follow-up card at the baseline. Apart from this information and routine care, no additional interventions will be provided.
Behavioral: Intervention 1: Structured nurse-led telephone call reminders. Intervention 2: Home-visit reminders by health extension workers. Intervention 3: Application-based automated SMS text reminders.
Information already available
Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
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
Time frame: re-screening (VIA) after one year (11-13 months)
Plan to share: No — Individual participant data (IPD) will not be shared to maintain participant confidentiality and comply with ethical guidelines. However, aggregated, de-identified data will be made available upon reasonable request after study completion and publication. Requests should be directed to the corresponding author, and data access will be provided in line with institutional policies and BMJ Open's data-sharing policy requirements.
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Addis Ababa University