NCT06515301

Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia

Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 466 (estimated)
• Sponsor: Addis Ababa University · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Suspicious Cervical Cancer Lesions Follow up Adherence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-11-20
• Completion: 2025-12-30
• First posted: 2024-07-23
• Last updated: 2025-06-10

Locations

1 site across 1 country: Ethiopia