Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Suspicious Cervical Cancer Lesions Follow up Adherence
- Sponsor
- Addis Ababa University
- Enrollment
- 466
- Locations
- 1
- Primary Endpoint
- Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Alemnew Destaw Mezgebu
Mr
Addis Ababa University
Eligibility Criteria
Inclusion Criteria
- •Women aged 30-49 (HIV-negative).
- •Women over 25 (HIV-positive).
- •Treated for suspicious cervical lesions after a positive VIA screening.
Exclusion Criteria
- •History of hysterectomy.
- •Diagnosis of other histological invasive cervical cancer.
- •Suspicious cervical cancer cases.
- •Pregnancy.
- •Prior screening history.
- •Vaginal bleeding.
- •Lack of consent.
Outcomes
Primary Outcomes
Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
Time Frame: 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