RecruitingNot ApplicableNCT06515301

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


Sponsor

Addis Ababa University

Enrollment

466 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether targeted interventions — such as reminder calls, patient education, and peer navigation — can improve how consistently women in Ethiopia return for follow-up care after being treated for pre-cancerous cervical lesions, which is critical for ensuring the treatment worked and catching any recurrence early. **You may be eligible if...** - You are a woman aged 30 to 49 (if HIV-negative) or over 25 (if HIV-positive) - You were treated for a suspicious cervical lesion after a positive VIA (visual inspection with acetic acid) screening **You may NOT be eligible if...** - You have had a hysterectomy - You have already been diagnosed with invasive cervical cancer - Your case is suspected (but not confirmed) cervical cancer - You are pregnant - You have had prior screening history - You have vaginal bleeding - You are unwilling to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntervention 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


Locations(1)

Worabe Health Center

Silte, Southern Ethiopia, Ethiopia

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NCT06515301