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

June 5, 2025 updated by: Alemnew Destaw Mezgebu, Addis Ababa University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
    • Southern Ethiopia
      • Silte, Southern Ethiopia, Ethiopia
        • Recruiting
        • Worabe Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured nurse-led telephone call reminders plus standard care.
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.
Information already available
Experimental: Home-visit reminders by health extension workers plus standard care.
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.
Information already available
Experimental: Application-based automated SMS text reminders plus standard care.
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.
Information already available
Active Comparator: Standard care only
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
re-screening (VIA) after one year (11-13 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addis Ababa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008/24/SPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suspicious Cervical Cancer Lesions Follow up Adherence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe