Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06515301
Enrollment
466
Registered
2024-07-23
Start date
2024-11-20
Completion date
2025-12-30
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspicious Cervical Cancer Lesions Follow up Adherence

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.

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

Sponsors

Addis Ababa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.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

Countries

Ethiopia

Contacts

Primary ContactMr.Alemnew Destaw Mezgebu, MPH
alemrondesta66@gmail.com+251979695905
Backup ContactDr.Muluken Gizaw Turago, PhD
muluken.gizaw@yahoo.com+251966809345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026