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Recruiting NCT06515301

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

No phase Interventional Suspicious Cervical Cancer Lesions Follow up Adherence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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..
Who it may be relevant to
Registry conditions: Suspicious Cervical Cancer Lesions Follow up Adherence. Basic parameters: 25 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ethiopia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Ethiopia · 1 center
  • Worabe Health Center — Silte

Publications

  • Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner SS, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Follow-up rescreening uptake and persistent positive rates among women after positive cervical cancer screening results in Ethiopia: a longitudinal cross-sectional study. BMJ Open. 2025 Jul 28;15(7):e099955. doi: 10.1136/bmjopen-2025-099955. PMID 40730399
  • Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner S, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial. BMJ Open. 2025 Jan 7;15(1):e091693. doi: 10.1136/bmjopen-2024-091693. PMID 39773801

Identifiers

NCT: NCT06515301 · 008/24/SPH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗