Improving follow-up after treatment for suspicious cervical lesions in Ethiopia

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

This project tests whether nurse phone calls, home visits by health extension workers, or automated SMS reminders help women keep follow-up appointments after treatment for suspicious cervical lesions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 466 (estimated)
• Ages: 25 Years to 49 Years
• Sex: Female
• Sponsor: Addis Ababa University (other)
• Locations: 1 site (Silte, Southern Ethiopia)
• Trial ID: NCT06515301 on ClinicalTrials.gov

What this trial studies

This is a pragmatic randomized trial conducted in primary health care settings in Silte, Southern Ethiopia, comparing three reminder approaches against standard care to improve post-treatment follow-up adherence. Participants are women treated for suspicious cervical lesions after a positive VIA screen, with age and HIV-status eligibility criteria. Interventions are structured nurse-led telephone call reminders, home-visit reminders by health extension workers, and an application-based automated SMS system, with adherence to scheduled follow-up as the primary outcome. The trial aims to determine which, if any, of these low-cost reminder strategies improves return rates in this low-resource setting.

Who should consider this trial

Good fit: Women treated for suspicious cervical lesions after a positive VIA screening at participating primary care sites who meet the age and HIV-status criteria and can give informed consent are eligible candidates.

Not a fit: Women with prior hysterectomy, diagnosed invasive cervical cancer, current pregnancy, active vaginal bleeding, prior screening history, or who cannot consent or be reached by the interventions are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, these reminder methods could raise follow-up rates and enable earlier detection and treatment, reducing progression to invasive cervical cancer.

How similar studies have performed: Similar reminder approaches such as phone calls and SMS have improved clinic attendance in other screening and appointment settings, though evidence specific to post-treatment cervical precancer follow-up in low-resource settings is limited.

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.

Where this trial is running

Silte, Southern Ethiopia

• Worabe Health Center — Silte, Southern Ethiopia, Ethiopia (RECRUITING)

Study contacts

• Study coordinator: Mr.Alemnew Destaw Mezgebu, MPH

Conditions: Suspicious Cervical Cancer Lesions Follow up Adherence