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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorAddis Ababa University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 30-49 (HIV-negative).

Women over 25 (HIV-positive).

Treated for suspicious cervical lesions after a positive VIA screening.

Disqualifiers

History of hysterectomy.

Diagnosis of other histological invasive cervical cancer.

Suspicious cervical cancer cases.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

    Behavioral

    Information already available

Treatment groups

466 Participants
are divided into 4 treatment groups
Group A: Structured nurse-led telephone call reminders plus standard care.Experimental treatment 1 intervention
Group B: Home-visit reminders by health extension workers plus standard care.Experimental treatment 1 intervention
Group C: Application-based automated SMS text reminders plus standard care.Experimental treatment 1 intervention
Group D: Standard care onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
re-screening (VIA) after one year (11-13 months)

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Worabe Health CenterRecruiting Silte, Southern EthiopiaEthiopiaEthiopia

Sponsors and contacts

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