Clinical trial NCT06515301: Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia
Official title: Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suspicious Cervical Cancer Lesions Follow up Adherence
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 466
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Proportion of adherence to follow up recommendations in the intervention and standard group after suspicious cervical cancer lesion treatment.
timeFrame: re-screening (VIA) after one year (11-13 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Silte
country: Ethiopia
facility: Worabe Health Center
state: Southern Ethiopia
Study officials:
References: