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Trial Title:
Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia: A Pragmatic RCT
NCT ID:
NCT06515301
Condition:
Suspicious Cervical Cancer Lesions Follow up Adherence
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
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.
Description:
Information already available
Arm group label:
Application-based automated SMS text reminders plus standard care.
Arm group label:
Home-visit reminders by health extension workers plus standard care.
Arm group label:
Standard care only
Arm group label:
Structured nurse-led telephone call reminders plus standard care.
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.
Criteria for 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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
49 Years
Healthy volunteers:
No
Start date:
September 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Addis Ababa University
Agency class:
Other
Source:
Addis Ababa University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06515301
