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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 49
Healthy Volunteers: f
View:

• Women aged 30-49 (HIV-negative).

• Women over 25 (HIV-positive).

• Treated for suspicious cervical lesions after a positive VIA screening.

Locations
Other Locations
Ethiopia
Worabe Health Center
RECRUITING
Silte
Contact Information
Primary
Mr.Alemnew Destaw Mezgebu, MPH
alemrondesta66@gmail.com
+251979695905
Backup
Dr.Muluken Gizaw Turago, PhD
muluken.gizaw@yahoo.com
+251966809345
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 466
Treatments
Experimental: Structured nurse-led telephone call reminders plus standard care.
Participants in this arm will receive proactive telephone call reminders from nurses for their scheduled follow-up visits. Reminders will be administered initially at 4 months post-recruitment and then every 4 months for a year for HIV-negative women. For women living with HIV, reminders will be administered every 2 months for 6 months after recruitment.
Experimental: Home-visit reminders by health extension workers plus standard care.
Health Extension Workers (HEWs) will conduct home visits to remind participants of their scheduled follow-up appointments. Scheduled initially at 4 months post-recruitment for HIV-negative women and 2 months for HIV-positive women, followed by visits every 2 months for 6 months for HIV-positive individuals and every 4 months for 12 months for HIV-negative individuals.
Experimental: Application-based automated SMS text reminders plus standard care.
Participants will receive automated SMS text reminders via a mobile application for their follow-up visits. SMS reminders will be sent initially at 4 months and 2 months post-recruitment for HIV-negative and HIV-positive women, respectively. Subsequent reminders will be sent every 2 months for 6 months for HIV-positive women and every 4 months for 12 months for HIV-negative women.
Active_comparator: Standard care only
Participants in the control group will receive standard follow-up care according to the guidelines outlined by the Ethiopian Ministry of Health and current clinical practices of the country.These women will be orally informed of their follow-up appointment dates and will receive a post-treatment follow-up card at the baseline. Apart from this information and routine care, no additional interventions will be provided.
Related Therapeutic Areas
Sponsors
Leads: Addis Ababa University

This content was sourced from clinicaltrials.gov