Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515301
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia A Pragmatic RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia A Pragmatic Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None