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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:
Structured Nurse-Led Telephone Call Reminders
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured nurse-led telephone call reminders plus standard care. | Experimental | 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. |
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| Home-visit reminders by health extension workers plus standard care. | Experimental | 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. |
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| Application-based automated SMS text reminders plus standard care. | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | re-screening (VIA) after one year (11-13 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mr.Alemnew Destaw Mezgebu, MPH | Contact | +251979695905 | alemrondesta66@gmail.com | |
| Dr.Muluken Gizaw Turago, PhD | Contact | +251966809345 | muluken.gizaw@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worabe Health Center | Recruiting | Silte | Southern Ethiopia | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40730399 | Derived | Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner SS, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Follow-up rescreening uptake and persistent positive rates among women after positive cervical cancer screening results in Ethiopia: a longitudinal cross-sectional study. BMJ Open. 2025 Jul 28;15(7):e099955. doi: 10.1136/bmjopen-2025-099955. | |
| 39773801 |
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Individual participant data (IPD) will not be shared to maintain participant confidentiality and comply with ethical guidelines. However, aggregated, de-identified data will be made available upon reasonable request after study completion and publication. Requests should be directed to the corresponding author, and data access will be provided in line with institutional policies and BMJ Open's data-sharing policy requirements.
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| Standard care only | Active Comparator | 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. |
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| Destaw A, Getachew S, Getachew E, Shita A, Midaksa M, Rossner S, Kroeber ES, Addissie A, Kantelhardt EJ, Gizaw M. Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial. BMJ Open. 2025 Jan 7;15(1):e091693. doi: 10.1136/bmjopen-2024-091693. |