Key Interventions to Improve the Follow-up Adherence Post Cervical Precancerous Lesion Treatment in Ethiopia

NCT06515301RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Addis Ababa University

Enrollment

466

Start Date

2024-11-20

Completion Date

2025-11-20

Study Type

INTERVENTIONAL

Official Title

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

Interventions

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.

Conditions

Suspicious Cervical Cancer Lesions Follow up Adherence

Eligibility

Age Range

25 Years – 49 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: re-screening (VIA) after one year (11-13 months)

Locations

Worabe Health Center, Silte, Ethiopia

Linked Papers

2025-07-28

Follow-up rescreening uptake and persistent positive rates among women after positive cervical cancer screening results in Ethiopia: a longitudinal cross-sectional study

Objective To assess cervical cancer screening positivity rates, follow-up rescreening uptake 1 year after treatment and persistent positivity among women with initial positive screening results in Ethiopia. The study also explored reasons for loss to follow-up and preferences for reminder strategies. Design Longitudinal cross-sectional study. Settings 10 primary healthcare facilities in Oromia and southern and central Ethiopia. Participants From November 2022 to April 2024, 17 586 women screened for cervical cancer. Of these 768 (4.4%) had positive screening results, and 515 women treated at the primary level were included to assess follow-up rescreening uptake. An additional 139 women who did not return for follow-up were interviewed to identify reasons for non-uptake and reminder preferences. Result Of the 515 women included in the analysis, 179 (34.8%, 95% CI: 30.6% to 38.8%) returned for follow-up rescreening. Among those re-screened, the persistent visual inspection with acetic acid (VIA) positivity rate was 16.1% (95% CI: 11.0% to 21.7%). Factors significantly associated with follow-up rescreening uptake included age over 40 (adjusted OR (AOR): 2.5; 95% CI: 1.34 to 5.00), urban residence (AOR: 1.7; 95% CI: 1.15 to 2.58), secondary or higher education (AOR: 2.0; 95% CI: 1.06 to 4.12) and HIV-positive status (AOR: 2.4; 95% CI: 1.27 to 4.87). Among the 139 women contacted, the main reasons for non-uptake were lack of time, forgetting appointments, visiting another facility and pregnancy. Regarding preferred reminders, 93% favoured text messages and all agreed to phone calls or home visits. Conclusion One-third of women adhered to follow-up rescreening after a positive cervical cancer screening in Ethiopia, revealing a considerable gap since those women had a three times higher chance of being VIA positive compared with the first screening. Older age, urban residence, higher education and HIV-positive status were significantly linked to follow-up rescreening uptake. Addressing barriers such as time constraints and forgotten appointments through tailored reminder strategies is essential for improving the follow-up rescreening uptake. Contextualised interventions can strengthen rescreening for finding those women at very high risk for cervical lesions and strengthen cervical cancer prevention in Ethiopia. Trial registration number NCT06515301 .

2025-01-07

Study protocol for key interventions to improve the follow-up adherence postcervical precancerous lesion treatment in Ethiopia: a pragmatic randomised controlled trial

Introduction The follow-up adherence after treatment for a positive screening test is critical for preventing the development of screen‐detected abnormalities in cervical cancer. Yet, this poses a major challenge in developing countries like Ethiopia, emphasising the urgency for intervention strategies. Our trial aims to assess which strategies would be effective in improving adherence to follow-up after suspicious cervical lesion treatment in Ethiopia. Thus, the objective of this study is to evaluate key interventions to improve the follow-up adherence rate among women treated for suspicious cervical lesions in primary healthcare settings in Ethiopia. Method and analysis We will employ a pragmatic randomised control trial study design, using Consolidated Standards of Reporting Trials guidelines for reporting and a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist for developing the protocol, to evaluate intervention effectiveness. These interventions are: (a) structured nurses-led telephone call reminders, (b) home-visit reminders led by health extension workers and (c) application-based automated short message service text reminders. The standard care involves only receiving oral follow-up advice and a baseline follow-up card. The planned start date is 1 November 2024, with an anticipated end date of 1 November 2025. Our study will include women aged 30–49 who are HIV-negative and those over 25 who are HIV-positive, and who have been treated for suspicious cervical lesions after a positive visual inspection with acetic acid (VIA) screening, as per Ethiopian Ministry of Health guidelines for cervical cancer screening eligibility. The required sample size is 460, with 115 participants per arm. Study participants in the intervention group will receive the stated interventions plus the standard care, while the control group will receive only the standard care. The interventions will be delivered three times annually: 4 months from baseline, then at 8 months and finally at 12 months before the appointment due date. The primary outcome of our study is the proportion of adherence to follow-up recommendations, which will be measured by rescreening (VIA) after 1 year (11–13 months after the first screening). Descriptive statistics, χ2 test (Fisher’s exact test), binary logistic regression analysis and intention-to-treat will be used to describe and interpret the results. Ethics and dissemination The trial protocol has been approved by the institutional review board of Addis Ababa University with protocol number (008/24/SPH). Trial results will be disseminated to study participants, national and international audiences through workshops, conferences and publications in reputable journals. Trial registration number NCT06515301.