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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-12-30

Brief Summary

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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:

* 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.

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Detailed Description

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Conditions

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Suspicious Cervical Cancer Lesions Follow up Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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.

Intervention Type BEHAVIORAL

Information already available

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.

Group Type EXPERIMENTAL

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.

Intervention Type BEHAVIORAL

Information already available

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.

Group Type EXPERIMENTAL

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.

Intervention Type BEHAVIORAL

Information already available

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.

Group Type ACTIVE_COMPARATOR

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.

Intervention Type BEHAVIORAL

Information already available

Interventions

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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.

Information already available

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No