The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.

August 11, 2026 updated by: Wubante Yalew, Bahir Dar University

The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old in Central Ethiopia Region: a Randomized Controlled Trial

Active trachoma remains a major public health problem among children in Ethiopia. This clinical trial evaluates whether regular hand and face washing with soap reduces the prevalence of active trachoma among children aged 1-9 years in the Central Ethiopia Region. The primary outcome is the prevalence of active trachoma after the intervention, with findings expected to support evidence-based hygiene interventions for trachoma prevention and control.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Trachoma remains a leading cause of preventable blindness and continues to be a significant public health problem in Ethiopia, particularly among children living in endemic rural communities. Repeated infection with Chlamydia trachomatis leads to chronic conjunctival inflammation, which can ultimately result in blindness if left untreated. Children aged 1-9 years constitute the primary reservoir for infection, and poor facial hygiene, inadequate hand hygiene, and limited access to water and sanitation contribute substantially to disease transmission.

This clinical trial is designed to evaluate the effectiveness of regular hand and face washing with soap in reducing the prevalence of active trachoma among children aged 1-9 years in the Central Ethiopia Region. Participants will be assigned to an intervention group receiving structured promotion and provision of soap for routine hand and face washing, or to a control group receiving the standard community practices or existing health education, according to the study protocol. The intervention will emphasize consistent face washing to remove ocular and nasal discharge and hand washing with soap to reduce the transmission of C. trachomatis.

The primary outcome will be the prevalence of active trachoma, assessed using the World Health Organization (WHO) simplified trachoma-grading system by trained and certified graders at baseline and at the end of the follow-up period. Secondary outcomes may include facial cleanliness, adherence to hand- and face-washing practices, ocular and nasal discharge, and other hygiene-related behavioral indicators.

The study will also assess the feasibility and acceptability of implementing regular soap-based hygiene interventions in endemic communities. Findings from this trial are expected to strengthen the evidence base for the facial cleanliness component of the WHO SAFE strategy (Surgery, Antibiotics, Facial cleanliness, and Environmental improvement) and inform policies and programs aimed at accelerating trachoma elimination in Ethiopia and other endemic settings. Ethical approval is obtained from Bahir Dar University and the College of Medicine and Health Sciences Institutional Review Board, and informed consent will be obtained from parents or legal guardians before participant enrollment.

Study Type

Interventional

Enrollment (Estimated)

990

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All selected households in the South Sodo, Sodo, Silti, and East Silti districts with children 1-9 years of age.
  • Participants who have lived in the area for at least six months before the study.
  • Mothers or caregivers who give informed consent to participate in the study.

Exclusion Criteria:

  • Mothers or caregivers who are critically ill at the time of data collection,
  • Children with severe ocular disease that prevents accurate assessment of active trachoma,
  • Households planning permanent relocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group: Participants receive routine health care services in addition to a structured hy
Behavioral: A structured Health Belief Model (HBM)-based behavioural intervention delivered over 24 weeks, comprising interactive health education, behaviour change communication, skills training, and practical d

This intervention is distinguished from other trachoma prevention interventions by its comprehensive, theory driven, and behavior focused approach. Unlike routine hygiene promotion, which typically provides general health education, this study combines structured behavior change communication with the regular provision of soap and practical hand and face washing demonstrations over a six month period.

The Health Belief Model (HBM), addressing key behavioral constructs including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy, guides the intervention. Educational sessions are tailored to these constructs to promote sustained behavior change among mothers or primary caregivers of children aged 1 to 9 years.
Active Comparator: Control group receive routine health care services
Participants receive routine health care services without additional behavioral intervention
Behavioral: A structured Health Belief Model (HBM)-based behavioural intervention delivered over 24 weeks, comprising interactive health education, behaviour change communication, skills training, and practical d

This intervention is distinguished from other trachoma prevention interventions by its comprehensive, theory driven, and behavior focused approach. Unlike routine hygiene promotion, which typically provides general health education, this study combines structured behavior change communication with the regular provision of soap and practical hand and face washing demonstrations over a six month period.

The Health Belief Model (HBM), addressing key behavioral constructs including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy, guides the intervention. Educational sessions are tailored to these constructs to promote sustained behavior change among mothers or primary caregivers of children aged 1 to 9 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of hand and face washing with soap on active trachoma
Time Frame: Outcome will be assessed at baseline and 6 months after initiation of the intervention. Thus, each participant will be followed and assessed over a 6-month period, with the final outcome assessment conducted at approximately 6 months after baseline.
Active trachoma will be assessed among children aged 1 to 9 years through clinical examination of both eyes using the WHO simplified trachoma grading system. Each eye will be examined separately for the presence or absence of trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI). TF will be defined as the presence of five or more follicles, each at least 0.5 mm in diameter, in the central upper tarsal conjunctiva. TI will be defined as pronounced inflammatory thickening of the upper tarsal conjunctiva that obscures more than half of the normal deep tarsal vessels. For each eye, TF and TI will be recorded as 1 = Yes (present) and 0 = No (absent). Active trachoma will be considered present if TF and/or TI is present in either eye.
Outcome will be assessed at baseline and 6 months after initiation of the intervention. Thus, each participant will be followed and assessed over a 6-month period, with the final outcome assessment conducted at approximately 6 months after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of hand and face washing with soap on active trachoma
Time Frame: The secondary outcome will be assessed at baseline and again 6 months after initiation of the intervention to determine changes in hand and face-washing practices over the intervention period.
Change in hand and face-washing practices will be assessed using a 9-item structured questionnaire measuring adherence to recommended hand and face-washing behaviors. Each item will be scored as 1 (practice performed) or 0 (practice not performed).
The secondary outcome will be assessed at baseline and again 6 months after initiation of the intervention to determine changes in hand and face-washing practices over the intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahir Dar University

Investigators

  • Study Director: Higemengist Astatkie, Ph.D., Bahir Dar University, Collage of Medicine and Health science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

August 7, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6060/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including baseline characteristics, intervention allocation, outcome measures, and relevant covariates, will be made available upon reasonable request to the corresponding author after publication of the primary results. Data will be shared with qualified researchers who submit a scientifically sound proposal, in accordance with ethical and confidentiality requirements.

IPD Sharing Time Frame

After publication of the main finding

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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