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

Bahir Dar University

Status

Begins enrollment in 1 month

Conditions

Active Trachoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07767578

6060/2026

Details and patient eligibility

About

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.

Full 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.

Enrollment

990 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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