About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
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
BehavioralThis 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.
Treatment groups
Trial outcomes
Primary outcomes
The effect of hand and face washing with soap on active trachoma
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.
Secondary outcomes
The effect of hand and face washing with soap on active trachoma
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).
Locations
Sponsors and contacts
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