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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBahir Dar University

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 volunteers

Qualifiers

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

Design model

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

    Behavioral

    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.

Treatment groups

990 Participants
are divided into 2 treatment groups
Group A: Intervention Group: Participants receive routine health care services in addition to a structured hyExperimental treatment 1 intervention
Group B: Control group receive routine health care servicesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Secondary outcomes

1

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).

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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