Active Trachoma
Conditions
Keywords
Hand and Face washing practice
Brief summary
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.
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.
Interventions
BEHAVIORALA 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.
Sponsors
Bahir Dar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the behavioral and community-based nature of the intervention, blinding of participants and intervention implementers will not be feasible, as mothers in the intervention group will be aware of receiving structured hygiene promotion activities.
Intervention model description
A randomised controlled trial (RCT) design with a parallel, two-arm (intervention and control) structure will be conducted among mothers with children 1-9 years of age in South Sodo, Sodo, Silti, and East Silti districts, Central Ethiopia Region, Ethiopia.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of hand and face washing with soap on active trachoma | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of hand and face washing with soap on active trachoma | 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). |
Contacts
CONTACTWubante Yalew, Master Degree
CONTACTAmha Admassie, Ph.D.
STUDY_DIRECTORHigemengist Astatkie, Ph.D.
Bahir Dar University, Collage of Medicine and Health science
Outcome results
None listed