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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 990
- 主要终点
- The effect of hand and face washing with soap on active trachoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention Group: Participants receive routine health care services in addition to a structured hy
干预措施: 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)
Control group receive routine health care services
Participants receive routine health care services without additional behavioral intervention
干预措施: 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)
结局指标
主要结局
The effect of hand and face washing with soap on active trachoma
时间窗: 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.
次要结局
- 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.)
研究者
Wubante Yalew
Principal Investigator
Bahir Dar University