Active TrachomaNCT07767578
The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
A study testing 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 in people with Active Trachoma, run by Bahir Dar University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Active Trachoma
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Active Trachoma
- Being tested
- 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
- Keywords
- Hand and Face washing practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured Health Belief Model (HBM)-based behavioural intervention delivered over 24 weeks, comprising interactive health education, behaviour change communication, skills training, and practical dBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Participants receive routine health care services in addition to a structured hy | Experimental | Not described Receives: 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 |
| Control group receive routine health care services | Active comparator | Participants receive routine health care services without additional behavioral intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active TrachomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wubante Yalew, Bahir Dar University
- Investigators
- Higemengist Astatkie, Ph.D., Study director, Bahir Dar University, Collage of Medicine and Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767578
- Sponsor's protocol ID
- 6060/2026
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including baseline characteristics, intervention allocation, outcome measures, and relevant covariates, will be made available upon reasonable request to the corresponding author after publication of the primary results. Data will be shared with qualified researchers who submit a scientifically sound proposal, in accordance with ethical and confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07767578
- Acronym / sponsor ID
- 6060/2026
- Conditions
- Active Trachoma
- Keywords
- Hand and Face washing practice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Participants receive routine health care services in addition to a structured hy | Experimental | 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 |
| Control group receive routine health care services | Active comparator | 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 dParticipants receive routine health care services without additional behavioral intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A structured Health Belief Model (HBM)-based behavioural intervention delivered over 24 weeks, comprising interactive health education, behaviour change communication, skills training, and practical dThis 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. | Behavioural | Control group receive routine health care services, Intervention Group: Participants receive routine health care services in addition to a structured hy |
Primary outcome
The effect of hand and face washing with soap on active trachoma
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.
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.
1 secondary outcome
The effect of hand and face washing with soap on active trachoma
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including baseline characteristics, intervention allocation, outcome measures, and relevant covariates, will be made available upon reasonable request to the corresponding author after publication of the primary results. Data will be shared with qualified researchers who submit a scientifically sound proposal, in accordance with ethical and confidentiality requirements.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Higemengist Astatkie, Ph.D. study director
Bahir Dar University, Collage of Medicine and Health science
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Active Trachoma, run by Bahir Dar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wubante Yalew, Master Degree (+251 948843175, wubanteya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of hand and face washing with soap on active trachoma (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.