TrachomaWUHANCT02373657
Water Uptake for Health in Amhara Pilot
A study testing instruction in soap-making and hygiene education in people with Trachoma, run by University of California, San Francisco at 1 site in Ethiopia.
Trial summary
Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- instruction in soap-making and hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,068 participants
- Where
- 1 siteEthiopia
- Study dates
- Apr 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 residents residing in the state-teams which are randomly selected for this study.
Who cannot join
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.
- Conditions
- Trachoma
- Being tested
- instruction in soap-making and hygiene education
- Keywords
- trachoma, soil transmitted helminths, water, hand washing
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instruction in soap-making and hygiene educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| WASH Intervention | Experimental | In these seven communities we built a well in a central location for all state team residents. We plan on providing "tippy-taps" (water and soap dispensers), instruction in soap-making, and hygiene education to these communities. We will also put fly traps in the communities to see if wells reduce flies. We plan on performing monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. Receives: Behavioral: instruction in soap-making and hygiene education |
| Control | No intervention | In these seven communities, we plan to perform monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ocular chlamydia infection (0-5 year olds)
Measured: 24 months
Nasopharyngeal macrolide resistance (0-5 year olds)
Measured: 24 months
Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)
Measured: 24 months
Secondary outcomes (4)
Childhood growth (weight controlled for height among children aged 0-5 years at baseline)
Measured: 24 months
Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system
Measured: 24 months
Prevalence of enteric viruses using PCR (0-5 year olds)
Measured: 24 months
Self report childhood morbidity
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy D Keenan, MD, MPH, Principal investigator, F.I. Proctor Foundation, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373657
- Sponsor's protocol ID
- 10-02169-B
- Acronym
- WUHA
- Status last verified
- Jun 2021
- First submitted
- 23 Feb 2015
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Uptake for Health in Amhara Pilot
- ClinicalTrials.gov ID
- NCT02373657
- Acronym / sponsor ID
- WUHA / 10-02169-B
- Conditions
- Trachoma
- Keywords
- trachoma, soil transmitted helminths, water, hand washing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,068 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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.
Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WASH Intervention | Experimental | Behavioral: instruction in soap-making and hygiene educationIn these seven communities we built a well in a central location for all state team residents. We plan on providing "tippy-taps" (water and soap dispensers), instruction in soap-making, and hygiene education to these communities. We will also put fly traps in the communities to see if wells reduce flies. We plan on performing monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. |
| Control | No intervention | –In these seven communities, we plan to perform monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents residing in the state-teams which are randomly selected for this study.
Key exclusion criteria (1 listed)
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
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 |
|---|---|---|
| instruction in soap-making and hygiene education | Behavioural | WASH Intervention |
Primary outcome
Prevalence of ocular chlamydia infection (0-5 year olds)
Time frame: 24 months
Nasopharyngeal macrolide resistance (0-5 year olds)
Time frame: 24 months
Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)
Time frame: 24 months
4 secondary outcomes
Childhood growth (weight controlled for height among children aged 0-5 years at baseline)
Time frame: 24 months
Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system
Time frame: 24 months
Prevalence of enteric viruses using PCR (0-5 year olds)
Time frame: 24 months
Self report childhood morbidity
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Related trials for Trachoma
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
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. This study is not recruiting at the moment.
Jeremy D Keenan, MD, MPH principal investigator
F.I. Proctor Foundation, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instruction in soap-making and hygiene education in people with Trachoma, run by University of California, San Francisco at 1 site in Ethiopia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ocular chlamydia infection (0-5 year olds) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 29 Jun 2021.