Investigating different face-washing methods for reducing the chance of spreading the infection that causes trachoma
| ISRCTN | ISRCTN12814010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12814010 |
| Secondary identifying numbers | LSHTM Ethics Reference 16470 |
- Submission date
- 12/03/2023
- Registration date
- 17/04/2023
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Trachoma, a Neglected Tropical Disease (NTD), is the commonest infectious cause of blindness globally, affecting some of the world’s poorest communities. Trachoma elimination requires implementation of the World Health Organization (WHO)-endorsed SAFE strategy: Surgery for trichiasis; Antibiotics to treat infection; Facial cleanliness and Environmental improvement to reduce transmission. Improving the evidence base for the “F” component of the SAFE strategy for trachoma elimination is highlighted as a critical action to reach 2030 targets in the WHO NTD Roadmap 2021–2030; the proposed research directly addresses that critical action. There is currently a lot of international momentum to understand better the “F” component of the SAFE strategy to improve both resource allocation and intervention effectiveness. This study is the first of its kind to explore whether and how face washing can remove Chlamydia trachomatis (Ct) bacteria from children’s faces. The proposed study leverages collaborations formed during the Stronger-SAFE trial and builds on published pilot work conducted in Ethiopia in 2018.
The aim of this study is to assess the effectiveness of different face cleansing protocols at removing Chlamydia trachomatis (Ct) bacteria and eye/nose secretions from the faces of children with active trachoma. The study will also assess how long it takes for Ct to build up again on children’s faces after they are washed.
Who can participate?
Children aged 1−7 years with severe follicular and/or papillary inflammation and their caregivers
What does the study involve?
Programmatic trachoma survey data will be reviewed to identify high prevalence woredas (districts of Ethiopia). Participants will be identified through screening of children for clinical signs of severe trachoma in suspected high-prevalence communities of Ethiopia. Once parental consent has been obtained, the researchers will take a conjunctival (eye) swab to test for Ct infection, swab each child’s face and hands for Ct and assess facial cleanliness. Recruited children will be randomly allocated into three equal groups: face washing with water only, face washing with water and soap and face washing with a SuperTowel. Following face washing, each child’s face and hands will be swabbed again for Ct. Swabbing will be repeated at regular intervals up to 8 hours.
What are the possible benefits and risks of participating?
This is a low-risk study and very few risks have been identified to taking part. There is a small risk of allergy or sensitivity to soap or SuperTowel products, but as the intervention only lasts 30 seconds a severe reaction is very unlikely. There is a risk of getting soap in the eye which can be sore, but discomfort would only be temporary.
Participants will receive a bar of soap at the end of the trial, in recognition of the wider role soap plays in hygienic behaviours. Participants with trachoma will receive antibiotic treatment. Those screened who either are not eligible or decline consent will also receive treatment. Participants may also receive a small token of appreciation (a pen, a football, etc). There are no other benefits to taking part.
Where is the study run from?
The study is a collaboration between the London School of Hygiene & Tropical Medicine (UK) and Berhane Public Health Consultancy (Ethiopia). Oromia Regional Health Bureau and Fred Hollows Foundation Ethiopia are also contributing to the study.
When is the study starting and how long is it expected to run for?
January 2019 to June 2023
Who is funding the study?
Reckitt Global Hygiene Institute
Who is the main contact?
1. Katie Greenland, katie.greenland@lshtm.ac.uk
2. Wondu Alemayehu, walemayehu@berhan-health.org
Contact information
Principal Investigator
Keppel Street
London
WC1E 7HT
United Kingdom
 ORCID ID |
0000-0002-3331-0377 |
|---|---|
| Phone | +44 (0)20 79272223 |
| katie.greenland@lshtm.ac.uk |
Principal Investigator
Yeka SC, Woreda 6, House No 064/U
Addis Ababa
-
Ethiopia
| Phone | +251 (0)910 574847 |
|---|---|
| walemayehu@berhan-health.org |
Study information
| Study design | Three-arm open parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The Face Washing Methods (FAWASH) trial: an open, parallel-group randomized controlled trial comparing face washing methods for the removal of Chlamydia trachomatis |
| Study acronym | FAWASH |
| Study objectives | Face washing with water and soap will remove Chlamydia trachomatis from more children's faces than face washing with water alone. |
| Ethics approval(s) | 1. Approved 02/02/2023, London School of Hygiene & Tropical Medicine Interventions Ethics Committee (Keppel Street, London, WC1E 7HT, UK; +44 (0)207 636 8638; ethics@lshtm.ac.uk), ref: 16470 2. Approved 26/01/2023, Ethiopian Food and Drug Authority (PO Box 5681, Addis Ababa, Ethiopia; +251 (0)552 414 123; regulatory@fmhaca.gov.et), ref: 02/25/33/01 3. Approved 22/07/2022; Ethiopia Ministry of Education National Health Research Ethics Committee (PO Box 1367, Arada sub-city, Addis Ababa, Ethiopia, +251 (0)11 155 3133; info@moe.gov.et), ref: 03/246/938/22 4. Approved 20/02/2023, Oromia Regional Health Bureau (PO Box 24341, Addis Ababa, Ethiopia; +251 (0)113 717 277; ohbhead@telecom.net.et), ref BF/UBT/V?H6/10002 |
| Health condition(s) or problem(s) studied | Removal of Chlamydia trachomatis from the face of children aged 1-7 years with ocular C. trachomatis infection |
| Intervention | Participants are randomized to one of the three arms in a 1:1:1 ratio at the point of wash using a random number generator: Protocol A: Caregiver delivers a 30-second face wash with water only Protocol B: Caregiver delivers a 30-second face wash with water and soap Protocol C: Caregiver delivers a 15-20 second face wash with a damp SuperTowel In all protocols caregivers are instructed to wash their children’s faces in a natural manner, but take care to reach all areas of the face. |
| Intervention type | Behavioural |
| Primary outcome measure | Relative reduction in the proportion of participants without Chlamydia trachomatis detected on faces by real-time PCR immediately following face washing with soap and water, compared with the face washing with water only group |
| Secondary outcome measures | 1. Relative reduction in the proportion of participants without Chlamydia trachomatis detected on faces by real-time PCR immediately following face wiping with the SuperTowel, as compared to the water-only arm 2. Difference between arms in the proportion of participants without ocular or dry nasal discharge on faces, measured by consensus observation, immediately following washing/wiping protocol 3. Difference between arms in the mean load of Chlamydia trachomatis on faces, measured by real-time PCR, immediately following the washing/wiping protocol 4. Difference between arms in the proportion of participants without Chlamydia trachomatis (by real-time PCR)/ocular and nasal discharge (by consensus observation) on faces at 1, 2, 4, 6 and 8 hours following the washing/wiping protocol 5. Mean increase in load of Chlamydia trachomatis, measured by real-time PCR, on faces at 1, 2, 4, 6 and 8 hours following protocol |
| Overall study start date | 30/01/2019 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 470 |
| Key inclusion criteria | 1. Parental consent to take part 2. Participant assent to take part 3. Severe conjunctival inflammation (F3 and/or P3) 4. Aged 1-7 years residents of Oromia State, Ethiopia 5. Availability for the study period (8 hours) |
| Key exclusion criteria | 1. Known allergy to study materials 2. Significant facial and/or ocular injury or pathology |
| Date of first enrolment | 20/03/2023 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Ethiopia
Study participating centre
Ethiopia
Sponsor information
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7927 2626 |
|---|---|
| rgio@lshtm.ac.uk | |
| Website | https://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Scientific results will be published in open access peer-reviewed journals and presented at relevant international conferences. Results will also be disseminated to trial stakeholders and the wider trachoma control community. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Katie Greenland (katie.greenland@lshtm.ac.uk) upon study publication. Added 11/06/2024: Fully anonymised data will be deposited in a public repository following publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.1 | 09/01/2023 | 11/06/2024 | No | No |
Additional files
Editorial Notes
23/04/2025: The intention to publish date was changed from 31/12/2024 to 31/12/2025.
12/06/2024: The registration was initiated on 12/03/2023 and finalised on 17/04/2023. Following the prospective submission on 12/03/2023, there were no subsequent changes to the protocol. The recruitment started on 20/03/2023, after the initiation of public registration.
11/06/2024: The following changes were made to the study record:
1. The overall study end date was changed from 30/06/2024 to 30/06/2023.
2. The intention to publish date was changed from 30/06/2025 to 31/12/2024.
3. Contact details updated.
4. Protocol uploaded.
5. IPD sharing plan added.
13/03/2023: Trial's existence confirmed by the Ethiopian Food and Drug Authority.
