Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103829129395 Date of Approval: 24/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of soap on communal Handwashing water as a source of faecal contamination during mealtime in households using the same bowl.
Official scientific title The effect of soap on communal Handwashing water as a source of faecal contamination during mealtime in households using the same bowl.
Brief summary describing the background and objectives of the trial Diarrhoea is one of the leading causes of death in Sub-Saharan Africa and in Mali. Improper handwashing techniques that include communal bowl handwashing in Mali and West Africa are considered to be a major source of enteric infection (resulting in diarrhoea) or acute respiratory infection. Members of the same family washing their hands in the same bowl before meals is practiced in many communities in Mali, and may result in increased transmission of pathogens by hands. This practice may increase the risk of hand contamination for family members during handwashing especially for the last ones. Communities justify this practice by the consolidation of social bonds, resulting in difficulty changing it. This study aims to conduct a feasibility trial to test a simple intervention that may be culturally acceptable and low cost. The intervention is the use of soap which to alter this practice, which may be a possible method of creating a culturally grounded handwashing practice to improve the hand hygiene. Participants will be randomised into either. the control arm (without soap) or intervention arm (with soap). We will collect water samples from the communal bowl before and after hand washing, and also collect hand swabs from the 5th person before and after the handwashing. The samples will be processed in the lab for coliform/E.coli counts for not only the measurement of the impact of the practice on the last person’s hands but also the improvement among those using the soap. The reasons that motivate people continuing the practice and their willingness to adhere to the soap use will be assessed using a questionnaire.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied Diarrhoea and respiratory diseases,Ebola,Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 05/07/2021
Actual trial start date 05/07/2021
Anticipated date of last follow up 02/08/2021
Actual Last follow-up date 28/08/2021
Anticipated target sample size (number of participants) 280
Actual target sample size (number of participants) 293
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Water Only group Maximum 1 minute per member. During the Handwashing process, five household members will use only water to wash their hands in the communal bowl. The last person (5th) is the person of interest for the Laboratory procedures. 140 Historical
Experimental Group Water and Soap group maximum 1 minute per member During the Handwashing process, five household members will use soap to wash their hands in the communal bowl. The last person (5th) is the person of interest for the Laboratory procedures. 140
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HOUSEHOLDS: • Households using the same bowl to wash hands before meals (in their habits) • Or neighbours if the number of family members (adults) is not at least up to 5. HOUSEHOLD MEMBERS WASHING THEIR HANDS DURING THE EXPERIMENT: • Adults and adolescents who can properly wash their hands • Uses the common bowl with other family members • 3 adults between 20 and 50 years of age • 2 young adults 10-20 years old QUESTIONNAIRE ADMINISTRATION: • Head of household (questionnaire) • The oldest adult who can answer the question if the head of household is not available (questionnaire) LAB SAMPLE COLLECTION: • Last person (5th) during the handwashing experiment initiated by the research team • A young adult between 14-20 years HOUSEHOLDS: • already using soap in handwashing • less than 3 family members of the required sex available for study HOUSEHOLD MEMBERS WASHING THEIR HANDS DURING THE EXPERIMENT: • not available for the study • Opposite sex to the sample being collected in the household QUESTIONNAIRE ADMINISTRATION: • Household members who cannot answer questions on the household LAB SAMPLE COLLECTION: • Young people who cannot properly wash their hand Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/03/2021 Ethics Review Committee of the Faculty of Medicine and OdontoStomatology and the Faculty of Pharmacy
Ethics Committee Address
Street address City Postal code Country
Rue Hopital du PointG Bamako BP 1832 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study will be the colony counts of faecal indicator bacteria on hands. None
Secondary Outcome The secondary outcome is the faecal indicator bacteria presence in the water used for handwashing. None
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tienfala Community Various places i.e in Households Koulikoro region. Mali
Djalakoroba Community Various Places i.e Households Koulikoro Region Mali
Zantiguila Community Various places i.e Households Koulikoro region Mali
Banconi community Various places i.e Households Bamako Mali
Sabalibougou Community Various places i.e Households Bamako Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Birmingham Birmingham Edgbaston B15 2TT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Birmingham Edgbaston Edgbaston B15 2TT United Kingdom University
Primary Sponsor University of Science Techniques and Technology Bamako University of Science Techniques and Technology Bamako Bamako Mali University
COLLABORATORS
Name Street address City Postal code Country
Ousmane Toure University of Science Techniques and Technology Bamako Bamako Mali
Ousmane Koita University of Science Techniques and Technology Bamako Bamao Mali
Cheick Sidibe University of Science Techniques and Technology Bamako Bamako Mali
Ryan Rego University of Birmingham Birmingham United Kingdom
Semira Manaseki Holland University of Birmingham Birmingham United Kingdom
Evans Asamane University of Birmingham Birmingham United Kingdom
Ibrahim Keita University of Sciences Techniques and Technologies of Bamako Bamako BPE 3206 Mali
Lansana Sangare University of Sciences Techniques and Technologies of Bamako Bamako BPE 3206 Mali
Modibo Telly University of Sciences Techniques and Technologies of Bamako Bamako BPE 3206 Mali
Lassina Doumbia University of Sciences Techniques and Technologies of Bamako Bamako BPE 3206 Mali
Mamadou Bado Traore University of Sciences Techniques and Technologies of Bamako Bamako BPE 3206 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ousmane Toure oussou_toure@hotmail.com +22366729013 University of Science Techniques and Technology Bamako
City Postal code Country Position/Affiliation
Bamako Mali Director
Role Name Email Phone Street address
Public Enquiries Youssouf Diarra hollandediarra@gmail.com +22391616158 University of Science Techniques and Technology Bamako
City Postal code Country Position/Affiliation
Bamako Mali Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Youssouf Diarra hollandediarra@gmail.com +22391616158 University of Science Techniques and Technology Bamako
City Postal code Country Position/Affiliation
Bamako Mali Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study participants’ personal information will never be discussed with anyone outside the study. Information about participants and their households will be kept private and confidential. Access to data will be limited to only the investigators. No one, other than these people will have access to the data and the data will be used solely for purposes of research and not to any other use. Informed Consent Form,Statistical Analysis Plan,Study Protocol Participant personal information will never be discussed outside the study. All reports and publications will omit participant personal information, and will be reported in aggregate format. Data is available upon request 6 months after trial completion but will be stripped of participant identifiers. Only Investigators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information