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.: PACTR202011855730652 Date of Approval: 06/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A two-arm clustered-randomized control trial study on the effect of local handwashing agents on microbial contamination of hands in the rural settings of northwest Ethiopia: A study design and rationale
Official scientific title A two-arm clustered-randomized control trial study on the effect of local handwashing agents on microbial contamination of hands in the rural settings of northwest Ethiopia: A study design and rationale
Brief summary describing the background and objectives of the trial The hands are particularly important because they are the last line of defense in the chain of transmission of gastrointestinal pathogens and respiratory tract infections. Washing hands with rubbing agents such as soap sufficiently reduces the level of hand contamination and the spread of infections. As soap is not usually available due to cost, ash is often used as zero cost alternatives to soap for handwashing in the rural settings of Ethiopia. However, the effectiveness of ash to reduce microbial contamination of hands is not investigated. This study is, therefore, designed to assess the effect of handwashing with ash on microbial contamination of hands among mothers of under-three children in the rural settings of northwest Ethiopia. A two-arm clustered-randomized control trial will be employed. Stata version 14 is used to calculate number of clusters with the assumptions mentioned in the main text. A total of 11 clusters per arm will be selected using simple random sampling technique. In each arm a total of 220 mothers will be randomly included based on the inclusion and exclusion criteria. After providing health education on effective handwashing process, we will ask study subjects to do the usual activities. We will then take swab samples from the dominant hand before washing. After swabbing, participants will then asked to wash their hands with water only and with ash by following effective handwashing procedures with instructions on length of time or thoroughness and will be informed to dry their hands in the air. We will again take swab samples from the dominant hand after washing and drying. Finally, we will compare each intervention arm against the control. A generalized estimating equation(GEE) with robust standard error (SE) estimation will be used for the analysis to account the cluster nature of data. Statistically significant variables will be identified on the basis of adjusted betas with 95% CI and p-value < 0.05.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Microbial contamination of hands
Purpose of the trial Prevention
Anticipated trial start date 01/02/2021
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 440
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Experimental Group Handwashing with ash One day In this study, we will provide health education to both arms on effective hadwashing procedures and local rubbing agents (like ash) to the intervention groups. 220
Control Group Handwashing with water only One day The control arm will not use ash. Controls will be those mothers who continue with usual practice. 220 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This trial will be implemented among mothers of under-three children in Dabat district, northwest Ethiopia, where no similar interventions are not operating or planned in the intervention period. Participants will be recruited based on the following inclusion criteria: a) presence of 12-36 months age children in the household; b) mothers who are volunteer to be part of the experiment; c) mothers who are not using soap to wash hands; and d) geographical accessibility. Mothers or care givers having acute or chronic nail or skin disorders/lesions, including eczema dermal abrasion, trauma and infection will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 44 Year(s) Female
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 13/05/2020 Institutional review board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
Maraki Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome variable of this study is bacterial contamination of hands measured as mean bacterial count. We will use indicator microorganism, mainly E.coli. We will also identify parasites and fungi. We will follow approved guideline to identify or diagnose bacteria, parasites and fungi. Before and after washing hands
Secondary Outcome No secondary outcome Not applicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Public Health Chechela Gondar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Global One Health Initiative A100E Sisson Hall, 1920 Coffey Rd, Columbus, OH 43210 Columbus United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institutes of Health Fogarty International Center 31 Center Dr, Bethesda, MD 20892 MD United States of America University
COLLABORATORS
Name Street address City Postal code Country
Alemayehu Worku Yalew Black Lion Addis Ababa Ethiopia
Feleke Moges Science Amba Gondar Ethiopia
Jiyoung Lee 1841 Neil Avenue Columbus United States of America
Michael Bisesi 1841 Neil Avenue Columbus United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zemichael Gizaw zemichael12@gmail.com +251913348400 Science Amba
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Zemichael Gizaw zemichael12@gmail.com +251913348400 Science Amba
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Alemayehu Yalew alemayehuwy@yahoo.com +251911405652 Tikur Ambesa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be made available up on request of the principal investigator. Study Protocol Data will be made available within three months after the trial is completed. Open
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