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.: PACTR202404878631304 Date of Approval: 24/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of hygienic practice Intervention on reducing intestinal parasitic infection among Children in Central Ethiopia Regional State: A Randomized Control Trial
Official scientific title Effectiveness of hygienic practice Intervention on reducing intestinal parasitic infection
Brief summary describing the background and objectives of the trial Intestinal parasitic infections (IPIs) are very common in Ethiopia. It is one of the major public health problems in Ethiopia, with millions of children suffering from these infections and their devastating short- and long-term consequences(Zemene and Shiferaw, 2018; Bisetegn et al., 2023; Lanker et al., 2023). As Ethiopia is located in a tropical region, it is a suitable breeding ground for soil-transmitted helminths and worms(Alemu et al., 2021). What's more, although Ethiopia has many large rivers, the tap water supply is limited to a few large cities, and many areas of the country rely on wells and springs(Alemu, Teklu, and Alemayehu, 2015). These water sources are prone to pollution(Alemu, Teklu and Alemayehu, 2015). Most of the children and caregivers/parents use paper and other leaves of plants for cleaning the perineal area after toilet use. Despite this, there are no comprehensive IPI prevention interventions in Ethiopia. So, the objective of this study is to examine the effectiveness of the hygienic practice Intervention in reducing IPI in children in central Ethiopia's regional state 2025. Hypothesis: HA: A hygienic practice intervention, can significantly reduce the incidence of intestinal parasitic infections among children. A randomized controlled study design will be used to frame this study. A statistically determined and randomly selected 124 (62 in each group) parasite-negative school-age children will be included in this study. The intervention package included the provision of a Jerrycan equipped with a spray pipe made of local materials that could be easily used to clean perennial organs by spraying water after using the toilet. A descriptive statistical procedure and the chi-square (χ²) test will be used to describe the data set and compare the incidence of parasitic infections between the two groups respectively.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Intestinal parasitic infection
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Intestinal parasite infection
Purpose of the trial Education /Training
Anticipated trial start date 30/09/2024
Actual trial start date 17/09/2024
Anticipated date of last follow up 01/09/2025
Actual Last follow-up date 29/09/2025
Anticipated target sample size (number of participants) 124
Actual target sample size (number of participants) 124
Recruitment status Active, not 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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hygienic practice Intervention package Two, before and after intervention after six months six months The intervention package included the provision of a Jerrycan equipped with a spray pipe made of local materials that could be easily used to clean perennial organs by spraying water after using the toilet. Basic information about the prevention of intestinal parasitic infection and details of instructions on how to use the intervention material properly is also included in the intervention package. The laboratory test results and socio-demographic characteristics of each study participant will be collected using a validated tool at baseline, before and after intervention. 62
Control Group No intervention Not applicable six months The usual care , simply follow-up. 62 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School-age children (6 -12 years of age) Both sexes (male and female). Stool exam results show negative for any type of intestinal parasites and worms during the start of the intervention Those who are receiving a similar intervention will be excluded Child: 6 Year-12 Year 6 Year(s) 12 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
No 25/05/2024 Hosanna Health Sciences College institutional review board
Ethics Committee Address
Street address City Postal code Country
Hosanna Hosanna 159 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of intestinal parasitic infection. The outcome will be measured at two time points, before intervention (pre-intervention) and 6 months after intervention (post-intervention). 6 months after intervention
Secondary Outcome The nutritional status of children 6 months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Ethiopia Regional state Gurage, Hadiya, Silte, Kembata , Alaba Zones and Yem special Woreda Hosanna Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hosanna Health Sciences College Hosanna Hosanna Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Hosanna Health Sciences College Hosanna Hosanna Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Likawun Asfaw samuelliku@gmail.com +251911549009 Hosanna
City Postal code Country Position/Affiliation
Hosanna Ethiopia Researcher in Central Ethiopia Regional state
Role Name Email Phone Street address
Public Enquiries Degefe Tadele degefa04@gmail.com +251915671817 Hosanna
City Postal code Country Position/Affiliation
Hosanna Ethiopia Research and Community service directorate director
Role Name Email Phone Street address
Scientific Enquiries Tadese Hamdala thamdalla77@gmail.com +251912152285 Hosanna
City Postal code Country Position/Affiliation
Hosanna Ethiopia College Dean
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the participant data collected during the trial will be shared after de-identification. The informed consent form, the data collection tools, the raw data entered into STATA and the study protocol will be shared immediately following publication. The researchers and interested institutions or individuals can obtain these data directly from the principal investigator. Moreover, the metadata will be submitted to the international journal publishers with the manuscript during the process of evaluation for possible publication. So, interested institutions or individuals can also access it from the publisher's website. Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year Open (Data will be available from the principal investigator upon the acceptable request)
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