Intestinal Parasitic InfectionsNCT01619254
Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children
A study testing Hand washing with soap and hand finger nail clipping in people with Intestinal Parasitic Infections and Anaemia, run by Mekelle University at 1 site in Ethiopia.
Trial summary
Impact exerted by intestinal parasitic infections is much higher in developing countries. School-aged children are at higher risk from the burden of disease, because they specially have many parasitic infections. The poor health results in deficits in physical and cognitive development and educational achievements. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Parasitic Infections, Anaemia
- What is being tested?
- Hand washing with soap and hand finger nail clipping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 1 siteEthiopia
- Study dates
- Jul 2012to Feb 2013
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- households and children who will give a written consent to participate in the study
- households and children who are going to stay in the area throughout the study period
- children aged 6 to 15
Who cannot join
- households and children who able to produce a written consent
- children who are under treatment
- children with age less than 6 and greater than 15 years
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
College of Health Sciences, Mekelle University
Mek'ele, Tigray
About this study
Official title: Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial
Impact exerted by intestinal parasitic infections is much higher in developing countries. School-aged children are at higher risk from the burden of disease, because they specially have many parasitic infections. The poor health results in deficits in physical and cognitive development and educational achievements. Nowadays, there is huge commitment among the global community to control intestinal parasitic infections and to improve nutritional status of young children in developing countries.
Large-scale anthelminthic drug administration through vertical control programmes is still required for the foreseeable future and is, therefore, recommended by the World Health Organization (WHO). However, due to the inevitability of re-infection in endemic areas, children need to be treated regularly, and once morbidity control is consolidated, the strategy must shift to transmission control emphasising access to clean water and adequate sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from the onset of control activities, complementary measures should be implemented, that depend on available resources.
Therefore, the investigators are proposing to undertake a randomised controlled trial to assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing with soap and hand finger nail clipping) on intestinal parasitic infection prevalence, intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and how hand hygiene practice affects infection prevalence and re-infection rates, as well as, anaemia prevalence among the highly vulnerable age group.
Read the detailed description
The controlled prospective cohort study will be carried out in Kilte awlaelo wereda, north Ethiopia. A total of 216 households with at least one school-aged child (aged 6-15) will be randomly selected by systematic random sampling method. Different intervention packages will be randomised among households. Intervention activities will be implemented at household level, using the selected child within the household as study unit.
If there are more than one child per randomised household all children will receive the intervention, but only two children, selected by simple random selection method, will be included in the trial. Selected children will be screened for intestinal parasitosis, following acquisition of signed informed consent, and will be recruited for the study after treatment.
Parasite negative children in the respective households will be randomly allocated into intervention and control groups. Sequence allocation will be done in a central office by an individual who do not know and have no contact with the study sites and households.
Each intervention and control group will have a fixed number of participants, and will be subjected to only one of the study interventions. Children and households in each group will be followed-up for 6 months by trained fieldworkers and the investigators according to a developed protocol throughout the study period. Parasitological, haemoglobin and anthropometric data will be collected at entry and after six months.
- Conditions
- Intestinal Parasitic Infections, Anaemia
- Being tested
- Hand washing with soap and hand finger nail clipping
- Keywords
- Intestinal parasitic infections, Anaemia, School-aged children, Hand washing and nail clipping
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand washing with soap and hand finger nail clippingBehavioural
Also called Hand washing and finger nails clipping
Assess the impact of hand washing with soap and nail clipping on child health
| Study group | Role | What they receive |
|---|---|---|
| Hand hygiene | Experimental | Hand washing with soap measures will be carried out as an intervention activity Receives: Behavioral: Hand washing with soap and hand finger nail clipping |
| Hand finger nail hygiene | Experimental | Hand finger nail clipping activities Receives: Behavioral: Hand washing with soap and hand finger nail clipping |
| Hand and finger nails hygiene | Experimental | Both hand washing with soap and hand finger nail clipping activities will be implemented Receives: Behavioral: Hand washing with soap and hand finger nail clipping |
| Customary practice | Placebo comparator | No hand washing with soap and nail clipping activities. House holds and children assigned to the control group will not have the interventions (hand washing with soap and nail clipping activities) Receives: Behavioral: Hand washing with soap and hand finger nail clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Proportion of intestinal parasitic re-infection rates among intervention and control groups
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic re-infection prevalence will be assessed.
Measured: six months
- Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.
Measured: six months
Secondary outcomes (1)
Proportion of anaemia prevalence rates among intervention and control groups
Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal Parasitic InfectionsStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mekelle University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, Maastricht University
- Responsible party
- Principal investigator, Mahmud Abdulkader, Mekelle University
- Investigators
- Mahmud Ab Mahmud, PhD fellow, Principal investigator, College of Health Scieneces, Mekelle UniversityRoman B Velasco, MD, PhD, Study director, Alcala University, Madrid, SpainMark Spigt, MSC, PhD, Study chair, Maastricht University, The NetherlandsAfework M Bezabeh, MSC, PhD, Study chair, College of Health Sciences, Mekelle UniversityGeert J Dinant, Professor, Study chair, Maastricht University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619254
- Sponsor's protocol ID
- AECID
- Status last verified
- Jan 2015
- First submitted
- 9 Jun 2012
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahmud MA, Spigt M, Bezabih AM, Dinant GJ, Velasco RB. Associations between intestinal parasitic infections, anaemia, and diarrhoea among school aged children, and the impact of hand-washing and nail clipping. BMC Res Notes. 2020 Jan 2;13(1):1. doi: 10.1186/s13104-019-4871-2.
PubMed 31898526
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01619254
- Acronym / sponsor ID
- AECID
- Conditions
- Intestinal Parasitic Infections, Anaemia
- Keywords
- Intestinal parasitic infections, Anaemia, School-aged children, Hand washing and nail clipping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Mekelle UniversityUniversity, hospital or other
- Collaborators
- University of Alcala, Maastricht University
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jun 2012 (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.
Impact exerted by intestinal parasitic infections is much higher in developing countries. School-aged children are at higher risk from the burden of disease, because they specially have many parasitic infections. The poor health results in deficits in physical and cognitive development and educational achievements. Nowadays, there is huge commitment among the global community to control intestinal parasitic infections and to improve nutritional status of young children in developing countries.
Large-scale anthelminthic drug administration through vertical control programmes is still required for the foreseeable future and is, therefore, recommended by the World Health Organization (WHO). However, due to the inevitability of re-infection in endemic areas, children need to be treated regularly, and once morbidity control is consolidated, the strategy must shift to transmission control emphasising access to clean water and adequate sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from the onset of control activities, complementary measures should be implemented, that depend on available resources.
Therefore, the investigators are proposing to undertake a randomised controlled trial to assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing with soap and hand finger nail clipping) on intestinal parasitic infection prevalence, intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and how hand hygiene practice affects infection prevalence and re-infection rates, as well as, anaemia prevalence among the highly vulnerable age group.
Detailed description
The controlled prospective cohort study will be carried out in Kilte awlaelo wereda, north Ethiopia. A total of 216 households with at least one school-aged child (aged 6-15) will be randomly selected by systematic random sampling method. Different intervention packages will be randomised among households. Intervention activities will be implemented at household level, using the selected child within the household as study unit.
If there are more than one child per randomised household all children will receive the intervention, but only two children, selected by simple random selection method, will be included in the trial. Selected children will be screened for intestinal parasitosis, following acquisition of signed informed consent, and will be recruited for the study after treatment.
Parasite negative children in the respective households will be randomly allocated into intervention and control groups. Sequence allocation will be done in a central office by an individual who do not know and have no contact with the study sites and households.
Each intervention and control group will have a fixed number of participants, and will be subjected to only one of the study interventions. Children and households in each group will be followed-up for 6 months by trained fieldworkers and the investigators according to a developed protocol throughout the study period. Parasitological, haemoglobin and anthropometric data will be collected at entry and after six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hand hygiene | Experimental | Behavioral: Hand washing with soap and hand finger nail clippingHand washing with soap measures will be carried out as an intervention activity |
| Hand finger nail hygiene | Experimental | Behavioral: Hand washing with soap and hand finger nail clippingHand finger nail clipping activities |
| Hand and finger nails hygiene | Experimental | Behavioral: Hand washing with soap and hand finger nail clippingBoth hand washing with soap and hand finger nail clipping activities will be implemented |
| Customary practice | Placebo comparator | Behavioral: Hand washing with soap and hand finger nail clippingNo hand washing with soap and nail clipping activities. House holds and children assigned to the control group will not have the interventions (hand washing with soap and nail clipping activities) |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- households and children who will give a written consent to participate in the study
- households and children who are going to stay in the area throughout the study period
- children aged 6 to 15
Key exclusion criteria (3 listed)
- households and children who able to produce a written consent
- children who are under treatment
- children with age less than 6 and greater than 15 years
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 |
|---|---|---|
| Hand washing with soap and hand finger nail clippingAlso: Hand washing and finger nails clippingAssess the impact of hand washing with soap and nail clipping on child health | Behavioural | Customary practice, Hand and finger nails hygiene, Hand finger nail hygiene, Hand hygiene |
Primary outcome
- Proportion of intestinal parasitic re-infection rates among intervention and control groups
Time frame: six months
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic re-infection prevalence will be assessed.
- Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups
Time frame: six months
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.
1 secondary outcome
Proportion of anaemia prevalence rates among intervention and control groups
Time frame: six 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 3 Feb 2015.
- Derived from this study: PubMed 31898526Mahmud MA, Spigt M, Bezabih AM, Dinant GJ, Velasco RB. Associations between intestinal parasitic infections, anaemia, and diarrhoea among school aged children, and the impact of hand-washing and nail clipping. BMC Res Notes. 2020 Jan 2;13(1):1. doi: 10.1186/s13104-019-4871-2.
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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.
Mahmud Ab Mahmud, PhD fellow principal investigator
College of Health Scieneces, Mekelle University
Roman B Velasco, MD, PhD study director
Alcala University, Madrid, Spain
Mark Spigt, MSC, PhD study chair
Maastricht University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand washing with soap and hand finger nail clipping in people with Intestinal Parasitic Infections and Anaemia, run by Mekelle University 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 3 inclusion and 3 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 3 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
- Proportion of intestinal parasitic re-infection rates among intervention and control groups (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619254, which also lists 1 linked publication.
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 3 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.