Clinical trial NCT01619254: Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Parasitic Infections
Anaemia
Keywords: Intestinal parasitic infections
Anaemia
School-aged children
Hand washing and nail clipping
Lead sponsor: Mekelle University
Sponsor class: OTHER
Collaborators: name: University of Alcala
name: Maastricht University
First posted: 2012-06-14
Enrollment: 365
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: - Proportion of intestinal parasitic re-infection rates among intervention and control groups
timeFrame: six months
measure: - Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups
timeFrame: six months
Secondary outcomes:
measure: Proportion of anaemia prevalence rates among intervention and control groups
timeFrame: six months
Other outcomes:
Locations:
city: Mekelle
country: Ethiopia
facility: College of Health Sciences, Mekelle University
state: Tigray
Study officials:
affiliation: College of Health Scieneces, Mekelle University
name: Mahmud Ab Mahmud, PhD fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Alcala University, Madrid, Spain
name: Roman B Velasco, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University, The Netherlands
name: Mark Spigt, MSC, PhD
role: STUDY_CHAIR
affiliation: College of Health Sciences, Mekelle University
name: Afework M Bezabeh, MSC, PhD
role: STUDY_CHAIR
affiliation: Maastricht University, The Netherlands
name: Geert J Dinant, Professor
role: STUDY_CHAIR
References:
citation: 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.