Condition category
Infections and Infestations
Date applied
09/06/2017
Date assigned
21/06/2017
Last edited
21/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
Parasitic worms (helmiths) are organisms that live in the intestine and feed off their living hosts. They are among the most common type of infections worldwide, especially in poor and deprived communities. They are spread by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor. An infection can cause malnutrition, physical and mental retardation, and reduced work performance in older age. Previous surveys undertaking in the Kagera Region of Tanzania have found that more than 70% of primary school children aged 6 – 12 years in some schools suffer from parasitic worm infections. This is also the case in other parts of Tanzania (and other resource-limited countries) in spite of annual deworming campaigns that are conducted in schools by the national control programme for neglected tropical diseases. Deworming campaigns remain a cost-effective way to treat these infections, but they do not target the route cause and so many experience repeated infections. An integrated approach that combines deworming with sustainable hygiene behaviour change could prove an effective way to control parasitic worm infections. The aim of this study is to find out whether the effects of routine deworming campaigns in primary schools in Africa can be enhanced and sustained by combining it with an appropriate Water, Sanitation and Hygiene (WASH) behaviour change program to improve hand-washing practices.

Who can participate?
Primary school aged children attending participating primary schools.

What does the study involve?
Participating schools are randomly allocated to one of two groups. At the start of the study, children attending schools in both groups undergo annual deworming using deworming medication. Schools in the first group then continue as normal. Schools in the second group take part in the behaviour change program. This involves teacher-led health education in primary schools, low-cost structural improvements of water supply and sanitation (e.g. soap dispensers), nudges to increase students intention to wash hands after defecation (e.g. painted footpaths that connect toilets with hand-wash stations), and a one-off screening of students for current worm infection combined with feedback of results to parents and health information given to students’ parents (with the intention to increase parents’ awareness and concern). One year after enrolment, all students complete a follow-up survey to see if they are infected with worms.

What are the possible benefits and risks of participating?
Participants may benefit from increased knowledge and skills on hand-washnig behaviour, preventing them from bacterial infections. Treatment with albendazole may improve the general health status of children, reduce potential aneaemia and improve their cognitive (mental) capacity. There are no notable risks however, treatment with albendazole may cause temporary nausea and questions on hygiene may be perceived as sensitive or embarrassing.

Where is the study run from?
The study is run from Mwanza Intervention Trials Unit and takes place in 16 primary schools in the Kagera Region (Tanzania)

When is study starting and how long is it expected to run for?
October 2016 to December 2018

Who is funding the study?
Department for International Development (UK)

Who is the main contact?
1. Professor Heiner Grosskurth (scientific)
2. Professor Saidi Kapiga (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heiner Grosskurth

ORCID ID

http://orcid.org/0000-0001-9960-7280

Contact details

PO 11936
Mwanza
-
Tanzania

Type

Scientific

Additional contact

Prof Saidi Kapiga

ORCID ID

Contact details

Mwanza Intervention Trials Unit (MITU)
National Institute for Medical Research
Mwanza Centre (NIMR Mwanza)
Isamilo Road
PO 11936
Mwanza
-
Tanzania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

Cluster-randomised controlled trial to evaluate the effectiveness of an intervention for improving handwashing behaviour on the prevalence of soil transmitted helminth infections among primary school children in NW Tanzania

Acronym

Mikono Safi Study

Study hypothesis

Among children with a high prevalence of soil transmitted helminth infections in-spite of annual deworming, a hand washing intervention will be effective in reducing the prevalence and intensity of Ascaris lumbricoides and Trichuris trichiura infections.

Ethics approval

1. Medical Research Coordinating Committee (MRCC), National Institute for Medical Research,18/05/2017, ref: Nu NIMR/HQ/R.8a/Vol. IX/2497
2. Ethics Committee of the London School of Hygiene and Tropical Medicine, ref: 11868

Study design

Open-label single-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

1. Soil transmitted helminth infections
2. Water, sanitation and hygiene (WASH) related behaviour

Intervention

Participanting schools are randomised within geographical strata (districts). There are three districts (Bukoba Urban District, Bukoba Rural District and Muleeba District). Randomisation to either the intervention or control arm is done through a computer generator.
Both intervention and control arm schools participate in an annual deworming campaign, timed to start just before the intervention. Deworming is done with single dose Albendazole (400 mg orally). Following deworming with Albendazole in both arms of the study, students will participate in a baseline survey involving a stool examination to determine whether they have a helminth infection. Those still infected will be immediately re-treated with Albendazole

Intervention arm: Schools participants in a combination intervention with 4 components:
1. Teacher-led health education delivered in 3 sessions of about 2 hours each, over a period of 9 months
2. Low-cost structural improvements with respect to water supply and sanitation (e.g. continuous provision of hand wash stations and soap dispensers)
3. Nudges to increase students intention to wash hands after defecation (colour painted footpaths)
4. One-time screening of students for current worm infection at beginning of intervention, combined with feedback of results to parents and health information given to students’ parents.
Participants in this arm receive a behavioural intervention after this to improve their hand washing behaviour.

Control arm: Schools continue with business as usual.

One year after enrollment, participants in both arms complete a follow-up survey to determine whether they are infected or reinfected. Reinfected students are treated again.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Combined prevalence of ascariasis and trichuriasis in students’ stool samples is measured by microscopy using the formol-ether concentration method to identify helminth ova, at baseline and about 12 months after initial deworming.

Secondary outcome measures

1. Hand-washing behaviour in schools (reported and observed) and at home (reported only) by administering structured questionnaires and records respectively at baseline and 12 months after deworming
2. Intensity (worm egg count) of ascariasis and trichuriasis infections is measured by microscopy, counting helminth ova in samples of about 2 grams, at baseline and 12 months after deworming
3. Levels of hand contamination with worm eggs and E. coli bacteria is measured by a previously validated concentration procedure and microscopy, applied to hand-rinse samples, obtained at 12 months after deworming
4. Prevalence and intensity of hookworm infection is measured by microscopy at baseline and 12 months after deworming

Overall trial start date

01/10/2016

Overall trial end date

20/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary school students
2. Male and female
3. Attending classes 1 - 6
4. aged 6 - 12 years

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

16 clusters (primary schools) with 200 participants per school; 3200 children in total

Participant exclusion criteria

1. Student not giving assent
2. Parent or guardian refusing consent

Recruitment start date

01/08/2017

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Tanzania

Trial participating centre

Mwanza Intervention Trials Unit (MITU)
National Institute for Medical Research Tanzania Mwanza Centre Isamilo Road
Mwanza
-
Tanzania

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (LSHTM)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

https://www.lshtm.ac.uk/

Funders

Funder type

Government

Funder name

Department for International Development, UK Government

Alternative name(s)

Department for International Development, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of the results of the trial in a high-impact peer reviewed journal by or before December 2019. We also intend to issue policy briefs by about June 2019.

IPD sharing statement:
The datasets generated during the current study will be made available upon request from the PI Prof Saidi Kapiga (saidi.kapiga@lshtm.ac.uk), following approval from the Trial Steering Committee (TSC) and after the MITU research team has had an opportunity to publish the results of the trial, but latest within 2 years of the end of data collection (which is expected for December 2018 at the latest).

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes