Mikono Safi Study - Hand hygiene intervention to optimise helminthic infections control: a cluster-randomised controlled trial in NW Tanzania

Not Applicable

Completed

• Conditions: 1. Soil transmitted helminth infections 2. Water, sanitation and hygiene (WASH) related behaviour; Infections and Infestations

• Registration Number: ISRCTN45013173
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine (LSHTM)

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31784435/ Qualitative results on facilitators and barriers to hand hygiene (added 26/11/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33296365/ design and baseline characteristics (added 23/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34016091/ (added 24/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-21
• Study Completion: 2019-05-17
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3163

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 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<br> 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<br> 4. Prevalence and intensity of hookworm infection is measured by microscopy at baseline and 12 months after deworming<br>