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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: www.pactr.org

Trial no.: PACTR201206000387125 Date registered: 2012/05/31
TRIAL DESCRIPTION
Public title Hand hygiene
Official scientific title Effect of alcohol-based hand rub use by home-based caregivers on child health in a rural informal settlement: a double blinded randomised controlled trial
Brief summary describing the background
and objectives of the trial
Trial in hand hygiene by using hand rubs to determine the effect it has on the incidence of acute respiratory infections and diarrhoea of children under 5 years.Pre- and-post experimental assessment of hand hygiene knowledge and current practices amongst the home-based caregivers,implementation of hand hygiene promotion in the form of an educational programme with the use of an alcohol-based hand rub.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2012-05-21
Actual trial start date 2012-05-21
Anticipated date of last follow up 2012-07-25
Actual date of last follow up
Anticipated target sample size (number of participants) 112   
Actual target sample size (number of participants) 140   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
N11/11/319 Health Research Ethics Committee
N11/11/319 Health Research Ethics Committee

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 Every second clinic attendee was sampled if they fit the inclusion criteria and included in the study if they agreed to participate Participants were given the same interventions aside from hand rubs - hand rubs were bar coded externally, and the person providing the hand rubs was blind to their difference Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Hand hygiene promotion experiment 6 months education, questionnaire and hand rub 70 Active
Control group Control group - hand hygiene placebo 6 months education, questionnaire and placebo hand rub 70 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Adult home-based caregivers (parent and main caregivers aged 18 years and above of children attending Phola Park who are: a) under 5 years of age b) Living in Phola Park c) Planning to continue residing in Phola Park for the duration of the study Adult home-based caregivers of children under 5 years of age who are: a) Being treated for diarrhoea and respiratory infections b) Placed in custody because the biological parent could not care for them 1 Day 5 Years 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
Yes Health Research Etics Committee
Ethics Committee Address
Street address City Postal code Country
POBox 19063 Tygerberg 7505 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess whether knowledge and practices of hand hygiene among the home-based caregivers have changed six months after the implementation of the intervention. End of July 2012
Primary Outcome To assess the hand hygiene knowledge and application thereof by the main home-based caregivers of children under 5 years. End of July 2012
Primary Outcome To determine whether the outcome differs between the control and study group. End of July 2012

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Phola Park Clinic Bukanani street Paarl 7655 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
PNMedical South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PNMedical 5 Van der Bergstreet Strand 7140 South Africa Company

COLLABORATORS
Name Street address City Postal code Country
Sr Barties Bukanani street Wellington 7655 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Mrs Joelynn Geraldine Rachelle Steyn joelynnsteyn@mweb.co.za 0797102735 (021) 8681484
Street address City Postal code Country Position / Affiliation
6 Montmartre street, Klein Parys Paarl 7655 South Africa colleagues
Role Name Email Phone Fax
Scientific Enquiries Dr Frederick Marais maraisfck@sun.ac.za (021) 9385053
Street address City Postal code Country Position / Affiliation
Tygerberg Hospital Tygerberg 7499 South Africa mentor
Role Name Email Phone Fax
Public Enquiries Mrs Cathleen Solomons clsolomon@pgwc.gov.za (o21) 8624520
Street address City Postal code Country Position / Affiliation
TC Newman Paarl 7655 South Africa Area Manager