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Trial registered on ANZCTR


Registration number
ACTRN12611000906954
Ethics application status
Approved
Date submitted
3/08/2011
Date registered
24/08/2011
Date last updated
24/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a screening and treatment program using oral ivermectin to manage pediculosis capitis (head lice) in primary schools
Scientific title
Does whole of primary school screening for head lice and treatment with oral ivermectin of infested students, their parents and other household members reduce the rate of head lice infestation in the whole school community three months after the intervention?
Secondary ID [1] 262725 0
Not applicable
Universal Trial Number (UTN)
U1111-1123-2785
Trial acronym
CHiPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head lice infestation 270446 0
Condition category
Condition code
Public Health 270593 270593 0 0
Health service research
Skin 270636 270636 0 0
Dermatological conditions
Public Health 270637 270637 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screening intervention
Consented students will be screened for head lice infestation (case definitions = at least 1 live louse or > 12 live lice = hyperinfested)

Parent education intervention (includes a paper based screening tool and head lice comb)
Parents will be provided with an education package designed to provide them with the knowledge and skills to effectively screen their child/ren for head lice. Knowledge acquisition will be assessed pre and post education package using a short quiz. Head lice screening skills will be assessed by comparing the effectiveness of head lice detection by parents compared to trained screeners. Effectiveness is measured by detecting/not detecting head lice and by identifying/not identifying hyperinfestation with head lice.

Treatment intervention
Treatment is oral ivermectin treatment - i.e. Stromectol tablets 200 micrograms per kilogram of body weight up to 18 mgs two doses 7 days apart.
Phase 1
In the first 2 schools students found to be infested/hyperinfested with head lice and their infested/hyperinfested household members will be offered ivermectin tablets free of charge.
Phase 2
In the next 2 schools students found to be infested/hyperinfested with head lice and their infested/hyperinfested household members will be offered a prescription for oral ivermectin and compliance with redeeming the prescription will be monitored using pharmacy records.
Phase 3
In the next 2 schools only hyperinfested students and their infested/hyperinfested household members will be offered oral ivermectin free of charge.
Phase 4
In the final 2 schools students found to be hyperinfested with head lice and their infested/hyperinfested household members will be offered a prescription for oral ivermectin and compliance with redeeming the prescription will be monitored using pharmacy records.
Intervention code [1] 267085 0
Treatment: Drugs
Intervention code [2] 267114 0
Early detection / Screening
Intervention code [3] 267115 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269335 0
The prevalence of head lice infestation in primary schools students infested/hyperinfested with head lice and their infested/hyperinfested household members are treated with oral ivermectin. Outcome is measured by clinical assessment of all consented primary school students by trained head lice screeners in schools where ivermectin treatment has been offered 3 months after treatment.
Timepoint [1] 269335 0
3 months
Secondary outcome [1] 279402 0
Acceptability of oral ivermectin treatment to primary school students, their parents and other household members. Outcome is assessed by administration of questionnaires containing Yes/No and categorical questions - one questionnaire for households where ivermectin was offered free of charge and one questionnaire for households where ivermectin script was offered and households paid for their treatment.
Timepoint [1] 279402 0
14 days and 3 months after treatment
Secondary outcome [2] 279403 0
Effectiveness of parental screening for head lice compared to effectiveness of trained head lice screeners. Effectiveness is measured by detecting/not detecting head lice and by identifying/not identifying hyperinfestation with head lice.
Screening procedure: Parental and trained screeners will use one fine-tooth comb per child. The comb method has been found to be superior to direct visual examination for the detection of head lice with one study finding the average time to first louse detection was 57 seconds with the comb compared to 116 seconds by direct visual examination. This method is not as invasive as combing after applying hair conditioner. All head hair will be combed at least twice, taking approximately 5 minutes per child for short hair and 15 minutes for long hair.
Timepoint [2] 279403 0
Following parent education and student screening by parents and/or student screening by trained screeners prior to treatment and again 3 months after treatment
Secondary outcome [3] 279404 0
The prevalence of head lice infestation in primary schools when only hyperinfested students (> 12 head lice) and their infested household members (at least 1 live louse) are treated with oral ivermectin compared to when all head lice infested students and their infested household members (at least 1 live louse detected) are treated with oral ivermectin. Outcome is assessed by whole of school screening by trained screeners using the combing protocol previously described.
Timepoint [3] 279404 0
3 months

Eligibility
Key inclusion criteria
Consented/consenting Australian Capital Territory primary school students and their household members (screening)

Consented/consenting Australian Capital Territory primary school students and their household members who are infested with head lice (treatment)
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children aged less than 5 years
Children weighing less than 15 kilograms
Pregnant women
Breast feeding women
People reporting allergic reaction or hypersensitivity to ivermectin or any of the components of Stromectol e.g gluten
Students who do not verbally ASSENT to participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents and students from 8 primary schools will be invited to participate in the study (screening) by letter.

Infested students and infested household members will receive oral ivermectin if they consent following a medical consultation (written for children aged less than 16 years, oral for adults)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The principal aim of this study is to obtain information that will enable the development of an effective sustainable head lice education, screening and treatment program suitable for implementation in all primary schools.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267557 0
University
Name [1] 267557 0
Australian National University
Country [1] 267557 0
Australia
Funding source category [2] 269595 0
University
Name [2] 269595 0
The Australian National University
Country [2] 269595 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Academic Unit of Internal Medicine
Building 4, Level 2
Canberra Hospital
PO Box 11
Woden
ACT 2606
Country
Australia
Secondary sponsor category [1] 266593 0
None
Name [1] 266593 0
Address [1] 266593 0
Country [1] 266593 0
Other collaborator category [1] 252161 0
University
Name [1] 252161 0
University of Canberra
Address [1] 252161 0
Discipline of Pharmacy
Faculty of Health
Bruce
ACT 2601
Country [1] 252161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269518 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 269518 0
Building 10, Level 6
Canberra Hospital
PO Box 11
Woden
ACT 2606
Ethics committee country [1] 269518 0
Australia
Date submitted for ethics approval [1] 269518 0
23/05/2011
Approval date [1] 269518 0
22/06/2011
Ethics approval number [1] 269518 0
ETH.5.11.101
Ethics committee name [2] 269546 0
The Australian National University Human Research Ethics Commitee
Ethics committee address [2] 269546 0
Research Office
Lower Ground Floor
Chancelry 10B
East Road
Australian National University
Acton ACT 0200
Ethics committee country [2] 269546 0
Australia
Date submitted for ethics approval [2] 269546 0
03/08/2011
Approval date [2] 269546 0
04/08/2011
Ethics approval number [2] 269546 0
EC00104
Ethics committee name [3] 271697 0
University of Canberra Human Research Ethics Committee
Ethics committee address [3] 271697 0
Research Services Office (Room: 1 D 116)
Building 1
University of Canberra
Kirinari Street
Bruce ACT 2617
Ethics committee country [3] 271697 0
Australia
Date submitted for ethics approval [3] 271697 0
08/08/2011
Approval date [3] 271697 0
19/08/2011
Ethics approval number [3] 271697 0
EC00108

Summary
Brief summary
The principal aim of this study is to obtain information that will enable the development of an effective sustainable head lice education, screening and treatment program suitable for implementation in all primary schools. The proposed study builds on the results of a pilot study we conducted in 2008 where we tested the feasibility and acceptability of whole-school head lice screening and the use of oral ivermectin as a treatment for head lice among those found to be infested. As screening hundreds of students is time consuming and therefore expensive and the provision of oral ivermectin free of charge to the consumer is also expensive the proposed study is designed to identify a more efficient approach.

The specific objectives of the proposed study are to determine if (1) parents/guardians (hereafter parent(s)) are as efficient at identifying head lice as trained screeners, (2) if oral ivermectin is an acceptable treatment for head lice in primary school children and their household members and (3) the most acceptable way to provide oral ivermectin treatment for head lice. An instrument to enable parents to screen their children for head lice has been developed and will be tested and validated; the acceptability of oral ivermectin, provided in three ways (free of charge to all infested students and their infested household members, through user pays prescription to all infested students and their infested household members and free of charge only to hyper-infested students and their infested household members (infested with more than 12 lice), will be ascertained using questionnaires, uptake of ivermectin and telephone contact (acceptability) and rescreening of infested and treated students (effectiveness)
Trial website
Under development
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32943 0
Address 32943 0
Country 32943 0
Phone 32943 0
Fax 32943 0
Email 32943 0
Contact person for public queries
Name 16190 0
Marian Currie
Address 16190 0
Academic Unit of Internal Medicine
Canberra Hospital
PO Box 11
Woden
ACT 2606
Country 16190 0
Australia
Phone 16190 0
61 2 6244 3791
Fax 16190 0
61 2 6244 4964
Email 16190 0
[email protected]
Contact person for scientific queries
Name 7118 0
Marian Currie
Address 7118 0
Academic Unit of Internal Medicine
Canberra Hospital
PO Box 11
Woden
ACT 2606
Country 7118 0
Australia
Phone 7118 0
61 2 6244 3791
Fax 7118 0
61 2 6244 4964
Email 7118 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.