None listed
Conditions
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)
Interventions
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
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.
Sponsors
Australian National University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 65 Years
Healthy volunteers
Yes
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)
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
Outcome results
None listed