Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000322336
Ethics application status
Approved
Date submitted
23/06/2008
Date registered
14/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preference and acceptability study of long-lasting insecticidal nets (LLINs) in Solomon Islands.
Scientific title
A combined qualitative and quantitative study to determine population preference and acceptability of long-lasting insecticidal bed nets (LLINs) for malaria prevention in Solomon Islands.
Secondary ID [1] 600 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preference and acceptability of long-lasting insecticidal bed nets for malaria prevention 3298 0
Condition category
Condition code
Public Health 3460 3460 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three brands of Long-lasting Insecticidal nets (LLINs) will be trialed and assessed for their acceptability among a randomly selected sample of households in Malaita Province, Solomon Islands. Randomly selected villages be cluster randomized to one of the 6 bed net assessment groups. Each bed net assessment group will be assigned 2 brands of long lasting insecticidal bed nets (cross-over design) to trial. Each household will trial the 2 different brands of bed nets assigned to their group for approx 10 days each, then the second brand of net trialed will be continued for a further 3 weeks. As this is an acceptability and preference study, no wash-out period was deemed necessary.
STUDY DESIGN OUTLINE:
Group 1 - to trial Olyset then PermaNet nets
Group 2 - to trial PermaNet then Olyset nets
Group 3 - to trial Olyset then DuraNet nets
Group 4 - to trial DuraNet then Olyset nets
Group 5 - to trial PermaNet then DuraNet
Group 6 - to trial DuraNet then PermaNet
Intervention code [1] 3037 0
Other interventions
Comparator / control treatment
No control group: Three brands of Long-lasting Insecticidal nets are used in the study and no particular brand acts as a control group.
Control group
Active

Outcomes
Primary outcome [1] 4358 0
Primary Outcome 1: Acceptability of bed net trialed. This will be assessed using a pre-determined Acceptability survey (informed by a previous qualitative investigation into bed net acceptability and preference)
Timepoint [1] 4358 0
Timepoint: 10 days after the start of the trial of each brand of bed net.
Secondary outcome [1] 7344 0
Secondary Outcome: Preference for one of the 2 nets trialed. This will be assessed using a pre-determined Preference Questionnaire (informed by a previous qualitative investigation into bed net acceptability and preference)
Timepoint [1] 7344 0
Timepoint: At 20 days (at completion of trial of both brands of net) and again 3 weeks following the first preference quesionnaire.

Eligibility
Key inclusion criteria
Be a head of the household or primary caregiver
Be capable of giving informed consent for all members of the household to participate in the acceptability surveys and preference questionnaire.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Are likely to be absent from the household during the study period.
Would be unable or unlikely to comply with the study protocol
Have had a previous adverse reaction to the use of LLINs other than those that were minor and transient.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to Intervention: Off-site random allocation was carried out using Excel random number allocation function and satellite imagery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study population will consist of heads of households and primary care-givers. Three stage sampling will be used to select the study population. In the first stage, 6 villages in Malaita province, SI, will be randomly selected from a list of villages (with a population > 200 people) using an Excel generated random numbering system. In the second stage, the selected villages will be cluster randomized to one of the 6 bed net assessment groups. Finally, natural clusters of households within each selected village (at least 20 households per cluster) will be identified and one cluster randomly selected within each village to be invited to participate in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 1005 0
Solomon Islands
State/province [1] 1005 0
Malaita Province

Funding & Sponsors
Funding source category [1] 3506 0
University
Name [1] 3506 0
Pacific Malaria Initiative Support Centre
Country [1] 3506 0
Australia
Primary sponsor type
University
Name
Pacific Malaria Initiative Support Centre
Address
Level 4
Public Health Building
School of Population Health
University of Queensland
Herston Rd,
Herston, QLD, 4006
Country
Australia
Secondary sponsor category [1] 3148 0
Government body
Name [1] 3148 0
Vector Borne Disease Control Program
Address [1] 3148 0
SIMTRI Building
Kukum Rd,
Kukum, Honiara
Country [1] 3148 0
Solomon Islands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5543 0
HREC, University of Queensland
Ethics committee address [1] 5543 0
Ethics committee country [1] 5543 0
Australia
Date submitted for ethics approval [1] 5543 0
Approval date [1] 5543 0
30/04/2008
Ethics approval number [1] 5543 0
2008000532

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28692 0
Address 28692 0
Country 28692 0
Phone 28692 0
Fax 28692 0
Email 28692 0
Contact person for public queries
Name 11849 0
Jo-An Atkinson
Address 11849 0
Level 4
Public Health Building
School of Population Health
University of Queensland
Herston Rd,
Herston, QLD, 4006
Country 11849 0
Australia
Phone 11849 0
+61 (0) 407033766
Fax 11849 0
+61 (0)7 3365 5599
Email 11849 0
[email protected]
Contact person for scientific queries
Name 2777 0
Dr Andrew Vallely
Address 2777 0
Level 4
Public Health Building
School of Population Health
University of Queensland
Herston Rd,
Herston, QLD, 4006
Country 2777 0
Australia
Phone 2777 0
+61 (0)7 3346 4970
Fax 2777 0
+61 (0)7 3365 5599
Email 2777 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.