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Trial registered on ANZCTR


Registration number
ACTRN12615000432516
Ethics application status
Approved
Date submitted
30/03/2015
Date registered
6/05/2015
Date last updated
27/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preference and acceptability of insecticide-treated clothing (ITC) for malaria prevention among rubber tappers in Myanmar
Scientific title
A cluster-randomized, non-inferiority, crossover trial to determine population preference and acceptability of permethrin insecticide-treated clothing (ITC) for malaria prevention among rubber tappers in Myanmar
Secondary ID [1] 286442 0
Nil
Universal Trial Number (UTN)
Trial acronym
MOTIve (Mekong Outdoor Transmission Initiative)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria prevention 294613 0
Condition category
Condition code
Public Health 294916 294916 0 0
Other public health
Infection 295102 295102 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Permethrin insecticide-treated (ITC) and non-treated clothing (NTC) will be trialled and assessed for their acceptability among a randomly selected sample of rubber tappers in Mon State, Myanmar.

The ITC and NTC both consist of a long-sleeved cotton shirt and long cotton pants purchased from a local market vendor in Myanmar. The ITC has been treated with a long-lasting permethrin formulation using a factory proprietary method in China. The NTC is untreated but otherwise identical to the ITC. The clothing is intended to be worn by the rubber tappers during their nighttime work, for approximately 10-12 hours per day. The clothing is washable and all enrolled participants will receive care instructions and a calendar on which to record the days they wash the clothing.

Randomly selected rubber tappers will be cluster randomized to one of the two assessment groups – Arms 1 and 2. Each arm will be assigned ITC and NTC in a crossover design to trial.

Each rubber tapper will trial the two different clothing types assigned to their group for approximately 14 days each. Then, the second clothing type trialled will be continued for a further 6 weeks, that is- participants in Arms 1 and 2 will continue with NTC and ITC, respectively, for six weeks after four weeks of wearing both types of clothing.

As this is an acceptability and preference study, no wash-out period was deemed necessary.

STUDY DESIGN OUTLINE:
Arm 1 - to trial ITC then NTC
Arm 2 - to trial NTC then ITC
Intervention code [1] 291516 0
Prevention
Intervention code [2] 291517 0
Behaviour
Comparator / control treatment
Untreated clothing (long sleeved shirt and long pants).

No control group: Two types of insecticidal clothing are used in the study and no particular type acts as a control group.
Control group
Active

Outcomes
Primary outcome [1] 294669 0
Acceptability of treated clothing trialled. This will be assessed using a pre-determined quantitative acceptability survey that was designed specifically for this study (informed by a previous qualitative investigation into bed net acceptability and preferences).
Timepoint [1] 294669 0
14 days after the start of the trial of each type of treated or non-treated clothing (first follow-up), 14 days after the crossover (second follow-up) and again 6 weeks later (third follow-up).
Secondary outcome [1] 313839 0
Preference for one of the two types of clothing trialled. This will be assessed using a pre-determined quantitative preference questionnaire that was designed specifically for this study (informed by a previous qualitative investigation into distributed clothing acceptability and preference)
Timepoint [1] 313839 0
14 days after the start of the trial of each type of treated or non-treated clothing (first follow-up), 14 days after the crossover (second follow-up) and again 6 weeks later (third follow-up).

Eligibility
Key inclusion criteria
Adult (greater than or equal to 18 years.)
Head of the household and/or a fulltime rubber tapper.
Capable of giving informed consent to participate in the study.
Resident in the study area for at least 5 months from enrollment (until May 2015).
Minimum age
18 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 plantation during the study period.
Would be unable or unlikely to comply with the study protocol.
History of skin allergy or eczema, or have had a previous adverse reaction to the use of treated bednets other than those that were minor and transient.
Currently pregnant or breastfeeding.

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)
Off-site random allocation was carried out using Excel random number allocation function and sketch maps.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study population consists of heads of households and/or full-time rubber tappers. Two stage sampling was used to select the study population. In the first stage, plantations in 2 catchment areas in Mon state, Myanmar, were purposively selected from a list of plantations (with a population <60 people). In the second stage, the selected plantations were cluster randomized to one of the two clothing assessment groups. Finally, natural clusters of households within each selected plantation (at least 8 households per cluster) were identified, with one or more clusters randomly selected within each plantation invited to participate in the study, for a total of 16 clusters (8 per arm). Rubber tappers were randomly selected from a population list using an Excel generated random numbering system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The number of participants per cluster was determined using probability proportionate to size (PPS) sampling but also maintained a minimum of 6 clusters per arm containing at least 12 participants (in order to have >80% power to reject a null hypothesis assuming intra class correlation coefficient due to clustering of individuals is 0.002 and an alpha of 0.05).

A statistical model will be used to analyze the acceptability and preference of the clothing trialed with appropriate adjustment for a cross-over design using STATA. Quantitative analysis will include current and past ITC use and acceptability.

Qualitative analysis of FGD transcripts will be performed manually using content analysis to identify overarching themes and issues relating to preferences and acceptability of the distributed clothing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2015
Actual
10/02/2015
Date of last participant enrolment
Anticipated
13/02/2015
Actual
13/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
234
Recruitment outside Australia
Country [1] 6782 0
Myanmar
State/province [1] 6782 0
Mon State

Funding & Sponsors
Funding source category [1] 291010 0
Charities/Societies/Foundations
Name [1] 291010 0
Department for International Development (DFID)
Country [1] 291010 0
United Kingdom
Funding source category [2] 291011 0
Charities/Societies/Foundations
Name [2] 291011 0
President's Malaria Initiative (PMI)
Country [2] 291011 0
Thailand
Primary sponsor type
Charities/Societies/Foundations
Name
Department for International Development (DFID)
Address
Department for International Development (DFID), 22 Whitehall, London, SW1A 2EG, England
Country
United Kingdom
Secondary sponsor category [1] 289687 0
Charities/Societies/Foundations
Name [1] 289687 0
President's Malaria Initiative (PMI)
Address [1] 289687 0
President's Malaria Initiative (PMI), Greater Mekong Subregion
U.S. Agency for International Development/ Regional Development Mission Asia
Athenee Tower, 25th Floor, 63 Wireless Road, Bangkok 10330, Thailand
Country [1] 289687 0
Thailand
Other collaborator category [1] 278410 0
Government body
Name [1] 278410 0
Department of Medical Research - Lower Yangon
Address [1] 278410 0
No.5 Ziwaka Road, Dagon Township, Yangon 11191, Myanmar.
Country [1] 278410 0
Myanmar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292595 0
Institutional Ethics Review Committee, Department of Medical Research- Lower Myanmar
Ethics committee address [1] 292595 0
Ethics committee country [1] 292595 0
Myanmar
Date submitted for ethics approval [1] 292595 0
Approval date [1] 292595 0
13/10/2014
Ethics approval number [1] 292595 0
54/Ethics 2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 375 375 0 0
/AnzctrAttachments/368273-ITC amended_approval_13.10.2014.pdf

Contacts
Principal investigator
Name 56150 0
Dr Jeffrey Hii
Address 56150 0
Malaria Consortium Regional Office for Asia
Room No. 805, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajavidhi Road, Bangkok 10400, Thailand
Country 56150 0
Thailand
Phone 56150 0
+66 2 354-5628
Fax 56150 0
+66 2 354-5629
Email 56150 0
j.hii@malariaconsortium.org
Contact person for public queries
Name 56151 0
Jeffrey Hii
Address 56151 0
Malaria Consortium Regional Office for Asia
Room No. 805, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajavidhi Road, Bangkok 10400, Thailand
Country 56151 0
Thailand
Phone 56151 0
+66 2 354-5628
Fax 56151 0
+66 2 354-5629
Email 56151 0
j.hii@malariaconsortium.org
Contact person for scientific queries
Name 56152 0
Jeffrey Hii
Address 56152 0
Malaria Consortium Regional Office for Asia
Room No. 805, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajavidhi Road, Bangkok 10400, Thailand
Country 56152 0
Thailand
Phone 56152 0
+66 2 354-5628
Fax 56152 0
+66 2 354-5629
Email 56152 0
j.hii@malariaconsortium.org

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
SourceTitleYear of PublicationDOI
EmbaseAcceptability of insecticide-treated clothing for malaria prevention among migrant rubber tappers in Myanmar: a cluster-randomized non-inferiority crossover trial.2017https://dx.doi.org/10.1186/s12936-017-1737-8
N.B. These documents automatically identified may not have been verified by the study sponsor.