Preference and acceptability of insecticide-treated clothing (ITC) for malaria prevention among rubber tappers in Myanmar

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000432516
• Date of registration: 06/05/2015
• Prospective Registration: No
• Primary sponsor: Department for International Development (DFID)
• 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
• Date of first enrolment: 10/02/2015
• Target sample size: 240
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000432516.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;
• Phase: Not Applicable

Countries of recruitment

Myanmar

Contacts

• Name: Dr Jeffrey Hii

• Name: Dr Jeffrey Hii

Key inclusion & exclusion criteria

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).

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.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Other public health

Infection - Other infectious diseases

Malaria prevention;
Malaria prevention

Intervention(s)

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

Primary Outcome(s)

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). [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(s)

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)
[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 ID(s)

Nil

Source(s) of Monetary Support

Department for International Development (DFID)

President's Malaria Initiative (PMI)

Secondary Sponsor(s)

President's Malaria Initiative (PMI)

Ethics review

Status: Approved
Approval date:
Contact:

Institutional Ethics Review Committee, Department of Medical Research- Lower Myanmar