Effectiveness of mosquito repellent for the prevention of malaria in Myanmar

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001434482
• Date of registration: 14/10/2016
• Prospective Registration: No
• Primary sponsor: Burnet Institute
• Public title: Effectiveness of mosquito repellent for the prevention of malaria in Myanmar
• Scientific title: Effectiveness of mosquito repellent delivered through village health volunteers on malaria incidence in artemisinin resistance containment programs in South-East Myanmar
• Date of first enrolment: 01/04/2015
• Target sample size: 34800
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001434482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Myanmar

Contacts

• Name: A/Prof Freya Fowkes

• Name: Dr Win Han Oo

Key inclusion & exclusion criteria

Inclusion criteria: Study sites: Villages included in the 3 Millenium Development Goal Village Health Volunteer project will be considered for inclusion in this study.

Participants: Men and women of all ages (including children) who are willing to undergo RDT test for malaria will be included. High risk populations (mobile and migrant people and residents who are also forest dwellers) will be identified by questionnaries, mapped and targeted to receive the repellent.
Exclusion criteria: Study sites: Villages included in the 3 Millenium Development Goal Village Health Volunteer project which had already received repellent.

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

Health Condition(s) or Problem(s) studied

Malaria;Drug Resistance;
Malaria
Drug Resistance

Public Health - Epidemiology

Infection - Other infectious diseases

Intervention(s)

The type of insect repellent to be distributed is N, N-diethyl-benzamide – 12% w/w, cream, 100g tube. Malaria Officers and Village Health Volunteers (VHV) will deliver repellent to migrant and mobile workers and forest dwellers by visiting dwellings where they are staying. At the time of delivery, the proper use of repellent will be explained in ethnic language (including: what is repellent and how it works; how to use/apply it (frequency, body area to apply, body parts not to apply etc); any danger/side effect and procedure for any unwanted event; contraindications; how to store it and replenish it). Participants will receive 2 tubes of repellent. When the first tube is finished recipients of the repellent will go to their VHV and exchange the depleted tube with a new tube to continue the usage of repellent.). Recipients of the repellent will be told to inform their VHV before they run out of repellent and it will be replenished to continue the usage of repellent. Given the study design, blocks of villages are stepped into the intervention at monthly intervals such that a village may be exposed to repellent distribution for a minimum of one-month or a maximum of 14-months. Chief Investigators will undertake additional sensitivity analyses exploring the extent to which the intervention was effectively distributed to and applied by village residents. Data pertaining to repellent distribution, application and knowledge of both VHVs and village residents will be sampled through surveys and will be used to conduct these additional analyses.

Primary Outcome(s)

Incidence of Plasmodium spp. infection (diagnosed by an RDT (SD bioline p.f / p.v combo test)) [15 months measurment duration including one-month where all villages are in a control state (i.e. a common baseline period). The outcome is measured at monthly intervals. i.e. 15 measurements (14 measurements where at least one block of villages are in an intervention state). ]

Secondary Outcome(s)

Incidence of symptomatic malaria (Self-reported fever/history of fever and positive RDT (SD bioline p.f / p.v combo test)[15 months measurment duration including one-month where all villages are in a control state (i.e. a common baseline period). The outcome is measured at monthly intervals. i.e. 15 measurements (14 measurements where at least one block of villages are in an intervention state). ]

Prevalence of molecular markers of artemisinin resistance (The kelch13 propeller domain of P. falciparum will be sequenced to identify mutations in this domain associated with artemisinin resistance. )[15 months measurment duration including one-month where all villages are in a control state (i.e. a common baseline period). The outcome is measured at monthly intervals. i.e. 15 measurements (14 measurements where at least one block of villages are in an intervention state). ]

Antibody level to Plasmodium spp.[15 months measurment duration including one-month where all villages are in a control state (i.e. a common baseline period). The outcome is measured at monthly intervals. i.e. 15 measurements (14 measurements where at least one block of villages are in an intervention state). ]

Incidence of PCR detectable Plasmodium spp. infection[15 months measurment duration including one-month where all villages are in a control state (i.e. a common baseline period). The outcome is measured at monthly intervals. i.e. 15 measurements (14 measurements where at least one block of villages are in an intervention state). ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Burnet Institute

Secondary Sponsor(s)

Burnet Institute Myanmar

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Ethics Committee

Status: Approved
Approval date:
Contact:

Ethics Review committee on Medical Research lnvolving Human Subjects, Department of Medical Research (Lower Myanmar