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Trial registered on ANZCTR

Registration number

ACTRN12616001434482

Ethics application status

Approved

Date submitted

3/10/2016

Date registered

14/10/2016

Date last updated

14/10/2016

Type of registration

Retrospectively registered

Titles & IDs

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1187-9584

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malaria

Drug Resistance

Condition category

Condition code

Public Health

Epidemiology

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Comparator / control treatment

This study is an open stepped-wedge cluster-randomised controlled trial (randomized at the VHV level). In this approach the clusters cross-over from control (no repellent) to intervention (repellent) at regular monhtly intervals. Clusters act as their own controls as they experience both the control and intervention conditions during the study period.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of Plasmodium spp. infection (diagnosed by an RDT (SD bioline p.f / p.v combo test))

Timepoint [1]

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 [1]

Incidence of symptomatic malaria (Self-reported fever/history of fever and positive RDT (SD bioline p.f / p.v combo test)

Timepoint [1]

Secondary outcome [2]

Incidence of PCR detectable Plasmodium spp. infection

Timepoint [2]

Secondary outcome [3]

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. )

Timepoint [3]

Secondary outcome [4]

Antibody level to Plasmodium spp.

Timepoint [4]

Eligibility

Key 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.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Study sites: Villages included in the 3 Millenium Development Goal Village Health Volunteer project which had already received repellent.

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)

Centralised using electronic de-indentified village data.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Programming in the Stata statistical software package version 13.1 was undertaken to electronically allocate 116 de-indentifed villages randomaly to a series blocks or steps which determined at which month villages in a block would begin receiving the intervention. Given the total number of villages, the final design for the randomisation sequence was such that there were 13 months in which blocks of 8 villages were transitioned and one month in which 12 villages were transitioned.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Cluster stepped-wedge design

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data analysis for the stepped-wedged cluster randomized study will be performed at Burnet Institute, Melbourne using STATA version. 13.1. Difference in rates of the primary outcome Plasmodium spp. incidence will be estimated across intervention and control groups using a maximum likelihood mixed modeling/multi-level analytical approach, with villages treated as random factors - adressing the dependence in repeat measurements of incidence - and study group and time treated estimated as fixed factors.. Temporal trends of Plasmodium spp. incidence will also be explored including analysis of the effectiveness of the intervention across the study period. Sandwich estimator variance estimation will be used to adjust for potential lack of independence in observations within villages over the study period. As these analyses involve pooling study data from two separate fieldwork periods (2015 and 2016), any associated cohort effects will also be explored in the data. Analyses of secondary outcomes will involve a similar methodological approach.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/04/2015

Date of last participant enrolment

Anticipated

Actual

30/04/2015

Date of last data collection

Anticipated

Actual

30/06/2016

Sample size

Target

34800

Accrual to date

Final

34800

Recruitment outside Australia

Country [1]

Myanmar

State/province [1]

Bago (East), Kayin, Kayah

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Burnet Institute

Address [1]

85 Commercial Rd
Melbourne
VIC 3004

Country [1]

Australia

Primary sponsor type

Other

Name

Burnet Institute

Address

85 Commercial Rd
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Burnet Institute Myanmar

Address [1]

No 226, 4th Floor, 226 Wizaya PlazaU Wisara Road
Bahan Township, Yangon 11201

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Ethics Committee

Ethics committee address [1]

The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/03/2015

Ethics approval number [1]

95-15

Ethics committee name [2]

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

Ethics committee address [2]

No. 5, Ziwaka Road, Dagon Township, Yangon 11191

Ethics committee country [2]

Myanmar

Date submitted for ethics approval [2]

Approval date [2]

25/03/2015

Ethics approval number [2]

Summary

Brief summary

Malaria is an infectious disease spread by mosquitoes that causes significant illness and death in tropical regions worldwide. In some areas of South-East Asia, including Myanmar, malaria drugs do not work as well as they did in the past. This is because malaria is developing resistance to the drugs. Because of drug resistance it is important to improve ways to control malaria. Individuals may be able to protect themselves from getting malaria by using personal insect repellent. Currently there is limited published evidence to support the use of mosquito repellents for malaria control in Myanmar and indeed South-East Asia. The purpose of this study is to find out whether distributing personal insect repellent to high risk populations (mobile and migrant people and forest dwellers) through Village Health Volunteers (VHV) reduces malaria.  Mobile and migrant people and forest dwellers living in selected villages in South-East Myanmar will receive personal insect repellent from VHV to apply to their skin to prevent mosquitoes biting them. For research purposes we will decide in advance the date when people in each village receive repellent and this date will be different for different villages. The length of time that people in villages have been using repellent will be compared to the number of cases of malaria in that village over time. In this way, we will be able to see whether insect repellent distributed through VHV protects people against malaria. The 116 villages that have been selected for this study represent isolated or hard-to-reach territories identified by the Myanmar National Malaria Control Program (NMCP) as lacking malaria services. Each village will have its own VHV who will be trained in providing malaria services to their village. Malaria Officers of Karuna Mission Social Solidarity (KMSS) and VHVs will be responsible for distributing repellent in villages and surrounding areas. In addition, VHVs will perform malaria testing by using rapid diagnostic tests (RDT) on people in the village and surrounding areas to see whether they have malaria. This will be done if a person goes to see their VHV because they are sick and suspect that they may have malaria or actively by the VHV as a screening approach in the village and surrounding areas. RDTs involve taking a small pin-prick of blood from person’s finger to determine if it contains malaria infection. Information about testing and cases of malaria in each village will be collected on a monthly basis. 
RDTs are good for testing whether someone is infected with malaria at the time of the test, but RDTs cannot test 1) whether someone carries drug resistant malaria, or 2) if they have been exposed to malaria at another time. Other tests based on malaria genetic and antibody analysis respectively can be used to determine this. At the same time that VHVs are performing RDTs, another two drops of blood will be collected from the person’s finger and absorbed onto a piece of filter paper.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Freya Fowkes

Address

Burnet Institute
85 Commercial Rd
Melbourne
VIC 3004

Country

Australia

Phone

+61 385262310

Fax

freya.fowkes@burnet.edu.au

Contact person for public queries

Name

Win Han Oo

Address

Burnet Institute Myanmar
No 226, 4th Floor, 226 Wizaya PlazaU Wisara Road
Bahan Township, Yangon 11201

Country

Myanmar

Phone

+95-1-375785

Fax

winhanoo@burnetmyanmar.org

Contact person for scientific queries

Name

Freya Fowkes

Address

Burnet Institute
85 Commercial Rd
Melbourne
VIC 3004

Country

Australia

Phone

+61385062310

Fax

freya.fowkes@burnet.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.	2020	https://dx.doi.org/10.1371/JOURNAL.PMED.1003177
Embase	Community-based molecular and serological surveillance of subclinical malaria in Myanmar.	2021	https://dx.doi.org/10.1186/s12916-021-01993-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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