Trial Review

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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] 290208 0
Nil
Universal Trial Number (UTN)
U1111-1187-9584
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 300374 0
Drug Resistance 300375 0
Condition category
Condition code
Public Health 300238 300238 0 0
Epidemiology
Infection 300361 300361 0 0
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] 295971 0
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] 299715 0
Incidence of Plasmodium spp. infection (diagnosed by an RDT (SD bioline p.f / p.v combo test))
Timepoint [1] 299715 0
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] 327932 0
Incidence of symptomatic malaria (Self-reported fever/history of fever and positive RDT (SD bioline p.f / p.v combo test)
Timepoint [1] 327932 0
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 [2] 327933 0
Incidence of PCR detectable Plasmodium spp. infection
Timepoint [2] 327933 0
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 [3] 327934 0
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] 327934 0
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 [4] 327935 0
Antibody level to Plasmodium spp.
Timepoint [4] 327935 0
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).

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] 8254 0
Myanmar
State/province [1] 8254 0
Bago (East), Kayin, Kayah

Funding & Sponsors
Funding source category [1] 294580 0
Other
Name [1] 294580 0
Burnet Institute
Country [1] 294580 0
Australia
Primary sponsor type
Other
Name
Burnet Institute
Address
85 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 293449 0
Other
Name [1] 293449 0
Burnet Institute Myanmar
Address [1] 293449 0
No 226, 4th Floor, 226 Wizaya PlazaU Wisara Road
Bahan Township, Yangon 11201
Country [1] 293449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296018 0
Alfred Ethics Committee
Ethics committee address [1] 296018 0
Ethics committee country [1] 296018 0
Australia
Date submitted for ethics approval [1] 296018 0
Approval date [1] 296018 0
31/03/2015
Ethics approval number [1] 296018 0
95-15
Ethics committee name [2] 296019 0
Ethics Review committee on Medical Research lnvolving Human Subjects, Department of Medical Research (Lower Myanmar
Ethics committee address [2] 296019 0
Ethics committee country [2] 296019 0
Myanmar
Date submitted for ethics approval [2] 296019 0
Approval date [2] 296019 0
25/03/2015
Ethics approval number [2] 296019 0

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

Contacts
Principal investigator
Name 69254 0
A/Prof Freya Fowkes
Address 69254 0
Burnet Institute
85 Commercial Rd
Melbourne
VIC 3004
Country 69254 0
Australia
Phone 69254 0
+61 385262310
Fax 69254 0
Email 69254 0
[email protected]
Contact person for public queries
Name 69255 0
Win Han Oo
Address 69255 0
Burnet Institute Myanmar
No 226, 4th Floor, 226 Wizaya PlazaU Wisara Road
Bahan Township, Yangon 11201
Country 69255 0
Myanmar
Phone 69255 0
+95-1-375785
Fax 69255 0
Email 69255 0
[email protected]
Contact person for scientific queries
Name 69256 0
Freya Fowkes
Address 69256 0
Burnet Institute
85 Commercial Rd
Melbourne
VIC 3004
Country 69256 0
Australia
Phone 69256 0
+61385062310
Fax 69256 0
Email 69256 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
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.2020https://dx.doi.org/10.1371/JOURNAL.PMED.1003177
EmbaseCommunity-based molecular and serological surveillance of subclinical malaria in Myanmar.2021https://dx.doi.org/10.1186/s12916-021-01993-8
N.B. These documents automatically identified may not have been verified by the study sponsor.