Study Title

Alternative Study/Cohort Name(s)

Key Institution involved

Partner Institution(s) involved

Key Contact for the Study

Brief Study Explanation

Year(s) of Study

Time Frame of Study (months)

Number of Measurements and Time Between Measurements

Study Type (CSS, Cohort, etc)

Location of Study (Country)

Location of Study (Sites)

Geospatial Coordinates

Study Population

Size of Study Cohort/Sample set to be reqcruited

Actual size of Study Cohort/Sample set to be reqcruited

Age of Participants

Exposure/Intervention Variable(s)

Outcome Variable

Sample Collection Methods

Types of Sample

Sample ID

Current Sample Location(s)

Aliquot Distribution

Plasmodium Species Studied

Infection Status by LM

Infection Status by RDT

Infection Status by PCR

Infection Status by Serology

Blood Stage Data Availability

Species Specific Data

Gametocyte Data Availability

Denisty Data Availability

Clinical Incidence

Drug Regimen (For treatment studies)

Availability of Data on Related Conditions

Availability of Demographic Data

Availability of Entomology Data and Data Type

Ethical Approval (and consent of participants)

Australian Ethics Number

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Publications/
Links

A stepped-wedge cluster randomised trial of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar

Burnet Institute, Victoria, Australia, and Yangon, Myanmar.

Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar

Freya Fowkes

The aim of the trial was to assess the effectiveness of personal insect repellent distributed to villages through Village Health Volunteers (VHVs) in malaria control and elimination programs for artemisinin resistance containment in geographically isolated, high-risk populations in Myanmar. Furthermore, the trial aimed to understand the broader implications of personalised malaria control measures, specifically on the presence of molecular-detected P. falciparum and P. vivax parasites, parasite mutations that confer drug resistance and its impact on naturally-acquired immunity to malaria. Additionally, studies were conducted to integrate a more sensitive diagnostic molecular and serological measures into the VHV network that could improve surveillance of residual malaria transmission in hard-to-reach areas in the region.

2015 and 2016

April 2015 to June 2016

20 participants per village were samples monthly, in a total of 14 months

open stepped-wedge cluster-randomised controlled trial, randomised at the village level
o RCT, trial registration number: retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN126 16001434482) on 14 October 2016.

Myanmar

Isolated villages (114) and hard-to-reach territories in the states of Kayin, Kayah, Bago East region

Available for majority of villages

For high risk populations (mobile and migrant people and residents who are also forest dwellers) over 6 months of age received the repellent.

Individuals of all ages and genders willing to undergo RDT for malaria from villages included in the 3MDG (Three Millennium Development Goal) malaria program, who had not previously received repellent.

20 participants/village, being all ages for RDT, and >6 months for repellent study.

32,194 RDTs/total observations and 14,128 dried blood spots from 10,857 individuals.

0.1 to 100 years old

Topical insect repellent (12% N,N-diethylbenzamide w/w cream)

prevalence of P. falciparum and P. vivax infection, levels and seroprevalence of IgG for both species, contemporaneous infection, infection at next presentation, cost-effectiveness of repellent, adherence to intervention (repellent)

dry blood spot (DBS)

dry blood spot (DBS), DNA

Burnet Institute

14,128 dried blood spots, Burnet Institute, contact Katherine O’Flaherty or Freya Fowkes

Plasmodium falciparum, Plasmodium vivax

N/AAvailable

qPCR – available

IgG analysis – available

qPCR, serology

Pf, pv

N/A

N/A

Fever and RDT positive recorded

N/A

N/A

pregnancy, RDT result, uncomplicated/severe malaria, reported malaria symptoms

N/A

The trial was explained to the community, and community leaders and stakeholders gave community consent for the distribution of insect repellent, so the individuals were not required to sign a consent form in order to receive repellent. An informed consent form written in ethnic language was provided to men, women, and parents of children given a RDT for malaria. Informed consent was sought from individuals who provided to a finger prick sample of blood onto filter paper. Unrestricted informed consent will be requested for use of leftover filter paper samples in future studies. Any new tests not covered in the present protocol will not be carried out unless a separate approval is obtained from the relevant ethics committees in Myanmar and Melbourne

Alfred Hospital, Melbourne, Australia (95/15)

Ethics Review Committee on Medical Research involving Human Subjects, Department of Medical Research, Ministry of Health and Sports, Myanmar Government (#21/Ethics/2015; extended approval #Ethics/DMR/2016/020). The ethics review committee of the Department of Medical Research, Ministry of Health and Sports, requested that there be no commercial advantage for the product during the trial. Consequently, the repellent was provided in plain unbranded tubes, and the investigators registered the trial after completion of fieldwork (but prior to the commencement of data analysis) to minimise public disclosure.

https://doi.org/10.1371/journal.pmed.1003177

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine Research, University of Oxford, Oxford OX3 7FZ, United Kingdom

Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC 3010, Australia; 

Worldwide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford OX3 7FZ, United Kingdom

Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852

National Center for Parasitology, Entomology and Malaria Control, Phnom Penh 12101, Cambodia

Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand

Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Quan 5, Ho Chi Minh City, Vietnam

Department of Medical Research, Lower Myanmar, Yangon 11191, Myanmar

Lao-Oxford-Mahosot Hospital-Wellcome Trust-Research Unit, Mahosot Hospital, Vientiane, Lao PDR

Malaria Research Group & Dev Care Foundation, Chittagong, Bangladesh

Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Tak 63110, Thailand

Kinshasa School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo

Department of Paediatrics and Child Health, University of Ilorin, Ilorin, Nigeria

Blood smears taken for malaria parasite counts at 0, 4, 6, 8, 12 hours and then every 6 hours until two consecutive counts were negative, days 7, 14, 28 and 42.

RCT (therapeutic efficacy trial)
o If RCT, trial registration number: ClinicalTrials.gov number, NCT01350856

parasite clearance half-life (hours), parasite clearance half-life of more than 5 hours, parasitemia detected on day 3, gametocytemia after treatment, the incidence of anaemia, efficacy of the 6-day artesunate regimen plus artemisinin-based combination therapy, corrected by means of PCR genotyping, treatment, duration of treatment, duration of follow-up, total number of patients, number of patients with recurrence of infection, efficacy (with and without PCR correction), adverse events, parasitemia (blood and sexual stage) by LM at follow-up timepoints.

Plasma

KH***-***; NG***-***, TH***-***, MM***-***, BD***-***, VN***-***, LA***-***, NG***-***, CD***-***

Burnet Institute, MORU/WWARN

Aliquots for all participant samples (n = 1,114) located at Burnet Institute but sample volume is extremely limited, contact Freya Fowkes or Katherine O’Flaherty

PCR genotyping of LM positives

Available

LM (PCR genotyping), serology.

Pf

yes, blood and sexual stage, LM only

Uncomplicated Pf malaria (fever and LM) inclusion criteria

Participants were randomised to receive either 2 or 4 mg/kg artesunate for 3 days followed by a full course of an ACT at most sites. In Western Cambodia and Srisaket, Thailand, where higher grade artemisinin resistance was already reported, only the 4 mg/kg dose was evaluated.

N/A