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Trial registered on ANZCTR


Registration number
ACTRN12610000706077
Ethics application status
Approved
Date submitted
23/08/2010
Date registered
25/08/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community volunteers as agents for improving early diagnosis and appropriate treatment of malaria in Bago Division, Myanmar
Scientific title
Cluster randomized trial on the use of community volunteers to improve early diagnosis and appropriate treatment of malaria in Bago Division, Myanmar
Secondary ID [1] 252550 0
'None'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early diagnosis and treatment of malaria 258030 0
Trained volunteers can reduce malaria mortality? 258031 0
Acceptability of trained volunteers for malaria diagnosis and treatment by the health staff 258032 0
Acceptability of trained volunteers for malaria diagnosis and treatment by community 258033 0
Condition category
Condition code
Public Health 258197 258197 0 0
Health service research
Infection 258198 258198 0 0
Other infectious diseases
Public Health 258199 258199 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Based on the malaria endemicity as identified by Vector Borne Disease Control (VBDC) Programme and Japan International Cooperation Agency (JICA), Bago Division, villages in the highest malaria endemic areas (“Stratum 1a”) will be selected. Inaccessible villages and villages with less than 70 households will be excluded. High travel cost may also be the reason for exclusion.
Selected villages before randomization will include Baw Nat Kyi, Chin Su, Nat Set, Wa Paing, Wun Kite Sho in Bago township, Baya Ngot To, Chin Su-Daik U, Gway Pin Kuu, Myo Yoe, Pyin Taung Twin, Shwe Nyaung Pin, Taung Thar, Tha Htay Gone villages in Daik U township, Chaung Saut, Moe Ma Kha, Myo Chaung, Nyaung Pin Tha, Pay Kone, Tha Htay Gyi and Than Pa Yar Khone in Kyauk Taga township, Gyo Gone, Koe Gwa, Kyet Tet Nyaung Pin, Sa Pa Kyi, Shwe Laung, Thar Yar Gone, Thaung Tan villages in Oak Twin township, Htone Bo, Kaya Pyone Chaung, Kyauk Pa Toe, Ma U Taw Gyu Zaung, Ta Pyae and Ye Owe Sin villages in Taungoo township, Dauk Inn Gone, Khin Tann, Na Jat, Pa Dauk Kone, Thae Kaw, Thaung Kyi and Thit Cha Seit villages in Ye Dar Shay township. Of these, 20 villages will be randomly selected to select and train a community volunteer each.

We will conduct training of community volunteers on the use of malaria rapid diagnostic test (Paracheck Pf) for diagnosis of malaria and treatment with artemisinin based combination therapy (ACT) in remote villages where there is no health staff employed.

Malaria rapid diagnostic test (RDT) is available as an easy tool for diagnosis of malaria for lay people after receiving job aid plus training for a short duration(Harvey, 2008). It detects specific antigen (protein) produced by malaria parasite in the blood of infected or recently infected people. The recommended sensitivity is 95% or more at 100 or more parasites/microlitre for P.falciparum (World Health Organization Regional Office for the Western Pacific, 2004). Training for use of RDT indicates that RDTs are comparable to field microscopes in rural settings, cost-effective and needs a job aid plus training for 3 hours duration with the available WHO training materials on proper RDT use (The Quality Assurance Project and the World Health Organization, 2006). Paracheck Pf manufactured by Orchid Biomedical Systems, Goa, India (registered trademark) is appropriate for malaria areas with P.falciparum infection and it detects only Plasmodium falciparum by histidine-rich protein-2 (HRP2).
Coartem (artemether 20 mg/lumefantrine 120 mg) is an artemisinin-based combination therapy (ACT) indicated for the treatment of acute uncomplicated plasmodium falciparum malaria, the most dangerous form of the disease. Coartem is produced by the Swiss pharmaceutical company, Novartis. Coartem is a highly effective and well-tolerated malaria treatment, providing cure rates of up to 97%, even in areas of multi-drug resistance. Coartem is approved in over 80 countries worldwide, including various countries in Africa, as well as by stringent regulatory authorities including Swissmedic, the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA). The number of tablets of Coartem in strips presentation differs by age group and body weight in kilogram. On the strip, a simple instruction is written for tablets to be taken orally twice a day for three days. Chloroquine is a recommended treatment for non-falciparum malaria in Myanmar. The dose for adult is 4 tablets on the first day, 4 tablets on the second day and 2 on the third day.

Volunteers’ training will be conducted in Bago Divisional Health Office. Volunteers from 6 townships (Bago, Daik U, Kyauk Taga, OaK Twin, Taungoo and Ye Dar Shay) will be trained for two days with practical demonstration and exercise by local malaria supervisors and laboratory technician of Bago Vector Borne Disease Control team in Bago. The currently available training module for volunteers in Myanmar will be revised on the basis of WHO training materials on RDT use and job aid illustration(The Quality Assurance Project and the World Health Organization, 2006) that have been tested in a previous study(Harvey, 2008). The training module will consist of the topics on what is malaria, how to do RDT, treatment regimen for RDT positive patients and RDT negative patients, symptoms suggesting for referral of patients to the nearest health service provider, record keeping and reporting. Possible misdiagnosis (particularly pneumonia in children) will also be emphasized. The danger signs will be provided for referral of adults and children. Since previous study showed that the volunteers referred only few children with danger signs(Chinbuah, 2006), it will be recommended to refer all sick children under 5 years immediately after initial RDT and provision of antimalarials. The illustrations will be made on test procedure of RDT. Based on current antimalarial treatment guideline of the National Malaria Control Programme, treatment chart on dose and duration of treatment for different age groups on the basis of RDT result will be given to volunteers.
Practical exercise will be performed during training on conduct of RDT. Each volunteer will be trained to do at least two RDT tests during the training sessions. At the end of two days training, the assessment will be made using the checklist (Harvey, 2008) to ensure their capability for malaria diagnosis and treatment.
The water proof material will be used for treatment chart and will be displayed in the house of community volunteer. The village people will be informed through local village leader on availability of volunteer for malaria diagnosis. A notice board indicating the malaria clinic at the volunteer’s house will be used in the village as arranged by the local village leader. With the approval from the VBCD programme, a certificate on being community volunteer for the intervention period will be issued to the volunteer to be displayed in the clinic.
The diagnostic and treatment materials such as RDT, cotton, spirit, disposable gloves, lancet and medicine (Coartem, chloroquine and paracetamol), log book register for record keeping will be given to community volunteers as provided by the programme throughout the study period (at least one year and probably assessment of mortality at two years after training volunteers).
Follow-up supervision will be made weekly for the first month and fortnightly for the subsequent months for volunteers. The local malaria supervisor will arrange for follow-up of community volunteers for supervision including their RDT performance, treatment provision and collection of patient’s record card. The overall duration of this study will be one year. However, the mortality information may be collected up to two years after intervention commencement.
Intervention code [1] 257072 0
Diagnosis / Prognosis
Intervention code [2] 257073 0
Early detection / Screening
Intervention code [3] 257074 0
Treatment: Drugs
Comparator / control treatment
Out of selected villages, after randomization of villages, 20 will be control villages and villagers will only receive malaria diagnosis and artemisinin based combination therapy from midwives in nearby villages or in hospital as available in the routine health system.
Control group
Active

Outcomes
Primary outcome [1] 259055 0
Interval between the first febrile episode and diagnosis by rapid diagnostic test
Timepoint [1] 259055 0
at baseline and at 6 months after intervention
Primary outcome [2] 259056 0
Proportions of population with fever who receive malaria diagnosis and appropriate treatment
Timepoint [2] 259056 0
at baseline and at 6 months after intervention commencement
Primary outcome [3] 259057 0
Mortality from all causes
Timepoint [3] 259057 0
at 6 and 12-18 months after intervention commencement
Secondary outcome [1] 265320 0
Mortality from malaria
Timepoint [1] 265320 0
at 12 months and 24 months after intervention commencement
Secondary outcome [2] 265321 0
Period prevalence of malaria
Timepoint [2] 265321 0
at 6 months after intervention commencement
Secondary outcome [3] 265326 0
Acceptability of volunteer system by health staff and community

Acceptability of volunteer system by the health staff will be assessed by self-administered questionnaire on pay day in all selected six townships in the baseline and at 6 months after intervention. The questionnaire will include a brief instruction to fill in one to two pages form anonymously. It will include both structured and open ended questions. A secret ballot will be used to let health staff put the forms into it. Moreover, qualitative in-depth interviews with malaria supervisors and informal conversation with health staff will also be noted during data collection period.
Regarding the acceptability of volunteers by the community, the structured interview questionnaire for subjects with fever within the last 30 days will include questions on their acceptability as well as seeking treatment from the volunteer. In-depth interviews will be made for 10 subjects who did not seek treatment from volunteers to identify the reasons. Focus group discussions with village leaders will be performed in villages with trained community volunteers to explore the acceptability of volunteer system.
Timepoint [3] 265326 0
at baseline and at 6 months after intervention commencement

Eligibility
Key inclusion criteria
Subject older than 6 months with history of fever within one month, but not within 24 hours at the time of data collection in a malaria endemic village
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fever within 24 hours

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
40 malaria endemic villages where there is no health staff will be randomized into 20 intervention villages and 20 control villages. A community volunteer each from intervention villages will be trained on the use of rapid diagnostic test (RDT) for malaria diagnosis and treatment with artemisinin based combination therapy (ACT). A subject with fever in the intervention village can seek treatment from volunteer as well as from the midwife in nearby village employed in the routine health system. A subject with fever in control village can seek treatment from midwife in nearby village available in the routine health system. There is no allocation concealment procedure.
Verbal autopsy with international standard guidline questionnaire will be done for deceased persons.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Firstly, a list of subjects with fever within 30 days will be prepared during house to house survey. Then, eligible subjects with history of fever will be selected for interview. If the number of subjects with history of fever within 30 days that can be traced for house to house data collection is more than 20 in a village, only 20 will be selected by simple randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
640
Accrual to date
Final
Recruitment outside Australia
Country [1] 2830 0
Myanmar
State/province [1] 2830 0
Bago

Funding & Sponsors
Funding source category [1] 257515 0
Charities/Societies/Foundations
Name [1] 257515 0
World Health Organization Regional Office for the South-East Asia - UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) Small Grants Programme (WHO/SEARO-TDR Small Grants Programme)
Country [1] 257515 0
India
Primary sponsor type
Charities/Societies/Foundations
Name
World Health Organization Regional Office for the South-East Asia - UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) Small Grants Programme (WHO/SEARO-TDR Small Grants Programme)
Address
World Health Organization,
Regional Office for South-East Asia,
World Health House,
Indraprastha Estate,
Mahatma Gandhi Marg,
New Delhi 110 002,
India
Country
India
Secondary sponsor category [1] 256749 0
Government body
Name [1] 256749 0
Department of Medical Research (Lower Myanmar), Ministry of Health, Myanmar
Address [1] 256749 0
No.5, Ziwaka Road, Dagon PO, Yangon, Myanmar
Country [1] 256749 0
Myanmar
Other collaborator category [1] 251451 0
Government body
Name [1] 251451 0
National malaria control programme, Department of Health, Ministry of Health, Myanmar
Address [1] 251451 0
Vector Borne Disease Control Programme, Department of Health, Nay Pyi Taw, Ministry of Health, Myanmar
(area code - 067)
Country [1] 251451 0
Myanmar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259542 0
Ethical Review Committee on Medical Research Involving Human Subjects, Department of Medical Research (Lower Myanmar)
Ethics committee address [1] 259542 0
Ethics committee country [1] 259542 0
Myanmar
Date submitted for ethics approval [1] 259542 0
Approval date [1] 259542 0
26/05/2007
Ethics approval number [1] 259542 0
4/Ethics/2007
Ethics committee name [2] 259545 0
The Ethics Committee, Faculty of Medicine, Prince of Songkla University
Ethics committee address [2] 259545 0
Ethics committee country [2] 259545 0
Thailand
Date submitted for ethics approval [2] 259545 0
Approval date [2] 259545 0
03/12/2008
Ethics approval number [2] 259545 0
EC 52-054-18-6-2

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

Contacts
Principal investigator
Name 31560 0
Address 31560 0
Country 31560 0
Phone 31560 0
Fax 31560 0
Email 31560 0
Contact person for public queries
Name 14807 0
Dr Ohnmar
Address 14807 0
Research Scientist
Epidemiology Research Division
Department of Medical Research (Lower Myanmar)
No.5, Ziwaka Road, Dagon PO,
Yangon, Myanmar
Country 14807 0
Myanmar
Phone 14807 0
+95 1 375457 ext 127 (for Office in Yangon, Myanmar)
Fax 14807 0
+95 1 251514 (Office in Yangon, Myanmar)
Email 14807 0
[email protected]
Contact person for scientific queries
Name 5735 0
Dr Ohnmar
Address 5735 0
Research Scientist
Epidemiology Research Division
Department of Medical Research (Lower Myanmar)
No.5, Ziwaka Road, Dagon PO,
Yangon, Myanmar
Country 5735 0
Myanmar
Phone 5735 0
+95 1 375457 ext 127 (for Office in Yangon, Myanmar) +66 74 429754 (Epidemiology Unit, Prince of Songkla University, Hat Yai, Thailand)
Fax 5735 0
+95 1 251514 (Office in Yangon, Myanmar)
Email 5735 0
[email protected]

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