RecruitingPhase 4ACTRN12610000706077

Community volunteers as agents for improving early diagnosis and appropriate treatment of malaria in Bago Division, Myanmar

Cluster randomized trial on the use of community volunteers to improve early diagnosis and appropriate treatment of malaria in Bago Division, Myanmar


Sponsor

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)

Enrollment

640 participants

Start Date

May 21, 2009

Study Type

Interventional

Conditions

Summary

This study will be carried out to determine the effect of the use of trained community volunteers on early diagnosis and prompt treatment of malaria and its impact on malaria morbidity and mortality in malaria endemic areas of Bago Division, Myanmar. It will be a community based intervention study using randomized clusters controlled design. After the baseline assessment on utilization of health staff by malaria patients in both areas, the community health volunteers will be selected and trained in intervention area. Post-intervention assessment will be done after 6 months. Quantitative information will be collected through household based survey using pre-tested structured questionnaires for those with malaria fever within the last month. A log book register will be used by health staff and community health volunteers to make record on particulars of the patients who consulted for malaria fever and treatment service provided. A calendar card will also be used by each service provider on availability in the village under study. Qualitative information will be collected from health staff, community health volunteers and community members in baseline as well as post-intervention assessments. Verbal autopsy will be done to identify the cause of deaths in study areas for comparison between intervention and control villages. The results will be useful for National Malaria Control Programme in improving early diagnosis and treatment for malaria in remote areas.


Eligibility

Sex: Both males and femalesMin Age: 6 Monthss

Inclusion Criteria1

  • 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

Exclusion Criteria1

  • Fever within 24 hours

Interventions

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

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.


Locations(1)

Bago, Myanmar

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000706077