In Myanmar, community health workers, known as malaria volunteers, have played a key role in reducing the malaria burden in the malaria control phase, providing essential malaria services in rural areas where the coverage of formal health services is limited. However, the community-delivered models that have worked well for malaria control may not work well for malaria elimination. In parallel with switching from interventions for malaria control to those for elimination, the motivation and social importance of malaria volunteers has declined along with the decline of the malaria burden. To sustain volunteer motivation, the social importance and effectiveness in the malaria elimination program, the Community-delivered Integrated Malaria Elimination model for Myanmar (CIME model) was developed based on global evidence and qualitative consultations with community members, leaders, volunteers and health stakeholders in Myanmar. This study will assess the level of effectiveness of the CIME model in increasing malaria testing by its application in an open cluster-randomised controlled stepped-wedge trial.
The CIME model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and Rapid Diagnostic Test (RDT)-negative fever. It will involve the recruitment and training of a volunteer to implement the CIME model in each village. The primary outcome of the trial is blood examination rate as determined by number of RDTs for malaria performed per week per village. 140 villages in 8 townships across Ayeyarwaddy, Bago and Yangon Regions and Kayah State in Myanmar will be sampled at random with probability proportional to size. Study populations include villages with ICMVs who will be re-trained as CIME volunteers (intervention phase) and the community members in the service catchment areas of those volunteers. An open stepped-wedge cluster-randomised controlled trial, randomized at the volunteer level (i.e. the volunteer and the village / workplaces they service), will be conducted over 6-months to evaluate the effectiveness and cost-effectiveness of the CIME model intervention. The stepped-wedge design will comprises 24 weekly measurements of the number of malaria blood examinations performed by each village, with villages grouped into 10 blocks of 14 villages and transitioned from control to intervention phases at bi-weekly intervals following a universal two-week control period. Differences in the per weekly rate of blood examination (primary outcome), will be estimated across intervention and control phases using a generalised linear (e.g. Poisson or negative-binomial link functions) mixed modelling analytical approach with maximum likelihood estimation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
6,440
Malaria: Malaria Diagnosis using RDT, treatment, referral and reporting; Prevention interventions (Behavioral Change Communication, net and repellent distribution); assisting in case and foci investigation and larval source management. Dengue: Assisting in dengue prevention; Referral of cases. Tuberculosis (TB): Detection and referral of suspected cases; Contact tracing; Directly observed treatment, short-course (DOTS) providers; defaulter tracing; follow-up sputum examinations; assisting in TB health education talks and active case detection activities. Childhood diarrhea: Prevention; Health education and Water, sanitation and hygiene (WASH) promotion; Diagnosis and dehydration assessment; Treatment and referral; Rehydration therapy using Oral Rehydration Solution (ORS) and oral Zinc tablet; assisted referral. RDT-negative fever: Prevention and health education; Symptomatic treatment with antipyretics and immediate assisted referral.
Blood examination rate
Change in blood examination rate as determined by the number of rapid diagnostic tests (RDTs) for malaria performed per week per village
Time frame: Assessed weekly, longitudinally over 6-months
Plasmodium spp. infection detected by RDT
Change in the number of Plasmodium spp. infections detected by RDT per week per village
Time frame: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infections reported with 24 hours
Change in the number and percentage of Plasmodium spp. infections reported within 24 hours of RDT per village
Time frame: Assessed weekly, longitudinally over 6-months.
Plasmodium spp. infection detected by PCR
Change in the number of Plasmodium spp. infections detected by polymerase chain reaction (PCR) (from RDT cassette) per week
Time frame: Assessed weekly, longitudinally over 6-months.
Larval source management
Change in the number of larval sources managed by the volunteer per week
Time frame: Assessed weekly, longitudinally over 6-months.
Dengue cases
Change in the number of suspected Dengue cases referred to the nearby clinic per week
Time frame: Assessed weekly, longitudinally over 6-months.
Tuberculosis (TB) cases
Change in the number of suspected tuberculosis cases referred for diagnosis to national tuberculosis program per week
Time frame: Assessed weekly, longitudinally over 6-months
TB DOTS
Number of TB patients monitored by volunteer for DOTS over the whole study period
Time frame: 6-month
Diarrheal cases diagnosed, treated and referred
Change in the number of diarrheal cases diagnosed, treated with ORS and zinc tablets and referred per week
Time frame: Assessed weekly, longitudinally over 6-months
RDT-negative fever cases
Change in the number of RDT-negative fever cases referred per week
Time frame: Assessed weekly, longitudinally over 6-months
Malaria treatment according to national policy
Change in the proportion of patients with confirmed malaria who received first-line antimalarial treatment according to national policy
Time frame: Assessed weekly, longitudinally over 6-months
Data accuracy and completeness in reporting of malaria cases
Change in the number of accurately reported and complete malaria case records according the national malaria case-based reporting format
Time frame: Assessed weekly, longitudinally over 6-months
Malaria drug resistance-associated mutations
Change in the proportion of Kelch13 and other resistance mutations detected by PCR from RDT cassettes
Time frame: Assessed weekly, longitudinally over 6-months
Seroprevalence of malaria-associated antibodies
Change in the seroprevalence of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Time frame: Assessed weekly, longitudinally over 6-months
Levels of malaria-associated antibodies
Change in the levels of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Time frame: Assessed weekly, longitudinally over 6-months
Acceptability of the CIME model by villagers
Acceptability of the CIME model by villagers assessed by an investigator-developed questionnaire including component constructs such as affective attitude, burden, perceived effectiveness and self-efficacy.
Time frame: 6-month
Acceptability of the CIME model by CIME volunteers
Acceptability of the CIME model by CIME volunteers assessed by an investigator-developed questionnaire including component constructs such as affective attitude, burden, perceived effectiveness and self-efficacy.
Time frame: 6-month
Acceptability of the CIME model by stakeholders
Acceptability of the CIME model by stakeholders assessed by focus group discussions.
Time frame: 6-month
Cost-effectiveness of the CIME model
Cost-effectiveness of the CIME model compared to ICMV model (Cost per unit detection, treatment and notification of a malaria case)
Time frame: 6-month
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