Clinical trial NCT04695886: Effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar
Official title: Evaluation of the Effectiveness and Cost-effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar: An Open Stepped-wedge Cluster-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Keywords: Community-delivered
Intervention
elimination
falciparum
vivax
routine testing
Stepped-wedge
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: National Malaria Control Program, Myanmar
First posted: 2021-01-05
Enrollment: 6440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized control trial (one-way crossover)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Villages in Ayeyarwaddy, Bago and Yangon Regions and Kayah State townships in Myanmar with National Malaria Control Program (NMCP) trained Integrated Community Malaria Volunteers (ICMVs).

Exclusion Criteria:

* Townships

A township will be excluded from the study if:

1. The township does not have an NMCP provided ICMV network
2. The township has ongoing armed conflict
3. The township does not have Vector-Borne Diseases Control (VBDC) staff or malaria focal person
4. The location of the township is not geographically or politically feasible for staff from the State/Regional capital city to conduct regular supervision visits

Villages

After selection of 8 townships (2 townships from each state/region), villages in the townships will be screened against the exclusion criteria. A village will be excluded from the study if:

1. The village is too remote and unable to execute the CIME model completely,
2. The village has a government public health facility,
3. The village has no mobile network coverage
4. The village is in the ongoing armed conflict zone , or
5. The village has an ICMV program operated by any organizations other than NMCP
6. The village has an Annual Parasite Index (API) \>=5

Primary outcomes:
measure: Blood examination rate
timeFrame: Assessed weekly, longitudinally over 6-months
Secondary outcomes:
measure: Plasmodium spp. infection detected by RDT
timeFrame: Assessed weekly, longitudinally over 6-months.
measure: Plasmodium spp. infections reported with 24 hours
timeFrame: Assessed weekly, longitudinally over 6-months.
measure: Plasmodium spp. infection detected by PCR
timeFrame: Assessed weekly, longitudinally over 6-months.
measure: Larval source management
timeFrame: Assessed weekly, longitudinally over 6-months.
measure: Dengue cases
timeFrame: Assessed weekly, longitudinally over 6-months.
measure: Tuberculosis (TB) cases
timeFrame: Assessed weekly, longitudinally over 6-months
measure: TB DOTS
timeFrame: 6-month
measure: Diarrheal cases diagnosed, treated and referred
timeFrame: Assessed weekly, longitudinally over 6-months
measure: RDT-negative fever cases
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Malaria treatment according to national policy
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Data accuracy and completeness in reporting of malaria cases
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Malaria drug resistance-associated mutations
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Seroprevalence of malaria-associated antibodies
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Levels of malaria-associated antibodies
timeFrame: Assessed weekly, longitudinally over 6-months
measure: Acceptability of the CIME model by villagers
timeFrame: 6-month
measure: Acceptability of the CIME model by CIME volunteers
timeFrame: 6-month
measure: Acceptability of the CIME model by stakeholders
timeFrame: 6-month
measure: Cost-effectiveness of the CIME model
timeFrame: 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Burnet Institute
name: Freya Fowkes, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Burnet Institute
name: Win Han Oo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oo WH, Thi A, Htike W, Agius PA, Cutts JC, Win KM, Yi Linn NY, Than WP, Hkawng GN, Thu KM, Oo MC, O'Flaherty K, Kearney E, Scott N, Phyu PP, Htet AT, Myint O, Lwin Yee L, Thant ZP, Mon A, Htike S, Hnin TP, Fowkes FJI. Evaluation of the effectiveness and cost effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) model in Myanmar: protocol for an open stepped-wedge cluster-randomised controlled trial. BMJ Open. 2021 Aug 13;11(8):e050400. doi: 10.1136/bmjopen-2021-050400.