Effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar

Not Applicable

• Conditions: Malaria
• Interventions: Other: Community-delivered Integrated Malaria Elimination (CIME) intervention model

• Registration Number: NCT04695886
• Lead Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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.

Study Timeline

• Study First Submitted: 2020-12-19
• Status Verified: 2021-01
• Study Start: 2021-01
• Study First Submitted QC: 2021-01-03
• Last Update Submitted: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CIME intervention	Community-delivered Integrated Malaria Elimination (CIME) intervention model	Community-delivered Integrated Malaria Elimination (CIME). The CIME intervention model integrates interventions for malaria, dengue, tuberculosis, childhood diarrhoea and RDT-negative fever.

Primary Outcome Measures

Name	Time	Method
Blood examination rate	Assessed weekly, longitudinally over 6-months	Change in blood examination rate as determined by the number of rapid diagnostic tests (RDTs) for malaria performed per week per village

Secondary Outcome Measures

Name	Time	Method
Plasmodium spp. infection detected by RDT	Assessed weekly, longitudinally over 6-months.	Change in the number of Plasmodium spp. infections detected by RDT per week per village
Larval source management	Assessed weekly, longitudinally over 6-months.	Change in the number of larval sources managed by the volunteer per week
TB DOTS	6-month	Number of TB patients monitored by volunteer for DOTS over the whole study period
Seroprevalence of malaria-associated antibodies	Assessed weekly, longitudinally over 6-months	Change in the seroprevalence of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Acceptability of the CIME model by stakeholders	6-month	Acceptability of the CIME model by stakeholders assessed by focus group discussions.
Plasmodium spp. infections reported with 24 hours	Assessed weekly, longitudinally over 6-months.	Change in the number and percentage of Plasmodium spp. infections reported within 24 hours of RDT per village
Tuberculosis (TB) cases	Assessed weekly, longitudinally over 6-months	Change in the number of suspected tuberculosis cases referred for diagnosis to national tuberculosis program per week
Diarrheal cases diagnosed, treated and referred	Assessed weekly, longitudinally over 6-months	Change in the number of diarrheal cases diagnosed, treated with ORS and zinc tablets and referred per week
RDT-negative fever cases	Assessed weekly, longitudinally over 6-months	Change in the number of RDT-negative fever cases referred per week
Malaria treatment according to national policy	Assessed weekly, longitudinally over 6-months	Change in the proportion of patients with confirmed malaria who received first-line antimalarial treatment according to national policy
Plasmodium spp. infection detected by PCR	Assessed weekly, longitudinally over 6-months.	Change in the number of Plasmodium spp. infections detected by polymerase chain reaction (PCR) (from RDT cassette) per week
Dengue cases	Assessed weekly, longitudinally over 6-months.	Change in the number of suspected Dengue cases referred to the nearby clinic per week
Malaria drug resistance-associated mutations	Assessed weekly, longitudinally over 6-months	Change in the proportion of Kelch13 and other resistance mutations detected by PCR from RDT cassettes
Levels of malaria-associated antibodies	Assessed weekly, longitudinally over 6-months	Change in the levels of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette
Data accuracy and completeness in reporting of malaria cases	Assessed weekly, longitudinally over 6-months	Change in the number of accurately reported and complete malaria case records according the national malaria case-based reporting format
Acceptability of the CIME model by villagers	6-month	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.
Acceptability of the CIME model by CIME volunteers	6-month	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.
Cost-effectiveness of the CIME model	6-month	Cost-effectiveness of the CIME model compared to ICMV model (Cost per unit detection, treatment and notification of a malaria case)