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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04695886
• Other study ID #: 241/20_CIME_Malaria
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: Freya Fowkes, DPhil
• Phone: +61385062310
• Email: freya.fowkes[@]burnet.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6440
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	National Malaria Control Program, Myanmar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessed weekly, longitudinally over 6-months
Secondary	Plasmodium spp. infection detected by RDT	Change in the number of Plasmodium spp. infections detected by RDT per week per village	Assessed weekly, longitudinally over 6-months.
Secondary	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	Assessed weekly, longitudinally over 6-months.
Secondary	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	Assessed weekly, longitudinally over 6-months.
Secondary	Larval source management	Change in the number of larval sources managed by the volunteer per week	Assessed weekly, longitudinally over 6-months.
Secondary	Dengue cases	Change in the number of suspected Dengue cases referred to the nearby clinic per week	Assessed weekly, longitudinally over 6-months.
Secondary	Tuberculosis (TB) cases	Change in the number of suspected tuberculosis cases referred for diagnosis to national tuberculosis program per week	Assessed weekly, longitudinally over 6-months
Secondary	TB DOTS	Number of TB patients monitored by volunteer for DOTS over the whole study period	6-month
Secondary	Diarrheal cases diagnosed, treated and referred	Change in the number of diarrheal cases diagnosed, treated with ORS and zinc tablets and referred per week	Assessed weekly, longitudinally over 6-months
Secondary	RDT-negative fever cases	Change in the number of RDT-negative fever cases referred per week	Assessed weekly, longitudinally over 6-months
Secondary	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	Assessed weekly, longitudinally over 6-months
Secondary	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	Assessed weekly, longitudinally over 6-months
Secondary	Malaria drug resistance-associated mutations	Change in the proportion of Kelch13 and other resistance mutations detected by PCR from RDT cassettes	Assessed weekly, longitudinally over 6-months
Secondary	Seroprevalence of malaria-associated antibodies	Change in the seroprevalence of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette	Assessed weekly, longitudinally over 6-months
Secondary	Levels of malaria-associated antibodies	Change in the levels of anti-malarial antibodies detected by enzyme-linked immunosorbent assay (ELISA) from RDT cassette	Assessed weekly, longitudinally over 6-months
Secondary	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.	6-month
Secondary	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.	6-month
Secondary	Acceptability of the CIME model by stakeholders	Acceptability of the CIME model by stakeholders assessed by focus group discussions.	6-month
Secondary	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)	6-month