Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2025-12-17 @ 1:14 AM
Study NCT ID:
NCT04695886
Status:
None
Last Update Posted:
2021-01-05 00:00:00
First Post:
2020-12-19 00:00:00
Brief Title:
Effectiveness of a Community-delivered Integrated Malaria Elimination (CIME) Model in Myanmar
Sponsor:
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Organization:
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Study Overview
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
Status:
None
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 ie 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 eg Poisson or negative-binomial link functions mixed modelling analytical approach with maximum likelihood estimation
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 ie 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 eg Poisson or negative-binomial link functions mixed modelling analytical approach with maximum likelihood estimation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None