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

NCT04695886 | Unknown

• 1 other identifier: 241/20_CIME_Malaria
• Study Type: interventional
• Target: 6,440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria

Keywords

Community-delivered; Intervention; elimination; falciparum; vivax; routine testing; Stepped-wedge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Plasmodium spp. infection detected by RDT

  Assessed weekly, longitudinally over 6-months.

• Plasmodium spp. infections reported with 24 hours

  Assessed weekly, longitudinally over 6-months.

• Plasmodium spp. infection detected by PCR

  Assessed weekly, longitudinally over 6-months.

• Larval source management

  Assessed weekly, longitudinally over 6-months.

• Dengue cases

  Assessed weekly, longitudinally over 6-months.

Study Arms (2)

CIME intervention

EXPERIMENTAL

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

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

ICMV standard of care

NO INTERVENTION

Integrated Community Malaria Volunteer (ICMV) model - this is the current standard of care. This model involves malaria volunteers undertaking additional screening and referral services for a range of other diseases including: dengue, lymphatic filariasis, tuberculosis, HIV/AIDS and leprosy.

Interventions

Community-delivered Integrated Malaria Elimination (CIME) intervention model OTHER

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.

CIME intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Townships
• A township will be excluded from the study if:
• The township does not have an NMCP provided ICMV network
• The township has ongoing armed conflict
• The township does not have Vector-Borne Diseases Control (VBDC) staff or malaria focal person
• 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
• The village is too remote and unable to execute the CIME model completely,
• The village has a government public health facility,
• The village has no mobile network coverage
• The village is in the ongoing armed conflict zone , or
• The village has an ICMV program operated by any organizations other than NMCP
• The village has an Annual Parasite Index (API) \>=5

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• National Malaria Control Program, Myanmar: collaborator

Related Publications (2)

• Win Han Oo, Htike W, May Chan Oo, Pwint Phyu Phyu, Kyawt Mon Win, Nay Yi Yi Linn, Tun Min, Ei Phyu Htwe, Aung Khine Zaw, Kaung Myat Thu, Galau NH, Cutts JC, Simpson JA, Scott N, O'Flaherty K, Agius PA, Fowkes FJI. Effectiveness of an expanded role for community health workers on malaria blood examination rates in malaria elimination settings in Myanmar: an open stepped-wedge, cluster-randomised controlled trial. Lancet Reg Health Southeast Asia. 2024 Oct 17;31:100499. doi: 10.1016/j.lansea.2024.100499. eCollection 2024 Dec.

  PMID: 39492851 DERIVED

• 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.

  PMID: 34389579 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Freya Fowkes, DPhil

  Burnet Institute

  PRINCIPAL INVESTIGATOR

• Win Han Oo, PhD

  Burnet Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Freya Fowkes, DPhil

CONTACT

+61385062310; freya.fowkes@burnet.edu.au

Win Han Oo, PhD

CONTACT

+951375785; winhan.oo@burnet.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized control trial (one-way crossover)

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Supporting information will be published in peer-reviewed journals within 2 years of study completion.
• Access Criteria: Supporting information can be requested from study investigators