MaCRA Part B in Côte d'Ivoire

NCT06804902 | Withdrawn DMC

• 1 other identifier: RES-00849
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (RDT) validation meetings at district level on reducing the proportion of RDT results recorded as positive in health facility registers in Cote d'Ivoire.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• The proportion of RDTs recorded as positive in healthcare facility registers.

  Data will be collected from the DHIS2 after the end of the study for both control and intervention arms.

  Four months

Secondary Outcomes (6)

• Ratio of TPR between healthcare facility registers and RDT cassettes in intervention facilities over time.

  Four months

• Proportion of suspected patients tested by RDT who receive an antimalarial prescription.

  Four months

• The total number of antimalarials.

  Four months

• The cost required to implement the monthly RDT validation meetings.

  Four months

• Proportion of healthcare workers reporting compliance with negative RDT results when patients present with fever (i.e. recording the RDT result as negative, not recording the case as malaria and not prescribing antimalarial medication).

  immediately after the intervention period

Study Arms (2)

Intervention

EXPERIMENTAL

Health facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2.

Behavioral: Monthly RDT Validation Meeting

Control

NO INTERVENTION

There will be no activities in the control arm.

Interventions

Monthly RDT Validation Meeting BEHAVIORAL

Health facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2.

Intervention

Eligibility Criteria

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

You may qualify if:

• Healthcare workers responsible for testing or interpreting malaria RDTs in the selected study facilities
• District and regional health teams involved in the monthly RDT validation meetings from districts selected for the study.

Sponsors & Collaborators

• PATH: lead
• Bill and Melinda Gates Foundation: collaborator
• Institut National de Sante Publique: collaborator
• US President's Malaria Initiative: collaborator

Study Sites (1)

Health facilities in selected districts

Cities in Selected Districts, Côte d’Ivoire

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• William Yavo

  INSP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 3, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CÔ (1)