MaCRA Part B in Nigeria

NCT06805110 | Withdrawn

• 1 other identifier: RES-00850
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 Nigeria.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• The proportion of RDT results reported as positive from study facilities on the DHIS2

  Data for the intervention and control facilities will be downloaded from the DHIS2 at the end of August 2025

  4 months (April - July 2025)

Secondary Outcomes (5)

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

  4 months (April - July 2025)

• Total costs associated with monthly RDT validation exercises

  4 months (April - July 2025)

• HCWs subjective norms, attitudes, perceptions and practices regarding RDT usage

  Immediately after intervention period (August 2025)

• Acceptability and feasibility of implementing monthly RDT validation exercises

  Immediately after intervention period (August 2025)

• Acceptability and feasibility of using a digital smartphone application for monthly RDT validation exercises

  Immediately after intervention period (August 2025)

Study Arms (2)

Monthly RDT validation during DHIS2 data review meetings

EXPERIMENTAL

The Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records.

Behavioral: Monthly RDT validation during DHIS2 data review meetings

Control

NO INTERVENTION

There will be no new activities in the control facilities.

Interventions

Monthly RDT validation during DHIS2 data review meetings BEHAVIORAL

The Nigeria national malaria program will lead monthly RDT validation at selected legal government areas (LGAs). Health facilities will be asked to retain all RDT cassettes performed for the prior month and bring them to a monthly validation meeting. During these meetings, RDT cassettes will be scanned using the HealthPulse application, which will automatically tally the number of RDTs by brand and result. The application will also allow for the entry of aggregated testing data, including the total number of tests conducted and the RDT results recorded in the health facility register. Discrepancies between the HealthPulse data and facility records will be calculated, with a focus on identifying and addressing discrepancies exceeding a designated threshold (e.g., 10%) that takes into account the proportion of cassettes that may have changed results over the past month. Facilities with significant discrepancies may undergo a detailed audit to align RDT cassettes with patient records.

Monthly RDT validation during DHIS2 data review meetings

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
• LGA health teams involved in the monthly RDT validation meetings from LGAs selected for the study.

Sponsors & Collaborators

• PATH: lead
• Bill and Melinda Gates Foundation: collaborator
• Sydani Group: collaborator
• US President's Malaria Initiative: collaborator

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Sunday Atobatele

  Sydani Group

  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