MaCRA Part B in Nigeria

Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Nigeria

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.

Study Overview

• Status: Withdrawn
• Conditions: Malaria
• Intervention / Treatment: Behavioral: Monthly RDT validation during DHIS2 data review meetings

Detailed Description

PMI Insights supported a multi-country evaluation of the accuracy of the recording and reporting of rapid diagnostic test (RDT) results at health facilities in Benin, Côte d'Ivoire, Nigeria, and Uganda (MaCRA Part A). The evaluation found a high degree of agreement between RDT results recorded in health facilities and an objective panel reading of the same RDTs. However, the changes in test positivity rate (TPR) after the start of the study suggest that some of this agreement may have been a result of the Hawthorne effect: in all countries except Benin, TPR declined after the start of the evaluation in facilities where evaluation staff were present, compared with control facilities. This suggests that the presence of evaluation staff caused health care workers to change their behavior with respect to reporting positive RDT results. The study evaluated the durability of RDT results and found that 95% of RDT cassettes retained their original reading over a one-month period. This provides evidence that stored RDT cassettes may be compared to health facility registers at monthly validation meetings, as long as a certain margin of error is used to account for the proportion of tests that may change.

The results from the first phase of the study were used to identify potential interventions to improve RDT reporting and recording accuracy in health facilities. The second phase of the study aims to evaluate the effectiveness of monthly district-level RDT result validation meetings on reducing the proportion of RDT results recorded as positive in health facility registers and reported to the national health management information system.

This is a two-arm cluster-randomized controlled effectiveness evaluation. Districts will serve as the clusters and will be assigned using restricted randomization to the intervention or control arm. In the intervention arm, the Ministry of Health will lead monthly district-level RDT validation meetings facilitated by a digital phone-based app which uses AI to record RDT results (HealthPulse, Audere, Johannesburg, South Africa). There will be no study activities in the control facilities.

Monthly RDT validation meetings will take place over a four-month period (April to July 2025), after which a cross-sectional survey and in- depth interviews will be conducted.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monthly RDT validation during DHIS2 data review meetings; 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; 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.
No Intervention: Control; There will be no new activities in the control facilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of TPR between health facility registers and RDT cassettes in intervention facilities over time.	The change in ratio will be measured by using the TPR from the facility registers and the TPR from the cassettes entered into the HealthPulse app	4 months (April - July 2025)
Total costs associated with monthly RDT validation exercises	Collection and analysis of cost data, including personnel costs, travel expenses, and other project-related expenses will be used to estimate the total costs associated with the validation meetings	4 months (April - July 2025)
HCWs subjective norms, attitudes, perceptions and practices regarding RDT usage	A questionnaire will be administered to HCWs in the intervention and control group to compare differences in their subjective norms, attitudes, perceptions and practices regarding RDT	Immediately after intervention period (August 2025)
Acceptability and feasibility of implementing monthly RDT validation exercises	In-depth interviews will be conducted with HCWs, local government areas (LGAs) and state officials to understand their perceptions of the acceptability of the monthly validation processes	Immediately after intervention period (August 2025)
Acceptability and feasibility of using a digital smartphone application for monthly RDT validation exercises	In-depth interviews will be conducted with HCWs, LGA and state officials to understand their perceptions of the acceptability and feasibility of using the digital application during monthly validation	Immediately after intervention period (August 2025)

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Bill and Melinda Gates Foundation; US President's Malaria Initiative; Sydani Group
• Investigators: Principal Investigator: Sunday Atobatele, Sydani Group

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria
• Other Study ID Numbers: RES-00850

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No