MaCRA Part B in Nigeria

NCT ID: NCT06805110

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Monthly RDT validation during DHIS2 data review meetings

Intervention Type: 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.

Control

There will be no new activities in the control facilities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Sydani Group

UNKNOWN

Sponsor Role: collaborator

US President's Malaria Initiative

UNKNOWN

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunday Atobatele

Role: PRINCIPAL_INVESTIGATOR

Sydani Group

Other Identifiers

RES-00850

Identifier Type: -

Identifier Source: org_study_id