Clinical trial NCT06805110: MaCRA Part B in Nigeria
Official title: Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Nigeria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malaria
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Sydani Group
name: US President's Malaria Initiative
First posted: 2025-02-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The proportion of RDT results reported as positive from study facilities on the DHIS2
timeFrame: 4 months (April - July 2025)
Secondary outcomes:
measure: Ratio of TPR between health facility registers and RDT cassettes in intervention facilities over time.
timeFrame: 4 months (April - July 2025)
measure: Total costs associated with monthly RDT validation exercises
timeFrame: 4 months (April - July 2025)
measure: HCWs subjective norms, attitudes, perceptions and practices regarding RDT usage
timeFrame: Immediately after intervention period (August 2025)
measure: Acceptability and feasibility of implementing monthly RDT validation exercises
timeFrame: Immediately after intervention period (August 2025)
measure: Acceptability and feasibility of using a digital smartphone application for monthly RDT validation exercises
timeFrame: Immediately after intervention period (August 2025)
Other outcomes:
Locations:
Study officials:
affiliation: Sydani Group
name: Sunday Atobatele
role: PRINCIPAL_INVESTIGATOR
References: