Clinical trial NCT06804902: MaCRA Part B in Côte d'Ivoire
Official title: Improving the Accuracy of Malaria RDT Reporting in Public Primary Healthcare Facilities in Côte d'Ivoire
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malaria
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Institut National de Sante Publique
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 Cote d'Ivoire.

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
* District and regional health teams involved in the monthly RDT validation meetings from districts selected for the study.

Primary outcomes:
measure: The proportion of RDTs recorded as positive in healthcare facility registers.
timeFrame: Four months
Secondary outcomes:
measure: Ratio of TPR between healthcare facility registers and RDT cassettes in intervention facilities over time.
timeFrame: Four months
measure: Proportion of suspected patients tested by RDT who receive an antimalarial prescription.
timeFrame: Four months
measure: The total number of antimalarials.
timeFrame: Four months
measure: The cost required to implement the monthly RDT validation meetings.
timeFrame: Four months
measure: 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).
timeFrame: immediately after the intervention period
measure: Qualitative description of the acceptability and feasibility of conducting monthly RDT validations and using a digital tool (HealthPulse, Audere, Johannesburg, South Africa).
timeFrame: immediately after the intervention period
Other outcomes:
Locations:
city: Cities In Selected Districts
country: Côte D'Ivoire
facility: Health facilities in selected districts
Study officials:
affiliation: INSP
name: William Yavo
role: PRINCIPAL_INVESTIGATOR
References: