MaCRA Part B in Côte d'Ivoire

Not Applicable

Withdrawn

• Conditions: Malaria

• Registration Number: NCT06804902
• Lead Sponsor: PATH

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.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Study Start: 2025-04
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 231

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of RDTs recorded as positive in healthcare facility registers.	Four months	Data will be collected from the DHIS2 after the end of the study for both control and intervention arms.

Secondary Outcome Measures

Name	Time	Method
Ratio of TPR between healthcare facility registers and RDT cassettes in intervention facilities over time.	Four months	The TPR for RDT cassettes will be collected from each healthcare facility by the HealthPulse application during monthly RDT validation meetings. The ratio will be calculated with these data, and the TPRs calculated from DHIS2.
Proportion of suspected patients tested by RDT who receive an antimalarial prescription.	Four months	For both the intervention and control arms, data on ACT prescription will be downloaded from the DHIS2 after the end of the study.
The total number of antimalarials.	Four months	For both arms, ACT prescription data will be downloaded from the DHIS2, and ACT consumption data from the integrated electronic logistics management system (e-SIGL) after the end of the study.
The cost required to implement the monthly RDT validation meetings.	Four months	This estimate will be made by recording the cost of training, the cost of smartphones and communication time, the number and categories of staff needed to plan and implement the monthly data validation meetings, as well as their travel expenses and per diems for attending the meeting. The costs of any follow-up activities will be noted. The time spent by different categories of staff will be tracked to provide an estimate of the level of effort required to implement the monthly validation meetings.
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).	immediately after the intervention period	Subjective norms, attitudes and practices towards RDTs will be measured in a cross-sectional survey of healthcare workers in selected facilities at the end of the study.
Qualitative description of the acceptability and feasibility of conducting monthly RDT validations and using a digital tool (HealthPulse, Audere, Johannesburg, South Africa).	immediately after the intervention period	The acceptability and feasibility of the monthly RDT validation exercise, as well as perceptions of the digital tools used for RDT validation, will be measured through in-depth interviews with health facility staff, district epidemiological surveillance and monitoring and evaluation (CSE) officers and malaria focal points.

Trial Locations

Locations (1)

Health facilities in selected districts; 🇨🇮 Cities In Selected Districts, Côte D'Ivoire