MaCRA Part B in Côte d'Ivoire

PATH

Status: Withdrawn

Conditions: Malaria

Treatments: Behavioral: Monthly RDT Validation Meeting

Study type: Interventional

Funder types: Other

Identifiers

NCT06804902

RES-00849

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

Health facilities in intervention districts will bring all RDT cassettes performed in their facility and all outpatient registers to a monthly data validation meeting led by the surveillance, monitoring and evaluation officers (CSE). During these meetings, Audere's HealthPulse application will be used to take photos of each facility's RDT cassettes, tallying the total number of RDTs and total by result. The test positivity rates (TPRs) from the registers will be manually entered into the application and compared with the TPR from the RDT photos. Healthcare facilities with a discrepancy above a certain threshold between TPR derived from register data and the TPR derived from the RDT images may be asked to carry out a more detailed audit to better understand the source of discrepant results. If discrepancies are identified, the CSE will determine what corrections are required before entry into the DHIS2.

Treatment:

Behavioral: Monthly RDT Validation Meeting

Control

No Intervention group

Description:

There will be no activities in the control arm.