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Last Updated: 07/02/2023

Malaria rapid diagnostic test capture and reporting assessment (MaCRA)

Objectives

The primary objective of the study is to measure agreement between health care worker and panel rapid diagnostic test results in Benin, Côte d’Ivoire, Nigeria and Uganda. 

The secondary objectives are as follows:

  1. Measure the statistical association between key characteristics of HCWs, RDT guidelines, health systems, malaria epidemiology and patient demographics and type of agreement/disagreement between the HCW and panel RDT results.
  2. Understand how characteristics of HCWs, RDT guidelines, health systems, malaria epidemiology and patient demographics affect the ability of HCWs to accurately implement, interpret, use, record and report RDT results.
  3. Assess the fidelity of data entry from health facility registers to the health management information system (HMIS).
  4. Determine the degree of over- and under- treatment for malaria and statistical associations with characteristics of HCWs, RDT guidelines, health systems, malaria epidemiology and patient demographics.
  5. Determine whether there is an observer impact of the study on monthly number of RDT positive results and TPRs.
  6. Determine the frequency of RDT anomalies that affect visual interpretation of results.
  7. Calculate the accuracy of HealthPulse (Audere, Seattle, WA), a smartphone-based application that uses artificial intelligence to interpret RDT results, compared to the panel RDT results after training on a random selection of RDT photographs.
  8. Determine the durability of RDT results over time by comparing agreement of RDT results read at one week and one month after administration with the initial read.
Rationale and Abstract

The Global Technical Strategy for Malaria 2016-2030 (GTS) upgraded surveillance (the collection, analysis and use of malaria data to plan, implement and evaluate programs) to a core intervention within national malaria strategies. While the elevation of surveillance as an intervention has corresponded with improvements in malaria surveillance, continued attention is needed to ensure that the information collected through routine surveillance systems is of sufficient quality to be useful in identifying areas and population groups that are most affected by malaria, planning interventions and monitoring progress over time in controlling and eliminating malaria. The accuracy of surveillance for malaria depends on the correct administration, interpretation, adherence, recording and reporting of rapid diagnostic test (RDT) results where RDTs are the predominant parasitological test. For case management, there is the additional consideration of HCW adherence to RDT results. Despite the accuracy and quality of RDTs and their expanding use in SSA, there remain persistent concerns over HCWs’ ability to correctly implement and interpret RDT results, the adherence of prescription practices to the results, and the fidelity of the recording and reporting of RDT results within the HMIS.

PMI Insights is conducting operations research in Benin, Cote d’Ivoire, Nigeria, and Uganda to measure the degree of agreement between RDT results as recorded in health facility registers and results determined by an independent, objective panel that will independently review high-quality photographs of the RDTs taken through a phone-based application. The study also seeks to identify factors at the level of the individual patient, healthcare worker, facility, transmission season and transmission setting that affect the type of agreement or disagreement between healthcare worker and panel RDT results. The study, led by local research partners in each of the four focus countries (listed below), will include a six-month observational study in peripheral health facilities; a knowledge, attitudes, practices, and behaviors (KAPB) survey with healthcare workers; and in-depth interviews with healthcare workers to further explore the factors that contribute to RDT administration and reporting practices.

Study Design

Mixed-methods, observational study of RDT results in peripheral health facilities in four countries.

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