Africa Ready Malaria Screening (ARMS)

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

Study Overview

• Status: Active, not recruiting
• Conditions: Malaria
• Intervention / Treatment: Diagnostic test: Immuno analytical assay

Detailed Description

In this study, immuno-analytical assays will be developed for determining the titres of malaria antibodies in sera of two groups (malaria patients and donors/healthy volunteers) using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens. Individuals in the two groups presenting to Shai-Osudoku District hospital will be screened for signs and symptoms of malaria according to the WHO criteria. Those within the inclusion and exclusion criteria will be introduced to the study through informed consent for adults (18 years and over) or parents/guardians for children below 12 years and assent for adolescents between 12 and below 18 years, along with informed consent from their parents. Enrolled study participants' demographic data and vital signs will be captured electronically onto the CRF. Patients will have their clinical history and detailed physical examination done by the study clinicians and then be sent to the laboratory for investigations to confirm the malaria diagnosis. The results of patients will be communicated to the study clinician to commence the appropriate treatment. At the of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection.

• Study Type: Interventional
• Enrollment (Actual): 1640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Outside North America
    • Dodowa, Outside North America, Ghana, GAR
      • Shai-Osudoku District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with confirmed malaria (uncomplicated and complicated cases) are diagnosed by the national guidelines.
• Healthy individuals without confirmed malaria per the national guidelines.
• Adults and parents or guardians of children below 12 years willing to participate based on signed informed consent.
• Willing to give assent to adolescents between the ages of 12 and below 18 years.
• Willing to give a blood sample for the necessary investigations as explained in the informed consent.
• Willing to adhere to study procedures and a follow-up visit at the clinic, hospital, or health facility.

Exclusion Criteria:

• Anyone refusing informed consent (or assent for adolescents) to be part of the study.
• Refusal to study procedures or giving of sample for the necessary investigations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Malaria patients	Diagnostic test: Immuno analytical assay; The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.
Active Comparator: Non malaria donors; Healthy individuals (donors; controls)	Diagnostic test: Immuno analytical assay; The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSP1-19 malaria antigen	Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-MSP1-19 malaria antibody	Number of participants with antiMSP1-19 malaria antibody as assessed by a lateral flow test kit.	three years

Collaborators and Investigators

• Sponsor: University of Ghana
• Collaborators: University of Rostock; Shai-Osudoku District Hospital; Kumasi Technical University; University of Applied Sciences Bonn-Rhein-Sieg; Hochschule Aalen
• Investigators: Study Director: Adjei, Shai-Osudoku District Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Estimated): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: GHS-ERC: 009/06/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be deposited in Zenodo's open data repository service (CERN). Additionally, all datasets will be stored on external drives and in-house computers. The data will be deposited as soon as possible unless there is a legitimate reason and a decision has been agreed upon to protect the data. Before the upload of datasets, a unique DOI will be assigned, which will be stated in publications to direct readers to the primary datasets. Due to the public health interest of the outcome of this work, the datasets will be shared directly with relevant stakeholders for a wider public audience. There will be restricted datasets on the subject partaking in the study to protect their identity. This restriction will not affect the dissemination of the research outputs to the broader public. Although the datasets will be stored in the Zenodo repository for long-term preservation, the in-house datasets will be stored on an external drive for additional long-term benefit.
• IPD Sharing Time Frame: Five years
• IPD Sharing Access Criteria: The IPD can be accessed by requesting the Principal Investigator or accessing the information directly from Zenodo's open data repository service.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No