Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria

A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively.

The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.

Study Overview

• Status: Withdrawn
• Conditions: Human African Trypanosomiasis
• Intervention / Treatment: Diagnostic test: No intervention

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.

The study will focus on passive screening, which is the intended use of the test.

Description

Inclusion Criteria:

• Age greater than or equal to 6 years
• Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.

Exclusion Criteria:

• Severe anaemia preventing collection of a sample of venous blood
• Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
• For HAT true negatives only: history of previous HAT infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.	Diagnostic test: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
specificity of the HAT/malaria combo test for gambiense HAT in passive screening	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening	Enrolment
sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening	Enrolment
sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening	Enrolment
specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening	Enrolment
specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening	Enrolment

Secondary Outcome Measures

Outcome Measure	Time Frame
specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic	Enrolment
specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic	Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic	Enrolment

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: Makerere University; Ministry of Public Health, Democratic Republic of the Congo

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Euglenozoa Infections; Malaria; Malaria, Falciparum; Trypanosomiasis; Trypanosomiasis, African
• Other Study ID Numbers: HAT-malaria RDT evaluation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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