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

NCT03394976 | Withdrawn

• 1 other identifier: HAT-malaria RDT evaluation
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human African Trypanosomiasis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

No intervention DIAGNOSTIC_TEST

No intervention

Study population

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Makerere University: collaborator
• Ministry of Public Health, Democratic Republic of the Congo: collaborator

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 9, 2018
• Study Start: January 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 9, 2024

Record last verified: 2024-01