Evaluating a novel diagnostic test for the detection of Plasmodium infections at community level in The Gambia and Burkina Faso

Not Applicable

• Conditions: Diagnosis of Plasmodium infection; Infections and Infestations

• Registration Number: ISRCTN15263932
• Lead Sponsor: MRC Unit The Gambia at LSHTM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Last Update Posted: 26 August 2024
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

1. >6 months of age
2. Present in the household at the time of the interviews
3. Consent to participate in the study (or consent given by an adult caregiver if <18 years old and assent for children =12 years old)

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Dragonfly in detecting Plasmodium infection at the time of recruitment assessed by comparing Dragonfly results against reference standard (PCR).

Secondary Outcome Measures

Name	Time	Method
1. Diagnostic accuracy of RDT in detecting Plasmodium infection at the time of recruitment by comparing RDT results against reference standard (PCR). <br>2. Diagnostic accuracy of microscopy in detecting Plasmodium infection at the time of recruitment by comparing microscopy results against reference standard (PCR). <br>3. Ease of use of Dragonfly assessed using qualitative interview guides within 4 weeks after presentation of Dragonfly technology to the potential users. <br>4. Factors influencing the uptake of community-based interventions such as mass testing and treatment assessed using qualitative interview guides within 6 months after the cross-sectional surveys.