Clinical trial NCT04033640: Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil
Official title: Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: G6PD Deficiency
Keywords: G6PD deficiency
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
First posted: 2019-07-26
Enrollment: 1754
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Th objectives of this study are:

* To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay
* To assess the comprehension of the G6PD test packaging and labelling among intended users
* To assess the usability of G6PD test result outputs among intended users

Detailed description: This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants.

The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests.

The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.

Eligibility criteria: 1. Participants with unknown G6PD status

   Inclusion criteria:
   * Febrile patients seeking care at the Manaus or Porto Velho clinics
   * 2 years age or older
   * Willing to provide informed consent

   Exclusion criteria
   * Younger than 2 years of age
   * Participants who received a blood transfusion in the last 3 months, self report
   * Unwilling to provide informed consent
2. Participants with known G6PD status

   Inclusion criteria:
   * Included in previous G6PD surveys and provided consent to be contacted again
   * 2 years of age or older
   * Willing to provide informed consent or assent

   Exclusion criteria:
   * Younger than 2 years of age
   * Participants who received a blood transfusion in the last 3 months, self report
   * Unwilling to provide informed consent or assent or unavailable during study visit
3. Health workers

Inclusion Criteria:

* Provides malaria case management at study facility or study site
* Considered an intended user of quantitative POC G6PD tests
* Trained and proficient in the use of the POC G6PD test
* Willing to provide informed consent

Exclusion Criteria:

* Does not provide malaria case management at study facility or study site
* Not considered an intended user of quantitative POC G6PD tests
* Not trained or not proficient in the use of the POC G6PD test
* Unwilling to provide informed consent

Primary outcomes:
measure: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
timeFrame: All samples were collected on study day 1
measure: Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
timeFrame: All samples were collected on study day 1
Secondary outcomes:
measure: Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit
timeFrame: All samples were collected on study day 1
measure: Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test
timeFrame: All samples were collected on study day 1
measure: Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count
timeFrame: All samples were collected on study day 1
measure: Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples
timeFrame: All samples were collected on study day 1
measure: Number of Participants Who Met Acceptance Criteria for Label Comprehension
timeFrame: Day 1
measure: Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation
timeFrame: Day 1
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Tropical Medicine Foundation Doctor Heitor Vieira Dourado
state: Amazonas
city: Porto Velho
country: Brazil
facility: Centro de Pesquisa em Medicina Tropical de Rondônia
state: Rondônia
Study officials:
affiliation: FMT/HVD
name: Marcus Lacerda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zobrist S, Brito M, Garbin E, Monteiro WM, Clementino Freitas S, Macedo M, Soares Moura A, Advani N, Kahn M, Pal S, Gerth-Guyette E, Bansil P, Domingo GJ, Pereira D, Lacerda MV. Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil. PLoS Negl Trop Dis. 2021 Aug 12;15(8):e0009649. doi: 10.1371/journal.pntd.0009649. eCollection 2021 Aug.
citation: Gerth-Guyette E, Adissu W, Brito M, Garbin E, Macedo M, Sharma A, Das S, Lacerda MVG, Pereira D, Talukdar A, Yilma D, Pal S, Zobrist S, Domingo GJ. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation. Malar J. 2021 Jul 8;20(1):307. doi: 10.1186/s12936-021-03803-1.