Clinical trial NCT05059457: Comparison of Blood Sampling Methods for Hemoglobin Measurement
Official title: A Pilot to Asses Hemoglobin Concentration Obtained From Capillary and Venous Blood Measured Using the HemoCue 201+ Hemoglobin Analyzer in a Controlled and Field Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: Anemia
DHS surveys
Point-of-care
Hemoglobin
Survey methods
Lead sponsor: ICF Macro, Inc.
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Uganda Bureau of Statistics
First posted: 2021-09-28
Enrollment: 1082
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be children 6-59 months and non-pregnant women 15-49 years. In the controlled setting, participants will be selected from nearby communities and brought to the Ebenezer Lab in Kampala, Uganda. In the field setting, participants will be selected from households eligible for the DHS-8 questionnaire pilot in districts located near Kampala, Uganda.

Brief summary: This study is designed to inform The DHS Program on whether there are variations in hemoglobin concentration using the DHS standard technique of a single drop of capillary blood and alternative blood sources (pooled capillary and venous blood) using the HemoCue 201+ analyzer compared to venous blood using a clinical hematology autoanalyzer.

Research Objectives:

1. To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) and a pooled drop of capillary blood measured on the HemoCue 201+ analyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled setting (i.e., blood specimens are collected in a laboratory setting).
2. To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
3. To determine if there are differences in the hemoglobin concentration between a pooled drop of capillary blood measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
4. To compare results of hemoglobin distribution and estimates of anemia prevalence using two types of capillary blood (single drop and pooled) and venous blood measured on the HemoCue 201+ analyzer and a clinical autoanalyzer using venous blood in a controlled and field setting.


Eligibility criteria: Inclusion Criteria:

* Children 6-59 months or non-pregnant women 15-49
* Apparently healthy individuals
* Consent to participate in the study

Exclusion Criteria:

* Children less than 6 months or over 59 months
* Women less than 15 years of age or greater than 49 years of age
* Pregnant women

Primary outcomes:
measure: Hemoglobin measurement
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Ebenezer Lab
city: Kampala
country: Uganda
facility: Uganda Bureau of Statistics
Study officials:
affiliation: ICF
name: Sorrel ML Namaste, DrPH
role: PRINCIPAL_INVESTIGATOR
References: