NCT05059457

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. 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,082

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

September 17, 2021

Last Update Submit

March 28, 2022

Conditions

Anemia

Keywords

AnemiaDHS surveysPoint-of-careHemoglobinSurvey methods

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin measurement

    Difference (correlation, concordance, paired t-test) in hemoglobin concentration between each blood source measured with the HemoCue 201+ compared to venous blood measured with a clinical autoanalyzer.

    Day 1

Study Arms (3)

Controlled setting: single capillary and pooled capillary and venous blood

Single drop capillary blood, pooled capillary blood, and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a controlled setting.

Device: Blood source: single and pooled capillary and venous blood

Field setting: single capillary and venous blood

Single drop capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.

Device: Blood source: single capillary and venous blood

Field setting: pooled capillary and venous blood

Pooled capillary blood and venous blood will be collected and hemoglobin measured among non-pregnant women age 15-49 and children age 6-59 months in a field setting.

Device: Blood source: pooled capillary and venous blood

Interventions

Blood source: single and pooled capillary and venous bloodDEVICE

* A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+. * Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+. * Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Controlled setting: single capillary and pooled capillary and venous blood
Blood source: single capillary and venous bloodDEVICE

* A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+ . * Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Field setting: single capillary and venous blood
Blood source: pooled capillary and venous bloodDEVICE

* Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+. * Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer.

Field setting: pooled capillary and venous blood

Eligibility Criteria

Age6 Months - 49 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ebenezer Lab

Kampala, Uganda

Location

Uganda Bureau of Statistics

Kampala, Uganda

Location

Related Publications (1)

  • Namaste SM, Baingana R, Brindle E. Hemoglobin measurement in venous blood compared with pooled and single-drop capillary blood: a method-comparison study in a controlled and survey setting in Uganda among children and women. Am J Clin Nutr. 2024 Apr;119(4):949-959. doi: 10.1016/j.ajcnut.2023.12.025. Epub 2024 Jan 3.

    PMID: 38176682DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sorrel ML Namaste, DrPH

    ICF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

August 23, 2021

Primary Completion

September 26, 2021

Study Completion

September 26, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

UG(2)