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Universal Screening for Tuberculosis and Anemia With the CHICA System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322841
First Posted: March 25, 2011
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
Results First Submitted: November 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Conditions: Tuberculosis
Iron Deficiency Anemia
Interventions: Other: CHICA Diagnosis Module
Other: CHICA Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CHICA Diagnosis Module This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
CHICA Placebo This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module

Participant Flow:   Overall Study
    CHICA Diagnosis Module   CHICA Placebo
STARTED   1116   1123 
COMPLETED   1116   1123 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CHICA Diagnosis Module This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
CHICA Placebo This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
Total Total of all reporting groups

Baseline Measures
   CHICA Diagnosis Module   CHICA Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1116   1123   2239 
Age 
[Units: Participants]
     
<=18 years   1116   1123   2239 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   538   542   1080 
Male   578   581   1159 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   2   0   2 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   21   27   48 
Black or African American   394   397   791 
White   679   662   1341 
More than one race   0   0   0 
Unknown or Not Reported   20   37   57 


  Outcome Measures
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1.  Primary:   Percentage of Patients Screened Positive for One of the Disorders   [ Time Frame: six months ]

2.  Secondary:   Percentage of Patients Diagnosed With One of the Disorders   [ Time Frame: six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aaron Carroll
Organization: Indiana University School of Medicine
phone: 3172789616
e-mail: aaecarro@iu.edu



Responsible Party: Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier: NCT01322841     History of Changes
Other Study ID Numbers: CHICA_Screening
5K22LM009160 ( U.S. NIH Grant/Contract )
First Submitted: March 23, 2011
First Posted: March 25, 2011
Results First Submitted: November 17, 2015
Results First Posted: December 18, 2015
Last Update Posted: December 2, 2016