Trial Outcomes & Findings for Universal Screening for Tuberculosis and Anemia With the CHICA System (NCT NCT01322841)

NCT ID: NCT01322841

Last Updated: 2016-12-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2239 participants
• Primary outcome timeframe: six months
• Results posted on: 2016-12-02

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	1116	1123
Overall Study COMPLETED	1116	1123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Universal Screening for Tuberculosis and Anemia With the CHICA System

Baseline characteristics by cohort

Measure	CHICA Diagnosis Module n=1116 Participants 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 n=1123 Participants This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module	Total n=2239 Participants Total of all reporting groups
Age, Categorical <=18 years	1116 Participants n=5 Participants	1123 Participants n=7 Participants	2239 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	538 Participants n=5 Participants	542 Participants n=7 Participants	1080 Participants n=5 Participants
Sex: Female, Male Male	578 Participants n=5 Participants	581 Participants n=7 Participants	1159 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) Black or African American	394 Participants n=5 Participants	397 Participants n=7 Participants	791 Participants n=5 Participants
Race (NIH/OMB) White	679 Participants n=5 Participants	662 Participants n=7 Participants	1341 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	37 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: six months

Outcome measures

Measure	CHICA Diagnosis Module n=1116 Participants 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 n=1123 Participants This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
Percentage of Patients Screened Positive for One of the Disorders TB	1.8 percentage of participants	0.8 percentage of participants
Percentage of Patients Screened Positive for One of the Disorders Iron Deficiency	17.5 percentage of participants	3.1 percentage of participants

SECONDARY outcome

Timeframe: six months

Outcome measures

Measure	CHICA Diagnosis Module n=1116 Participants 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 n=1123 Participants This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
Percentage of Patients Diagnosed With One of the Disorders Iron Deficiency Anemia	0.3 percentage of participants	0 percentage of participants
Percentage of Patients Diagnosed With One of the Disorders TB	0.2 percentage of participants	0 percentage of participants

Adverse Events

CHICA Diagnosis Module

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CHICA Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Carroll

Indiana University School of Medicine

Phone: 3172789616

Email: aaecarro@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place