Trial Outcomes & Findings for TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI) (NCT NCT03948698)

NCT ID: NCT03948698

Last Updated: 2023-04-18

Results Overview

Number and proportion of children (age 0-14) screened for TB among clinic attendees

Recruitment status

COMPLETED

Target enrollment

4159533 participants

Primary outcome timeframe

December 2018-September 2021

Results posted on

2023-04-18

Participant Flow

This study does not have a set number of participants. The number of participants is number of children screened.

Participant milestones

Participant milestones
Measure	CaP TB TIPPI Study No new information to report
Overall Study STARTED	4749072
Overall Study COMPLETED	4749072
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CaP TB TIPPI Study n=2318 Participants No new information to report
Age, Categorical <=18 years	2318 Participants n=2318 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=2318 Participants
Age, Categorical >=65 years	0 Participants n=2318 Participants
Sex: Female, Male Female	1163 Participants n=2318 Participants
Sex: Female, Male Male	1155 Participants n=2318 Participants
Region of Enrollment Cameroon	159 participants n=2318 Participants
Region of Enrollment Malawi	167 participants n=2318 Participants
Region of Enrollment Côte D'Ivoire	247 participants n=2318 Participants
Region of Enrollment Congo, The Democratic Republic of the	709 participants n=2318 Participants
Region of Enrollment Tanzania	335 participants n=2318 Participants
Region of Enrollment Uganda	92 participants n=2318 Participants
Region of Enrollment Zimbabwe	281 participants n=2318 Participants
Region of Enrollment Kenya	212 participants n=2318 Participants
Region of Enrollment Lesotho	116 participants n=2318 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: The number of participants analyzed, 7198865, is the clinic attendees and 4749072 is number of children screened. 4749072 is the number indicated in the participant flow because this data is generated by the study. Clinic attendees data is already available in health facilities.

Number and proportion of children (age 0-14) screened for TB among clinic attendees

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=7198865 Participants No new information to report
Children Screened for TB	4749072 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: The number Started in the participant flow was revised and both values are equal

Among those screened the number and proportion of children presumed to have TB.

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=4749072 Participants No new information to report
Children With Presumptive TB	60250 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number and proportion of presumptive TB cases referred for lab-based TB diagnosis

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=60250 Participants No new information to report
Children With Presumptive TB Referred for Lab-based TB Diagnosis	49022 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=60250 Participants No new information to report
Children With Presumptive TB Tested Using GeneXpert	35554 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=36026 Participants No new information to report
Children Initiated on TB Preventive Therapy	28762 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: Please note the number this measure is different than the one indicated for Children Initiation on PT because here we report Children that were initiated on PT with expected outcomes (i.e. 6 months of preventive therapy)

Number and proportion of pediatric patients on preventive treatment who completed therapy

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=28762 Participants No new information to report
Children Completing TB Preventive Therapy	22590 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number of pediatric cases diagnosed with active TB disease among children with presumptive TB

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=60250 Participants No new information to report
Children Diagnosed With Active TB	11078 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number and proportion of pediatric TB cases started on DS-TB treatment

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=11078 Participants No new information to report
Children Initiated on TB Treatment	10834 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: Please note that this measure if different than the one reported in Children initiated in DS TB treatment because this number only includes children with expected treatment outcomes (i.e completing 6 months treatment)

Number and proportion of pediatric DS-TB cases who achieve treatment success

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=7221 Participants No new information to report
Children Achieving Treatment Success	6553 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Number and proportion of all TB index cases for whom successful contact tracing has been done

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=63314 Participants No new information to report
TB Contacts Successfully Traced	20998 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: The overall number of participants analyzed here would be the number of contacts screened.

Number and proportion of pediatric household contacts who are negative to TB screening

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=48907 Participants No new information to report
TB Contacts Screened Negative for TB	37774 Participants

PRIMARY outcome

Timeframe: December 2018-September 2021

Population: Please note that these numbers will differ from the numbers reported on previous measures related to preventive therapy because these numbers only include contact tracing whereas previously reported measures included both TB contacts and people coming from HIV clinics

Number and proportion of screened negative pediatric contacts eligible for preventive therapy

Outcome measures

Outcome measures
Measure	CaP TB TIPPI Study n=37774 Participants No new information to report
TB Contacts Eligible for Preventive Therapy	19630 Participants

Adverse Events

CaP TB TIPPI Study

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

Shirin Kakayeva

Elizabeth Glaser Pediatric AIDS Foundation

Phone: 2404377929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place