Scaling up Evidence Based Multiple focus Integrated Intensified TB Screening to End TB (EXIT-TB) in the East African region.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201805003200287
• Date of registration: 15/03/2018
• Prospective Registration: Yes
• Primary sponsor: European and Developing Countries Clinical Trial Partnerships
• Public title: Scaling up Evidence Based Multiple focus Integrated Intensified TB Screening to End TB (EXIT-TB) in the East African region.
• Scientific title: Implementation and evaluation of Evidence Based Multiple focus Integrated Intensified TB Screening to End TB (EXIT-TB) in the East African region in increasing TB case detection in the East African region.
• Date of first enrolment: 01/08/2018
• Target sample size: 35831
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3200
• Study type: Interventional
• Study design: Crossover: all participants receive all interventions in different sequence during study,Randomised,Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification),Allocation was determined by the holder of the sequence who is situated off site
• Phase: Not Applicable

Countries of recruitment

Ethiopia, Kenya, Sudan, Tanzania, Uganda

Contacts

• Name: Esther Ngadaya
• Affiliation: Prinicpal Research Scientist

• Name: Godfather Kimaro
• Affiliation: Senior Research Scientist

Key inclusion & exclusion criteria

Inclusion criteria: All consented individuals who passively report a cough at OPD and RCH regardless of the duration;
HIV infected individuals with advanced diseases attending CTC irrespective of TB symptoms;
Symptomatic diabetic patients attending diabetic clinics;
Symptomatic children with a household member with TB.
Exclusion criteria: Non consented patients;
Asymptomatic patients at OPD and RCH;
HIV infected individuals with CD4 ¿ 200 cells/mm3 and/or WHO stage 1 or 2.

Age minimum: 1 Day(s)
Age maximum: 100 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Tuberculosis

Intervention(s)

Targeted contact tracing for all TB patients with child household members

Integrated TB Case finding.

Intensified passive TB case finding

Primary Outcome(s)

Number of TB cases notified

Secondary Outcome(s)

Number of TB patients put into TB care

Number of Deaths

Enabling and barrier factors including patients and health system cost

Number of TB suspects registered

Number of hospital attendances and admissions

Pattern of re-organization of staffs roles

Proportion of healthcare workers, policy makers and clients who accepted the model

Time from symptoms to diagnosis

Treatment outcome including death

Secondary ID(s)

NIMR/HQ/R.8a/Vol.IX/2629

Source(s) of Monetary Support

2nd European and Developing Countries Clinical Trial Partnerships(EDCTP2)

Ethics review

Status: Approved
Approval date: 15/01/2017
Contact:

Kilimanjaro Christian Medical College Research Ethics and Review Committee

Status: Approved
Approval date: 13/11/2017
Contact:

National Health Research Ethics Sub-Committee(NatHREC)

Status: Approved
Approval date: 06/04/2018
Contact:

Kenya Medical Research Institute Scientific and Ethics Review Unit