Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003200287 Date of Registration: 15/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Scaling up Evidence Based Multiple focus Integrated Intensified TB Screening to End TB (EXIT-TB) in the East African region.
Official 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.
Brief summary describing the background and objectives of the trial Tuberculosis (TB) remains a major cause of morbidity and mortality in sub-Saharan Africa. The high burden is mainly attributed to low case detection and delayed diagnosis. Country surveys showed unacceptable high prevalence of confirmed TB even among those with a low duration cough and more than 50% of those with prevalent bacteriologically confirmed pulmonary TB do not report symptoms that correspond to presumptive TB. Furthermore, there is an increase in incidence of smear negative pulmonary TB patients who can serve as source of infection.We are seeking to accelerate the translation of research into policy and practice through Evidence Based Multiple focus Integrated Intensified TB Screening package (EXIT-TB). The EXIT-TB package will involve intensified passive TB case finding (screening all patients at the Outpatient department who passively report any cough irrespective of duration); integrating TB case finding activities into reproductive and child health clinics (RCH) and diabetics clinics; screening for TB irrespective of symptoms among HIV/AIDS infected individuals with advanced diseases attending Care and Treatment Centres, and targeted contact tracing for all TB patients with child household members.Objectives include:To determine effectiveness of scaling up EXIT-TB package in increasing TB case detection, reducing TB diagnostic and treatment delays and improving TB treatment outcomes when implemented on a large scale in the East African region;To determine feasibility of scaling up the implementation of EXIT-TB package in routine health system;To inform and refine guidelines on TB diagnosis in HIV/AIDS, RCH and diabetic management services;To describe, using simple auditing of procedures and observations, the challenges faced by health services in delivering EXIT-TB package;To determine the cost effectiveness of EXIT-TB package implementation in urban and rural settings;To determine barriers to scaling-up EXIT-TB package in urban and rural settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EXIT TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 01/08/2021
Actual Last follow-up date 01/08/2021
Anticipated target sample size (number of participants) 35831
Actual target sample size (number of participants) 35831
Recruitment status Not yet recruiting
Publication URL http://www.exit-tb.org/
Secondary Ids Issuing authority/Trial register
NIMR/HQ/R.8a/Vol.IX/2629 CSA2016S-1608 ¿ EXIT-TB
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Integrated TB Case finding. Non applicable One year Testing for TB irrespective of symptoms among HIV clinics attendees with advanced diseases and diabetic clinics using GeneXpert 5374
Experimental Group Targeted contact tracing for all TB patients with child household members Non applicable One year Conducting household contact tracing of children with a household member with TB and perform symptoms screening followed by CXR and subject to further diagnostic test symptomatic and/or abnormal CXR children. 1792
Experimental Group Intensified passive TB case finding Non applicable One year Screening for TB all individuals who passively report a cough at Outpatient Department and Reproductive Child Health using Chest X-Ray(CXR). Those with abnormal CXR will be subjected to either GeneXpert or sputum smear microscopy depending on the availability 28665
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Non consented patients; Asymptomatic patients at OPD and RCH; HIV infected individuals with CD4 ¿ 200 cells/mm3 and/or WHO stage 1 or 2. 1 Day(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/11/2017 National Health Research Ethics Sub-Committee(NatHREC)
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, 11101 Dar es Salaam, Tanzania. Dar es Salaam P.O. Box 9653, Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/01/2017 Kilimanjaro Christian Medical College Research Ethics and Review Committee
Ethics Committee Address
Street address City Postal code Country
KCM College Opposite Tumaini Restaurant & New Admin Building Kilimanjaro P.O.Box 2240 Moshi Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/04/2018 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Nairobi P.O.Box 54840-00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of TB cases notified 12 months
Secondary Outcome Number of TB suspects registered 12 months
Secondary Outcome Number of TB patients put into TB care 12 months
Secondary Outcome Number of hospital attendances and admissions 12 months
Secondary Outcome Number of Deaths 12 months
Secondary Outcome Time from symptoms to diagnosis 12 months
Secondary Outcome Treatment outcome including death 12 months
Secondary Outcome Proportion of healthcare workers, policy makers and clients who accepted the model 12 months
Secondary Outcome Pattern of re-organization of staffs roles 12 months
Secondary Outcome Enabling and barrier factors including patients and health system cost 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bagamoyo District Hospital Bagamoyo Pwani P.O.Box 2236 Tanzania
Mkuranga District Hospital Mkuranga Pwani P.O.Box 3436 Tanzania
Ukwala Sub-County Hospital Ugenya Siaya P.O.Box 54840 0020 Kenya
Akala Health Centre Ndoli Siaya P.O.Box 54840 0020 Kenya
Bar Ndege Dispensary Kathieno B Siaya P.O.Box 54840 0020 Kenya
Tingare Dispensary Tingare East Siaya P.O.Box 54840 0020 Kenya
Naya Health Centre Naya Siaya P.O.Box 54840 0020 Kenya
Mulago Hospital Mulagi Hill Kampala P.O.Box 22418 Kenya
Kawaala Health Center Kawaala Kampala P.O. Box 22418 Uganda
Kiswa Health Center Kataza CI Kampala P.O. Box 22418 Uganda
Naguru Hospital Naguru Hill Kampala P.O.Box 22418 Uganda
Mukono Health Center  Mukono Kampala P.O. Box 22418 Uganda
Namayumba Health Center Namayumba Busiro P.O. Box 22418 Uganda
Nakaseke Hospital Nakaseke Nakaseke P.O.Box 22418 Uganda
Umdurman Maternity Hospital Morada Omdurman P.O.Box 114613 Sudan
Khartoum Diabeties Centre Khartoum Khartoum P.O.Box 114613 Sudan
Bashair HIV Treatment Centre Khartoum Khartoum P.O.Box 114613 Sudan
Gadarif Hospital Gedarif Gedarif P.O.Box 114613 Sudan
Gaber Abu Elez Diabetes Centre Khartoum Khartoum P.O.Box 114613 Sudan
Undueman Hospital Morada Omdurman P.O.Box 114613 Sudan
Gadaref Maternity Centre Gedarif Gedarif P.O.Box 114613 Sudan
Zewditu Memorial Hospital Region 14 Addis Ababa P.O.Box 1005 Ethiopia
ALERT Hospital (All Africa Leprosy, Tuberculosis and Rehabilitation Training Center) Zenebe work area Addis Ababa P.O.Box 1005 Ethiopia
Bole woreda 17 Health center Woreda 17 Addis Ababa P.O.Box 1005 Ethiopia
Kazanchis Health Center Addis Ababa Addis Ababa P.O.Box 1005 Ethiopia
Kilimanjaro Christian Medical Centre Hospital Longuo Kilimanjaro P.O.Box 2236 Tanzania
Mwananyamala Hospital Igusure Dar es Salaam P.O.Box 3436 Tanzania
Mbagala Rangi Tatu Hospital Mbagala Dar es Salaam P.O.Box 3436 Tanzania
Majengo Health Centre Mill Kilimanjaro P.O.Box 2236 Tanzania
Amana Regional Referral Hospital Uhuru Dar es Salaam P.O.Box 3436 Tanzania
Siaya County Referral Hospita Alego Siaya P.O. Box 54840 Kenya
Bondo Sub-County Hospital Bondo Siaya P.O.Box54840 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
2nd European and Developing Countries Clinical Trial Partnerships(EDCTP2) Anna van Saksenlaan 51,2593 HW The Hague,The Netherlands The Hague PO Box 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor European and Developing Countries Clinical Trial Partnerships Anna van Saksenlaan 51,2593 HW The Hague,The Netherlands The Hague PO Box 93015 Netherlands Funding Agency
Primary Sponsor Liverpool School of Tropical Medicine (LSTM) Pembroke Place Liverpool, L3 5QA Liverpool +44 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Kisumu Kisumu P.O. Box 1578-40100 Kenya
Institute of Endemic Disease Medical Sciences Campus, Qasser Street Khartoum P.O.Box 11463 Sudan
Centre for International Health, University of Bergen Overlege Danielsens Hus, Bergen Arstadveien 21,5020 Norway
Makerere Lung Institute Mulago Hill Kampala P.O.Box 7072 Uganda
Infectious disease Institute Mulago Hill Kampala P.O.Box 22418 Uganda
Amaeur Hansen Research Institute Jimma Road,ALERT Compound Addis Ababa P.O.Box 1005 Ethiopia
Kilimanjaro Clinical Research Institute Longuo Kilimanjaro P.O.Box 2236 Tanzania
Liverpool School of Tropical Medicine (LSTM) Pembroke Place Liverpool Liverpool L3 5QA UK United Kingdom
University College London Roowland Hill Street London London NW3 2PF United Kingdom
University of Bergen Centre for International Health Overlege Danielsens Hus, Bergen Arstadveien 21,5020 Norway
National Institute of Medical Research-Muhimbili Medical Research Centre Haile Debas Centre for Health Professions Education (HDCHPE) at Muhimbili University of Health and Allied Sciences (MUHAS) Campus,4th Floor Dar es Salaam P.O.Box 3436 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esther Ngadaya engadaya@yahoo.com +255784600118 Muhimbili University of Health and Allied Sciences (MUHAS) Campus,4th Floor
City Postal code Country Position/Affiliation
Dar es Salaam 3436 Tanzania Prinicpal Research Scientist
Role Name Email Phone Street address
Public Enquiries Godfather Kimaro fatherdk@yahoo.com +255784607461 Muhimbili University of Health and Allied Sciences (MUHAS) Campus,4th Floor
City Postal code Country Position/Affiliation
Dar es Salaam 3436 Tanzania Senior Research Scientist
Role Name Email Phone Street address
Public Enquiries Esther Ngadaya engadaya@yahoo.com +255784600118 Muhimbili University of Health and Allied Sciences (MUHAS) Campus,4th Floor
City Postal code Country Position/Affiliation
Dar es Salaam 3436 Tanzania Prinicpal Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Sayoki Mfinanga gsmfinanga@yahoo.com +255784755632 Muhimbili University of Health and Allied Sciences (MUHAS) Campus,4th Floor
City Postal code Country Position/Affiliation
Dar es Salaam 3436 Tanzania Chief Research Scientist
REPORTING
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