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.: PACTR202405534532698 Date of Approval: 02/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of two screening algorithms for tuberculosis among people with clinical risk factors who attend health facilities in Cameroon: a pragmatic cluster-randomized trial
Official scientific title Comparison of two screening algorithms for tuberculosis among people with clinical risk factors who attend health facilities in Cameroon: a pragmatic cluster-randomized trial
Brief summary describing the background and objectives of the trial More than 30% of people with TB globally and approximately 50% of people with TB in Cameroon are never diagnosed and linked to care for the disease. Evidence shows that the health system often either entirely misses or delays diagnosis for many people with TB who present to health facilities. Systematic screening for TB has the potential to increase the detection of TB and facilitate earlier diagnosis. Important clinical risk factors for TB among people attending health facilities include undernutrition, diabetes, smoking, alcohol use disorders and pregnancy. As part of an intervention to improve TB case finding in Cameroon, people with presumptive TB attending health centers in six regions of the country are being systematically screened for TB. In this add-on evaluation, we aim to compare the performance of systematic screening by pooled rapid molecular testing to TB symptom screening in a subset of people with clinical risk factors of TB. Screening with rapid molecular testing may provide better accuracy than screening with symptoms in many situations but requires more resources. Using pooled rather than individual testing reduces the resources needed for molecular testing and increases the feasibility of implementation, especially in resource-limited settings. This is a pragmatic, parallel, two-arm, cluster-randomized evaluation of two clinical screening algorithms among people with clinical risk factors for TB attending health facilities. The unit of randomization (cluster) will be the health facilities (an estimated 46 DTCs). The unit of analysis will be people attending health facilities who are screened for TB (an estimated 72,000 people). The primary objective is to evaluate the performance of two clinical screening approaches, symptom screening and rapid molecular screening, for TB among people with clinical risk factors of TB attending health facilities.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 72000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the 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 Screening for TB with molecular testing 2 hours (time to perform TB test) People with one or more clinical risk factors of TB (including diabetes, undernutrition, tobacco use, alcohol use disorder, HIV) and people who are pregnant will be offered TB screening with sputum molecular testing using the Xpert MTB/RIF Ultra assay 36000
Control Group Screening for TB with symptoms 2 hours (2 minutes for symptom screening + 2 hours for TB test if indicated) People with one or more clinical risk factors of TB (including diabetes, undernutrition, tobacco use, alcohol use disorder, HIV) and people who are pregnant will be offered TB screening with the WHO symptom screen for TB (cough, fever, night sweats, weight loss) 36000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for sites (clusters): Provide diagnosis and treatment for TB under supervision of the National TB Program Inclusion criteria for individuals: People who initiate evaluation for TB at an intervention site Exclusion criteria for sites (clusters): Site administration does not agree for site to participate and be randomized to one of the two interventions for enhanced screening of TB Site treated fewer than 20 people for TB each year (average of last 3 years) Sites are not readily accessible for supervision Exclusion criteria for individuals: People currently on TB treatment People currently on tuberculosis preventive treatment (TPT) 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 99 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 21/08/2023 National Ethics Committee for Research in Humans
Ethics Committee Address
Street address City Postal code Country
Yaounde Yaounde n/a Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of people with clinical risk factors of TB attending health facilities who have a bacteriologically confirmed TB result and are treated for TB 1 month after TB testing
Secondary Outcome Reach, effectiveness, adoption, implementation, and maintenance of these programmatic approaches for TB detection End point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Regional diagnostic and treatment centres Garoua Garoua Cameroon
Regional diagnostic and treatment centres Maroua Maroua Cameroon
Regional diagnostic and treatment centres Douala Douala Cameroon
Regional diagnostic and treatment centres Bamenda Bamenda Cameroon
Regional diagnostic and treatment centres Buea Buea Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Stop TB Partnership Chemin du Pommier 40 Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CHPR Roundabout Bamenda Cameroon Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Cyrille Mbuli cyrillembuli@gmail.com +237674105758 Roundabout
City Postal code Country Position/Affiliation
Bamenda Cameroon CHPR
Role Name Email Phone Street address
Principal Investigator Melissa Sander melissa.sander@gmail.com +237694721484 Roundabout
City Postal code Country Position/Affiliation
Bamenda Cameroon CHPR
Role Name Email Phone Street address
Public Enquiries Cyrille Mbuli cyrillembuli@gmail.com +237674105758 Roundabout
City Postal code Country Position/Affiliation
Bamenda Cameroon CHPR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification Study Protocol 6 months from end of intervention Anyone who wishes access, for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information