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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607745884831 Date of Registration: 27/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the performance of the near point of care testing combined with device assistance for sputum collection to detect tuberculosis in people with presumptive TB
Official scientific title Evaluation of the performance of the near point of care PlusLife MiniDock MTB assay combined with Lung Flute ECO for sputum collection to detect tuberculosis in people with presumptive TB
Brief summary describing the background and objectives of the trial New near point of care nucleic acid amplification tests (NPOC-NAAT) to detect tuberculosis (TB) have recently been recommended by the World Health Organization. These NPOC tests are highly portable and much lower cost than existing molecular TB diagnostics. However, the sensitivity of these tests is lower than for existing molecular TB diagnostics, especially among people with paucibacillary tuberculosis. Disposable, inexpensive devices can be used to assist in sputum collection. Device assistance has been shown to help people to produce more sputum for TB testing and to increase the number of people with TB detected in sputum. In this add-on evaluation to an ongoing intervention to improve TB case finding, sites that do not currently have molecular testing will be provided with onsite NPOC molecular testing for TB. Half of the sites will also be provided with disposable devices to aid people with sputum collection, and the performance of the near point of care testing will be evaluated with and without sputum collection assistance. This will be conducted as a highly pragmatic evaluation, providing information about implementation of near point of care testing and use of device assistance for sputum production under near usual care conditions. Developing a better understanding of the performance of each approach under programmatic conditions in different populations at risk of TB is expected to be of use to inform policy decisions. The primary objective of this study is to compare the diagnostic yield of TB with two interventions for TB testing at health facilities: 1) onsite near point of care testing for TB combined with device assistance for sputum production and 2) onsite near point of care testing for TB. Secondary objectives include assessing other patient important outcomes and evaluating the cost and cost-effectiveness of these two interventions.
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 Diagnosis / Prognosis
Anticipated trial start date 15/07/2026
Actual trial start date
Anticipated date of last follow up 31/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 12000
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
Control Group Onsite near point of care testing for TB 1-2 hours (time to collect specimen and perform TB test) People with presumptive TB provide specimens for TB diagnostic testing and the specimens are tested onsite with a near point of care test 6000 Active-Treatment of Control Group
Experimental Group Onsite near point of care testing for TB combined with device assistance for sputum collection 1-2 hours (time to collect specimen and perform TB test) People with presumptive TB provide specimens for TB diagnostic testing and the specimens are tested 6000
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 National TB Program, either onsite or through linkage to a referral diagnostic and treatment center 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. Exclusion criteria for individuals: People currently on TB treatment 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 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 21/05/2026 National Ethical Committee for Research on Human Health
Ethics Committee Address
Street address City Postal code Country
Hygiene Mobile Yaounde Center Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of people with microbiologically confirmed TB among all people eligible for a TB test Date of TB testing
Secondary Outcome To assess additional key patient outcomes of the two interventions 8 months after TB diagnostic evaluation
Secondary Outcome To assess feasibility and acceptability of the two interventions for TB testing End point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Regional health faciliites linked to TB testing and treatment Maroua Maroua Far North Cameroon
Regional health faciliites linked to TB testing and treatment Garoua Garoua North Cameroon
Regional health faciliites linked to TB testing and treatment Ngaoundere Ngaoundere Adamawa Cameroon
Regional health faciliites linked to TB testing and treatment Bertoua Bertoua East Cameroon
Regional health faciliites linked to TB testing and treatment Bamenda Bamenda Northwest Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Stop TB Partnership TB REACH 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 Comfort Vuchas vuchasc@chprhealth.org +237674105758 Roundabout
City Postal code Country Position/Affiliation
Bamenda Cameroon CHPR
Role Name Email Phone Street address
Principal Investigator Melissa Sander msander@chprhealth.org 237694721484 Roundabout
City Postal code Country Position/Affiliation
Bamenda Cameroon CHPR
Role Name Email Phone Street address
Public Enquiries Comfort Vuchas vuchasc@chprhealth.org +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 the article, after de-identification Study Protocol 6 months from end of intervention Anyone who wishes, 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 20/07/2026 Added study objectives New near point of care nucleic acid amplification tests (NPOC-NAAT) to detect tuberculosis (TB) have recently been recommended by the World Health Organization. These NPOC tests are highly portable and much lower cost than existing molecular TB diagnostics. However, the sensitivity of these tests is lower than for existing molecular TB diagnostics, especially among people with paucibacillary tuberculosis. Disposable, inexpensive devices can be used to assist in sputum collection. Device assistance has been shown to help people to produce more sputum for TB testing and to increase the number of people with TB detected in sputum. In this add-on evaluation to an ongoing intervention to improve TB case finding, sites that do not currently have molecular testing will be provided with onsite NPOC molecular testing for TB. Half of the sites will also be provided with disposable devices to aid people with sputum collection, and the performance of the near point of care testing will be evaluated with and without sputum collection assistance. This will be conducted as a highly pragmatic evaluation, providing information about implementation of near point of care testing and use of device assistance for sputum production under near usual care conditions. Developing a better understanding of the performance of each approach under programmatic conditions in different populations at risk of TB is expected to be of use to inform policy decisions in Cameroon and elsewhere. New near point of care nucleic acid amplification tests (NPOC-NAAT) to detect tuberculosis (TB) have recently been recommended by the World Health Organization. These NPOC tests are highly portable and much lower cost than existing molecular TB diagnostics. However, the sensitivity of these tests is lower than for existing molecular TB diagnostics, especially among people with paucibacillary tuberculosis. Disposable, inexpensive devices can be used to assist in sputum collection. Device assistance has been shown to help people to produce more sputum for TB testing and to increase the number of people with TB detected in sputum. In this add-on evaluation to an ongoing intervention to improve TB case finding, sites that do not currently have molecular testing will be provided with onsite NPOC molecular testing for TB. Half of the sites will also be provided with disposable devices to aid people with sputum collection, and the performance of the near point of care testing will be evaluated with and without sputum collection assistance. This will be conducted as a highly pragmatic evaluation, providing information about implementation of near point of care testing and use of device assistance for sputum production under near usual care conditions. Developing a better understanding of the performance of each approach under programmatic conditions in different populations at risk of TB is expected to be of use to inform policy decisions. The primary objective of this study is to compare the diagnostic yield of TB with two interventions for TB testing at health facilities: 1) onsite near point of care testing for TB combined with device assistance for sputum production and 2) onsite near point of care testing for TB. Secondary objectives include assessing other patient important outcomes and evaluating the cost and cost-effectiveness of these two interventions.