Tuberculosis and co-existing chronic diseases in West Africa: patterns, causes, and improved diagnosis
| ISRCTN | ISRCTN17649097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17649097 |
| Sponsor | Medical Research Council Unit The Gambia at the LSHTM |
| Funder | European and Developing Countries Clinical Trials Partnership |
- Submission date
- 16/07/2026
- Registration date
- 20/08/2026
- Last edited
- 20/08/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculosis (TB) remains one of the most common serious infections in West Africa. Many people being treated for TB also live with other long-term health conditions at the same time, such as diabetes mellitus, high blood pressure, HIV, or depression, but these are often missed, which can make TB harder to treat and recovery slower. This study aims to find out how often TB occurs alongside other chronic illnesses, who is most affected, and whether newer tools (including artificial intelligence and advanced laboratory testing) can help detect these conditions earlier and improve care.
Who can participate?
People of any age who have just been diagnosed with TB, whether the ordinary (drug-sensitive) form or the harder-to-treat (drug-resistant) form. This includes children, teenagers, and adults.
What does the study involve?
Taking part mainly involves a set of health checks at the start, in addition to a person's normal TB care. These include a chest X-ray reviewed with the help of AI software, tests for TB and drug resistance, a blood test for diabetes, a blood pressure check, and a short questionnaire about mood and wellbeing. Everyone is referred to their nearest TB treatment centre for standard treatment, and anyone found to have another condition is also referred to the appropriate clinic. Participants receive two follow-up phone calls, at around 2 months and 6 months, to check on their treatment and wellbeing. Some participants, healthcare workers, and policymakers in The Gambia and Nigeria are also invited to take part in interviews or group discussions about living with these conditions and the care available.
What are the possible benefits and risks of participating?
Participants benefit from being checked for other health conditions that might otherwise go undetected, and from being referred for treatment if anything is found. The risks are small: the main ones are minor discomfort from a blood test, the time taken to answer questions or attend an interview, and the possibility that some questions (for example about mood) touch on sensitive topics. This is an observational study, so no new or experimental treatment is being tested.
Where is the study run from?
The study is coordinated by the Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine (MRCG at LSHTM). It is carried out at eight partner institutions across seven West African countries, including Senegal, The Gambia, Guinea-Bissau, Mali, Burkina Faso, Ghana, and Nigeria.
When is the study starting and how long is it expected to run for?
November 2026 to June 2031
Who is funding the study?
The study is funded by the Global Health EDCTP3 Joint Undertaking
Who is the main contact?
1. Prof. Toyin Togun, Toyin.Togun@lshtm.ac.uk
2. Mr Dembo Kanteh, Dembo.Kanteh@lshtm.ac.uk
Contact information
Principal investigator, Scientific
Medical Research Council Unit The Gambia at the LSHTM (MRCG at LSHTM)
Banjul
0000
Gambia
 ORCID ID |
0000-0002-8477-4462 |
|---|---|
| Phone | +220 772 1204 |
| Toyin.Togun@lshtm.ac.uk |
Public
Medical Research Council Unit The Gambia at the LSHTM (MRCG at LSHTM)
Banjul
00000
Gambia
| Phone | +220 (0)992 3545 |
|---|---|
| Dembo.Kanteh@lshtm.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cross sectional study |
| Scientific title | WANETAM-4 TB Work Programme: Clinical and Molecular Epidemiology of TB Multimorbidity in West Africa |
| Study objectives | 1. Determine the prevalence, pattern, and determinants of TB multimorbidity across the life course in West African populations 2. Apply artificial intelligence (AI)-based approaches to enhance diagnosis of TB multimorbidity across the life course 3. Assess the quality of life of individuals with TB multimorbidity, as well as health system capacity and integration and pathways to relevant care within national health systems 4. Determine the influence of multimorbidity on the emergence, evolution, and fixation of drug resistance-associated mutations by microbiology and genomic epidemiology. 5. Define the genetic and strain-related factors that predispose to and/or increase the risk of multimorbidity in drug-sensitive and drug-resistant TB patients. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Methodology | 1. To determine the prevalence, patterns, distributions and risk factors of TB multimorbidity across the life course in West African populations Multicountry cross-sectional study on TB multimorbidity to be conducted at eight WAPIs located in seven TB-endemic West African countries with high TB incidence (i.e., TB incidence rate >40 cases per 100,000 population per year), including Senegal, The Gambia, Guinea-Bissau, Mali, Burkina Faso, Ghana, and Nigeria. Consecutive recruitment of all newly-diagnosed persons with either drug-sensitive or drug-resistant TB aged <15, 15–49, and >50 years over a 24-month period. We will use conventional diagnostic tools (e.g., Xpert Ultra and mycobacterial culture for TB, HbA1c for diabetes, blood pressure monitoring) and validated mental health screening scales (e.g., PHQ-9) for depression. Participants will be referred to the DOTS TB treatment centre nearest their home address for the standard TB treatment according to the respective national TB treatment guideline. Participants with TB multimorbidity will also be referred to the medical outpatient department and/or HIV clinics nearest their home address for treatment and follow-up of the co-morbid condition. Telephone follow-up will be conducted after 2 and 6 months to ascertain well-being and treatment and survival status. 2. To apply artificial intelligence (AI)-based approaches to enhance diagnosis of TB multimorbidity across the life course This mathematical modelling sub-study that includes application of AI-based approaches will be embedded within the multicountry cross-sectional study on TB multimorbidity (Task 1.1). Evaluate the performance of the optimised AI-based qXR/qTrack computer-aided detection (CAD) for TB device (Qure.ai) for the diagnosis of TB and comorbidities within the national public health systems in West Africa. Use mathematical modelling with multimodal AI-driven tools to develop predictive models for TB-NCD risk to enhance diagnosis and prioritise high-risk patients. 3. To assess the quality of life of individuals with TB multimorbidity, as well as health system capacity and integration and pathways to relevant care within national health systems This qualitative sub-study on quality of life, socioeconomic and cultural barriers, and health system capacity to address TB multimorbidity will also be embedded within the multicountry cross-sectional study on TB multimorbidity, specifically at the study sites in The Gambia and Nigeria. We will conduct in-depth semi-structured narrative interviews (n = 24) and focus group discussions (FDGs) with separate groups of (i) persons with TB multimorbidity, (ii) healthcare workers, and (iii) policymakers at each study site (8 – 10 persons per FGD). We will use a standardized framework (e.g., WHO Health Systems Building Blocks) to assess infrastructure, workforce training, diagnostic capacity (e.g., availability of Xpert MTB/RIF or glucose testing), and funding. 4. To determine the influence of multimorbidity on the emergence, evolution and fixation of drug resistance-associated mutations by microbiology and genomic epidemiology This is a genomic study of DR-TB multimorbidity with next-generation whole genome sequencing (WGS) of MTBC isolated from multimorbid individuals with confirmed drug-sensitive and drug-resistant TB. Apply paired culture-free and culture-based whole genome sequencing assays by the Illumina platform for improved diagnosis of MDR-TB and resistant strain catalogue Investigate the types and prevalence of drug resistance and pattern/diversity of drug-resistant strains Direct gene expression analysis (mycobacterial load assay) to determine bacterial load at different time points during clinical follow-up. 5. To define the genetic and strain-related factors that predispose to and/or increase the risk of multimorbidity in drug-sensitive and drug-resistant TB patients Pair next-generation sequencing/molecular microbiology data with clinical data on comorbidities in multimorbid drug-sensitive and drug-resistant TB patients to understand the underlying biological, genomic and molecular pathways toward TB multimorbidity. Use bioinformatics approaches to explore the DR-TB/comorbidity synergies (e.g., diabetes worsening DR-TB prognosis). Investigate associations between the diverse MTBC lineages in West Africa and TB multimorbidity; the region has seven out of the nine classified phylogenetic lineages, including Mycobacterium africanum, which is geographically restricted to West Africa. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Diagnostic performance of a WHO-compliant AI-assisted computer-aided detection tool for TB and comorbidities, measured against Xpert MTB/RIF Ultra and mycobacterial culture as the reference standard at baseline |
| Completion date | 30/06/2031 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | All |
| Lower age limit | 0 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 1230 |
| Key inclusion criteria | 1. Newly-diagnosed TB patients 2. Drug-sensitive or drug-resistant TB 3. Children, adolescents, and adults (aged <15, 15–49, and >50 years) |
| Key exclusion criteria | 1. TB patient unable or unwilling to give informed consent 2. TB patients with altered sensorium |
| Date of first enrolment | 01/11/2026 |
| Date of final enrolment | 31/10/2028 |
Locations
Countries of recruitment
- Burkina Faso
- Gambia
- Ghana
- Guinea-Bissau
- Mali
- Nigeria
- Senegal
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Principal Investigator (Prof. Toyin Togun) |
Editorial Notes
16/07/2026: Study's existence confirmed by the European and Developing Countries Clinical Trials Partnership.
