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CompletedNCT05581212CaPThaiUpdated Apr 29, 2026

TB Case-Finding, Treatment and Prevention Intervention in Thailand

An interventional study of Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack in Tuberculosis, sponsored by Institut de Recherche pour le Developpement. Completed at 20 sites in Thailand. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Institut de Recherche pour le Developpement · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
7,455
Allocation
Randomized
Sex
All
01

Study summary

The project aimed to test a strategy for the early detection and prevention of tuberculosis in household contacts of tuberculosis patients in order to reduce the morbidity, mortality and transmission of this disease in Thailand. This strategy will be evaluated in comparison with the current programmatic approach through a pragmatic trial with cluster randomization (cluster randomized controlled trial) which will be conducted over the next 3 years. This project is carried out in collaboration with the Tuberculosis Division of the Ministry of Public Health of Thailand, the TB/HIV Research Foundation in Thailand and the London School of Hygiene and Tropical Medicine in England.

Read the detailed description

Title: Implementation of a new Strategic TB Case-Finding, Treatment and Prevention Public Health Pack in Thailand (CapThai) Phase: IV, cluster randomized trial

Population:

adults (>= 18 years old) with pulmonary TB and their household contacts. Sites: 20 clusters (provincial hospitals) in Thailand

Duration of the study:

36 months

Subject participation duration:

9 months

Description of the intervention:

Combined active case-finding, treatment and prevention of TB amongst household contacts of TB cases, associated with initiation of SOC treatment in active TB cases and initiation of TB preventive therapy in those contacts without active TB, based on free screening. This intervention will be compared to the standard of care available in the country.

Overall objective:

To evaluate whether a public health intervention package focusing on the households of newly detected TB cases can increase active case-finding and uptake of TB preventive therapy in Thailand.

Specific objectives:

  1. to compare the initiation and completion of TPT regimens amongst household contacts of infectious TB patients, overall and by gender and age group;
  2. to evaluate the safety of short TPT regimens amongst HH contacts, overall and by gender and age group;
  3. to compare the detection of TB and treatment uptake for active TB amongst HH contacts of infectious TB patients, overall and by gender and age group;
  4. to assess the feasibility of the combined intervention among health care providers and beneficiaries, by gender and age group;
  5. to assess the acceptability of the combined intervention among health care providers and beneficiaries, by gender and age group;
  6. to evaluate the epidemiological impact of the combined intervention.

Study design:

The study uses a Stepped-Wedge Cluster Randomised Trial design. Randomisation will take place at the hospital level (cluster: provincial hospitals with >150 new TB cases/year). Twenty clusters will be enrolled and switch from the control to the intervention phase in four sequences every 3 months in a random order until all clusters are exposed to the intervention.

  1. Intervention Phase: Newly detected bacteriologically confirmed TB patients (≥ 18 years) will be sensitized on the importance of HH contact investigation and TB stigma reduction. They will be asked to enumerate all contacts (name/age/sex/relationship) living in their HH for>1 month at the date of TB diagnostic. Screening invitation cards will be provided for each HH contact (or caregiver for children \<13 years old), inviting them to attend the TB clinic at the selected hospital for free screening and evaluation. Transportation fees will be provided. Contacts detected with active TB will receive recommended treatment. In contacts for whom active TB is formally excluded, TPT will be initiated with the new short regimens: (i) children \<2 years: isonicotine hydrazine (INH)+rifampicin daily for 3 months; (ii) children 2-12 years: INH+rifapentine weekly for 3 months; (iii) children≥13 and adults: INH+rifapentine daily for 1 month.
  2. Control phase: current strategy relying on passive case detection and advice provided to TB patients to refer HH contacts to the TB clinic for screening. The index TB patient will be asked to enumerate HH contacts as above and inform them on the need to be screened at the TB clinic.

Endpoints:

Primary endpoint: Proportion of HH contacts with active TB excluded who are initiated on TPT within 4 weeks of the index TB patient diagnosis - overall, by age group (\<15, ≥15 years) and gender.

Secondary endpoints:

  1. Proportion of participants initiated on TPT who completed TPT;
  2. Proportion of participants in the Intervention phase who were initiated on TPT for whom treatment is discontinued due to intolerance, adverse events, or severe adverse events;
  3. Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 8 weeks of the index TB case diagnosis - overall, by age group (\<15, ≥15 years) and gender;
  4. Proportion of household contacts diagnosed with TB who completed TB treatment in the intervention vs. control phase;
  5. Proportion of contacts receiving TPT who developed TB over the 9 months follow-up period in the intervention vs. control phase.

Estimated time to complete enrollment:

12-15 months

02

Conditions studied

  • Tuberculosis

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Keywords

  • Case-finding
  • Preventive treatment
  • Public Health Pack
  • Household contacts
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 7,455 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

Inclusion of the index cases

  • Age ≥18 years
  • Newly bacteriologically confirmed TB case (within 1 month of diagnosis)
  • Living in the same household for the last 3 months
  • Reporting at least one HH contact
  • Providing written for participation in the study

Inclusion of contacts

  • All contacts living in the same HH, defined as any person who shared the same enclosed living space as the index TB case for one or more nights or for frequent or extended daytime periods for at least one month before the TB diagnosis is made.
  • Providing written informed consent (signed by adult (≥18 years) contacts; or by parents/guardians for minors \< 13 years or incapacitated people; written assent for children ≥13 years and \< 18 years).

Exclusion Criteria:

Exclusion of index cases

  • Index case who do not live in the catchment area of the study cluster
  • Index cases diagnosed with rifampicin resistance, multidrug resistance (MDR) or extensively drug-resistant (XDR-TB)
  • Index cases who are incarcerated

Exclusion of the contacts

- contact currently on TPT or on TB treatment or who finished such treatment in the last 3 months.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
7,455 participants (actual)

Study arms

  • No intervention
    Standard of Care (Control phase)

    In the current standard of care in Thailand, at time of diagnosis and tuberculosis (TB) treatment initiation, TB patients are being advised to tell their household (HH) contacts to consult at the TB clinic for screening and provision of either curative or preventive treatment - according to the screening outcome.

  • Experimental
    Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack (Intervention phase)

    In the selected provinces, individuals (≥18 years) with newly detected bacteriologically confirmed pulmonary Tuberculosis (index TB case) will be sensitized on the importance of HH contact investigation for detection and prevention of TB and stigma reduction. Index TB cases will be asked to enumerate all persons living in their HH for ≥1 month at the date of TB diagnostic (contact list), and provide their name/age/sex and relationship with the index case. Screening will be offered to each HH contact, using screening invitation cards that will be provided to the index TB case, to be handed over to each HH contact (or caregiver for children \<13 years old). Urban and Village Health Volunteers (U/VHV),will visit the HH to enhance awareness of the importance of screening for TB case-finding and prevention and facilitate liaison with the hospital. If active tuberculosis has been formally excluded, they will be eligible to receive the Tuberculosis Preventive Treatment (TPT).

    Other: Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack

Interventions

  • OtherTuberculosis Case-Finding, Treatment and Prevention Public Health Pack

    Combined active case-finding, treatment and prevention of TB amongst HH contacts of TB cases, associated with initiation of standard of care (SOC) treatment in active TB cases and initiation of TB preventive therapy in those contacts without active TB, based on free screening. This intervention will be compared to the standard of care available in the country.

06

What researchers measure

Primary outcomes

  1. Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall

    Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall

    Time frame: Month18

  2. Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (<15, ≥15 years)

    Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (\<15, ≥15 years)

    Time frame: Month18

  3. Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender

    Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender

    Time frame: Month18

Secondary outcomes

  1. Proportion of participants initiated on TPT who completed TPT

    Proportion of participants initiated on TPT who completed TPT

    Time frame: Month 18

  2. Proportion of participants who initiate TPT for whom treatment is discontinued due to adverse events or intolerance in the Intervention phase

    Proportion of participants who initiate TPT for whom treatment is discontinued due to adverse events or intolerance in the Intervention phase

    Time frame: Month 18

  3. Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - overall

    Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - overall

    Time frame: Month 18

  4. Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by age group (<15, ≥15 years)

    Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by age group (\<15, ≥15 years)

    Time frame: Month 18

  5. Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by gender

    Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by gender

    Time frame: Month 18

07

Study locations

20 sites
  • Bang Lamung H.
    Bang Lamung, Thailand
  • Nakornping H.
    Chiang Mai, Thailand
  • Chiangrai Prachanukroh H.
    Chiang Rai, Thailand
  • Chon Buri H.
    Chon Buri, Thailand
  • Kalasin H.
    Kalasin, Thailand
  • Khon Kaen H.
    Khon Kaen, Thailand
  • Lampang H.
    Lampang, Thailand
  • Samut Prakan H.
    Mueang Samut Prakan, Thailand
  • Buriram H.
    Nakhon Ratchasima, Thailand
  • Surin H.
    Nakhon Ratchasima, Thailand
  • Maharaj Nakhon Si Thammarat H.
    Nakhon Si Thammarat, Thailand
  • Phra Nakhon Si Ayutthaya H.
    Phra Nakhon Si Ayutthaya, Thailand
  • Ratchaburi H.
    Ratchaburi, Thailand
  • Samut Sakhon H.
    Samut Sakhon, Thailand
  • Si Sa Ket H.
    Si Sa Ket, Thailand
  • Hat Yai H.
    Songkhla, Thailand
  • Songkhla H.
    Songkhla, Thailand
  • Surat Thani H.
    Surat Thani, Thailand
  • Trang H.
    Trang, Thailand
  • Sunpasitthiprasong H.
    Ubon Ratchathani, Thailand
08

References and documents

Publications

  • Tovar Sanchez T, Ngamvithayapong-Yanai J, Grint D, Beneteau S, Luangjna S, Ouedraogo S, Lachenal N, Bonnet M, Fielding K, Kamolwat P, Lienhardt C. Evaluation of a combined tuberculosis case-finding, treatment and prevention strategy in Thailand: protocol for a pragmatic phase IV stepped-wedge cluster-randomised trial, the CaPThai study. Trials. 2026 Feb 16;27(1):225. doi: 10.1186/s13063-026-09532-7. PubMed 41699679 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Jan 2026, 19 months.

Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 19 months is below that.

Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2022
First posted
Oct 14, 2022
StartActual
May 7, 2024
Primary completionActual
Jan 6, 2026
CompletionActual
Jan 7, 2026
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05581212
Lead sponsor
Institut de Recherche pour le Developpement
Collaborators
Ministry of Health, Thailand, Tuberculosis and HIV Research Foundation, London School of Hygiene and Tropical Medicine
Responsible party
Sponsor
First posted
Oct 14, 2022
Start date
May 7, 2024
Primary completion
Jan 6, 2026
Completion
Jan 7, 2026
Last update
Apr 29, 2026

Study contacts

Christian Lienhardt
study director · Institut de Recherche pour le Developpement

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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