SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania

NCT07714707 | Not Yet Recruiting

• 1 other identifier: 2025-I4242220-0025484
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered by community health workers (CHWs) with or without AI-facilitated diagnostic tools. The overall goal of this study is to improve access to innovative tuberculosis (TB) preventive services among children and their families in Tanzania and Tajikistan, both settings with a high burden of TB. Persons in close contact with people diagnosed with bacteriologically confirmed TB disease will be identified through the index patient and home visits. They will decide the preferred location for TBI testing, either at home or at the facility. Community health workers will be trained to implement home-based TB prevention services, including TBI testing and AI-assisted reading, and ruling out TB disease using a cough app (along traditional screening practices). The main objectives of the study are:

1. 1.To assess whether CHWs can reliably measure SIILTIBCY results in TB contact persons at their homes, with or without the support of AI-assisted reading tools.
2. 2.To determine how feasible and acceptable it is for CHWs to perform home-based SIILTIBCY testing, both with and without AI assistance.
3. 3.To assess the added value, feasibility, and acceptability of using a mobile cough screening application, administered by CHWs, to help rule out TB disease.
4. 4.To evaluate the impact of these home-based TBI testing strategies on improving uptake and completion of TB preventive treatment (TPT), as well as their budget implications for both the health care system and affected households.
5. 5.SIILTIBCY inter-reader agreement CHW (home-based) and HCW (facility-based)
6. 6.SIILTIBCY inter-reader agreement CHW with AI reading and without AI reading
7. 7.Proportion tested for TBI out of those eligible for TBI testing
8. 8.Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery
9. 9.Diagnostic agreement between a cough application and symptom screening
10. 10.Proportion initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing
11. 11.Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing.
12. 12.Interest-holders' perspectives on home-based TBI testing and cough app screening.
13. 13.Budgetary impact scaling-up home-based TBI testing and cough app screening

Conditions

Tuberculosis Infection, Latent; Tuberculosis Active; TPT

Keywords

AI tools; Contact investigation; Tuberculosis Preventive Treatment; Tanzania; kyrgyzstan; community health care; AI (Artificial Intelligence); Cough screening App; SIILTIBCY

Outcome Measures

Primary Outcomes (2)

• SIILTIBCY inter-reader agreement CHW and HCW

  Inter-reader agreement defined as the proportion of SIILTIBCY assessments with concordant binary interpretations (TBI positive or TBI negative) between a community health worker (home-based interpretation) and a healthcare worker (facility-based interpretation). The numerator is the number of SIILTIBCY assessments with concordant interpretations between CHW and HCW. The denominator is the total number of SIILTIBCY assessments independently interpreted by both a CHW and an HCW.

  From enrollment through 6 months

• SIILTIBCY inter-reader agreement CHW with and without TB connect app (Siiltibcy test reading powered AI tool)

  Inter-reader agreement defined as the proportion of SIILTIBCY assessments with concordant binary interpretations (TBI positive or TBI negative) between a community health worker (CHW) interpreting the test with the Smartpatch and TB Connect app and a CHW interpreting the test without the Smartpatch and TB Connect app. The numerator is the number of SIILTIBCY assessments for which the two CHW interpretations are concordant. The denominator is the total number of SIILTIBCY assessments independently interpreted by both a CHW using the TB Connect app and a CHW not using the app.

  Six months after enrollment for an average of 1 year

Other Outcomes (7)

• Proportion of participants initiating TPT

  Baseline through study completion, an average of 1.5 year

• Proportion of participants with concordant screening results using cough screening application, symptom screening, and chest X-ray (if available)

  From month 2 till through study completion, for an average of 1.5 year

• Proportion of participants completing TPT

  Baseline through study completion, for an average of 1.5 year

Study Arms (2)

SIILTIBCY Testing read by CHW and HCW

EXPERIMENTAL

During the first 6 months of the intervention all eligible participants will be tested for TBI with SIILTIBCY testing and results will be read by a community health care worker and a health care worker

Device: Audiblehealth DX

SIILTIBCY Testing read by an AI assited tool and a health practitioner

EXPERIMENTAL

After the first six months, eligible participants will receive the SIILTIBCY testing that will be read by a health pracitioner and by the AI asstited tool for comparison

Device: CY-TB Patch; Device: Audiblehealth DX

Interventions

CY-TB Patch DEVICE

The TB Smart Patch (CY-TB Patch) is an adhesive patch that is to be placed on the forearm of the test subject by health practitioner. A QR code which is unique to each patch can be seen printed on the patch. Also, a circular flap which is demarcated by dotted line can be seen on the patch. This circular portion is removable and acts as the site for administration of test. The TB Connect app (CY-TB Software) is used to register and monitor the subjects. The app has an integrated system for recording data and tracking each individual. It is to be used by the health practitioners providing SIILTIBCY.

Also known as: CY-TB Software

SIILTIBCY Testing read by an AI assited tool and a health practitioner

Audiblehealth DX DEVICE

The AudibleHealth AI screening platform (RAIsonance Inc) uses advanced AI models to identify individuals who are likely to have active infections with respiratory diseases including TB. These cough sounds, sometimes referred to as Forced Cough Vocalizations (FCVs), provide the basis for respiratory screening assessments using the AI models. All participants will be screened for active TB with this app, and symptom screening rule out prior to being screened for TBI.

SIILTIBCY Testing read by CHW and HCW; SIILTIBCY Testing read by an AI assited tool and a health practitioner

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Contact persons (household and close contacts as defined by country guidelines) of people newly diagnosed with bacteriologically confirmed pulmonary TB disease (or as defined per national guidelines). National guidelines will determine whether we could include both contacts of index patients with drug-susceptible TB and drug-resistant TB.
• Age ≥5 years
• Able to provide written informed consent or assent.

You may not qualify if:

• Confirmed TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for TB disease)
• Likely to move outside the study area during the study period
• People already on TPT at time of recruitment
• Contra-indication for TPT:
• Known sensitivity or intolerance to isoniazid or rifamycins
• Suspected acute hepatitis or known chronic or unstable liver disease
• Alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN)
• Total bilirubin \> 2.5 times the ULN
• On contra-indicated medications (as per national guidelines)
• Contra-indication for SIILTIBCY:
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of SIILTIBCY Product Information.
• Hypersensitivity to Lactococcus lactis.
• Severe local or systemic reaction to other Mycobacterium tuberculosis derived products
• Any vaccination within the last 4 weeks
• Contra-indication for AudibleHealth:

Sponsors & Collaborators

• KNCV Tuberculosis Foundation: lead
• KNCV Tajikistan: collaborator
• KNCV Tanzania: collaborator
• National Tuberculosis and Leprosy Program Tanzania: collaborator
• National Tuberculosis Program, Tajikistan: collaborator

Study Sites (2)

KNCV Tajikistan

Dushanbe, Tajikistan

Location

KNCV Tanzania

Dar es Salaam, Dar es Salaam Region, Tanzania

Location

Related Links

• KNCV website, SCAF-TB page describing the project

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

Christiaan Mulder, MsC PhD

CONTACT

+31704167234; christiaan.mulder@kncvtbc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: July 20, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

TA (1)