SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and... | NCT07714707

NCT07714707

Overview

NCT ID: NCT07714707
Lead Sponsor: KNCV Tuberculosis FoundationOTHER
Official Title: 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
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:

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.

To determine how feasible and acceptable it is for CHWs to perform home-based SIILTIBCY testing, both with and without AI assistance.

To assess the added value, feasibility, and acceptability of using a mobile cough screening application, administered by CHWs, to help rule out TB disease.

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.

The study will be conducted in primary health care facilities in Tajikistan and Tanzania, which have access to short-course TPT regimens. The study population is composed of persons in close contact with people diagnosed with bacteriologically confirmed TB disease, and eligible for TPT as per national guidelines.

The main outcomes of interest are:

SIILTIBCY inter-reader agreement CHW (home-based) and HCW (facility-based)

SIILTIBCY inter-reader agreement CHW with AI reading and without AI reading

Proportion tested for TBI out of those eligible for TBI testing

Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery

Diagnostic agreement between a cough application and symptom screening

Proportion initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing

Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing.

Interest-holders' perspectives on home-based TBI testing and cough app screening.

Budgetary impact scaling-up home-based TBI testing and cough app screening

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Jun 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

• 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:

Having any condition making someone cannot cough voluntarily:

Having aphasia Having a medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat / maxillofacial surgery, vocal cord trauma or nodules Having patent tracheostomy stoma

Within the past year, had:

acute traumatic injury to the head, neck, throat, chest, abdomen, or trunk Chest/abdomen / trunk trauma or surgery, Intracranial surgery Neurovascular injury Neurovascular surgery

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 880Estimated
Primary Purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Christiaan Mulder, MsC PhDContact
christiaan.mulder@kncvtbc.org+31704167234

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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