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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 880
- 试验地点
- 2
- 主要终点
- SIILTIBCY inter-reader agreement CHW and HCW
研究概览
简要总结
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
详细描述
Despite renewed global commitments to end TB, as reinforced by the UNHLM on TB, progress remains insufficient to meet TB elimination targets. A critical barrier is the limited reach and uptake of TPT, which continues to rely heavily on facility-based models that are often inaccessible or burdensome for those at risk. A fundamental shift toward broader, community-delivered TPT is urgently needed to close this implementation gap.
One key limitation in current TBI diagnostics, such as the traditional tuberculin skin test (TST), is the requirement for a follow-up visit 48-72 hours after administration to measure the result. This return visit is usually at the clinic, typically performed by a healthcare worker (HCW), which introduces significant challenges including loss to follow-up, logistical burden, and variability in result interpretation. These issues hinder timely initiation of TPT. The SCAF-TB study aims to evaluate a novel, home-based TB infection testing model using the WHO-endorsed SIILTIBCY skin test combined with a skin patch diagnostic paired with an AI-driven smartphone application to enable community-based result interpretation. This approach eliminates the need for clinic visits and may reduce inter-reader variability by leveraging technology for standardized, home-based result reading.
Apart from that, TB screening currently depends largely on chest X-rays, which are not always easily accessible and often require visits to healthcare facilities. New, more portable screening technologies-such as the AudibleHealth AI platform, which uses machine learning to analyze cough sounds and flag potential respiratory infections such as TB-could offer an innovative alternative. This study aims to evaluate the feasibility of this tool in detecting TB patients, providing evidence on whether such digital solutions can support or enhance future TB screening strategies at community level.
Moreover, prior studies have demonstrated that shifting TPT services from healthcare facilities to community-based delivery-particularly through community health workers (CHWs)-is not only feasible but also preferred, highly acceptable to patients, and cost-effective in various settings (32). Building on this evidence, SCAF-TB will assess the effectiveness, acceptability, and scalability of this integrated, decentralized TB prevention algorithm.
Objectives The overall goal of SCAF-TB is to improve access to innovative TB preventive services among children and their families in Tanzania and Tajikistan, both settings with a high burden of TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •• 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
结局指标
主要结局
SIILTIBCY inter-reader agreement CHW and HCW
时间窗: From enrollment through 6 months
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.
SIILTIBCY inter-reader agreement CHW with and without TB connect app (Siiltibcy test reading powered AI tool)
时间窗: Six months after enrollment for an average of 1 year
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.
次要结局
未报告次要终点
研究者
Christiaan Mulder
Principal Investigator
KNCV Tuberculosis Foundation