Implementation of a New Strategic TB Case-Finding, Treatment and Prevention Public Health Pack in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,455
- 试验地点
- 20
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 informed consent 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).
排除标准
- •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.
研究组 & 干预措施
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.
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).
干预措施: Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack (Other)
结局指标
主要结局
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)
时间窗: Month18
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 - overall
时间窗: Month18
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 - by gender
时间窗: Month18
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
次要结局
- Proportion of participants who initiate TPT for whom treatment is discontinued due to adverse events or intolerance in the Intervention phase(Month 18)
- 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)(Month 18)
- Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by gender(Month 18)
- Proportion of participants initiated on TPT who completed TPT(Month 18)
- Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - overall(Month 18)