Implementation research on community-based household contact management to strengthen tuberculosis prevention treatment for under-5 contacts of people with TB in Bihar and Uttar Pradesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12,816
- 试验地点
- 69
- 主要终点
- Outcome Name: Proportion of eligible U5 HHCs of PwTB who initiate TPT
研究概览
简要总结
This implementation research study will implement a community-based Household Contact Management (CbHCM) model to improve TB preventive treatment (TPT) initiation and completion among under-five (U5) household contacts (HHCs) of people with TB (PwTB). The model will strengthen district coordination, decentralise TPT access through Ayushman Arogya Mandirs (AAMs), engage key health personnel (ASHAs, TB-HVs, and PPSA staff), and integrate health systems strengthening (HSS) measures, including technical assistance, data management, and drug supply chain improvements.
The outcome assessment will be done through a pragmatic, cluster-randomized trial. The trial will assess the model’s effect on TPT initiation (primary outcome), TPT completion, contact tracing, TB diagnosis, time allocation among key health personnel, and implementation challenges (secondary outcomes) using baseline, process evaluation, and endline quantitative and qualitative surveys. Findings will inform programmatic decision-making and support the phased transition of the model to the National TB Elimination Program (NTEP) for long-term sustainability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The study population includes all HHCs of Drug Sensitive-Pulmonary TB (DS-PTB) patients as per the Current district Notification Registers on Ni-kshay for the study districts.
- •Inclusion Criteria for the outcome assessment: PwTB: Notified DS-PTB cases (non-DR at diagnosis) in study districts, identified from the Ni-kshay Notification Register, with a diagnosis 30-60 or 120-150 days before enumeration, and who had U5 HHCs within 30 days post-diagnosis.
- •Irrespective of age.
- •U5 HHCs: U5 children who lived with an eligible PwTB in a study district during the 30-day post-diagnosis period, as reported by the PwTB.
- •If there are multiple eligible households, one is randomly selected (weighted by the number of U5 HHCs), and one U5 HHC is randomly selected for the caregiver survey.
- •Key Health Personnel: For each state, we will randomly select the KHP staff stratified by KHP type (TB-HVs and PPSA staff) from a list of TB-HVs and PPSA staff sourced from the State TB Office.
- •We will attempt to include only active personnel, if possible, using admin or program data.
- •The numbers will be equally split between the treatment and control groups.
排除标准
- •Exclusion Criteria for the outcome assessment: PwTB: Deceased, denies TB diagnosis, refuses to speak or consent, has no eligible U5 HHCs, current district/TB unit at treatment initiation or current residence (per phone survey) is outside the study district/block.
- •U5 HHCs: U5 caregivers (or PwTB) who deny consent for participation.
结局指标
主要结局
Outcome Name: Proportion of eligible U5 HHCs of PwTB who initiate TPT
时间窗: The outcome will be assessed during the baseline phase (tentative October 2025), and 18 months after implementation begins during the endline phase (tentative June 2027).
次要结局
- Outcome Name: Proportion of eligible U5 HHCs of PwTB who complete TPT(Time-point: Measured 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Proportion of eligible U5 HHCs of PwTB who complete TPT, conditional on initiation(Time-point: Measured within 30-60 days and 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Proportion of U5 HHCs screened for TB as part of contact tracing(Time-point: Measured within 30-60 days and 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Proportion of U5 HHCs diagnosed with TB as part of contact tracing(Time-point: Measured within 30-60 days and 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Average proportion of HHCs screened per PwTB(Time-point: Measured within 30-60 days and 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Average time between diagnosis of the PwTB and TPT initiation for eligible U5 HHCs(Time-point: Measured within 30-60 days and 120-150 days post-diagnosis of the notified PwTB)
- Outcome Name: Changes in time allocation for TB and non-TB tasks among ASHAs, TB-HVs, and PPSA staff(Time-point: Assessed at baseline (before implementation begins) and endline (approximately 18 months after the implementation begins))
研究者
Dr Ashwani Khanna
William J. Clinton Foundation