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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

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/092079
Enrollment
12816
Registered
2025-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15- Respiratory tuberculosis

Interventions

Intervention1: A community-based household contact management (CbHCM) model: To improve TPT initiation and completion among household contacts of Persons with TB (PwTB), focused on under-5 (U5) childr

Sponsors

William J. Clinton Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Outcome Name: Proportion of eligible U5 HHCs of PwTB who initiate TPTTimepoint: 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).

Secondary

MeasureTime frame
Outcome Name: Proportion of eligible U5 HHCs of PwTB who complete TPTTimepoint: 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 initiationTimepoint: 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 tracingTimepoint: 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 tracingTimepoint: 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 PwTBTimepoint: 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 HHCsTimepoint: 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 staffTimepoint: Time-point: Assessed at baseline (before implementation begins) and endline (approximately 18 months after the implementation begins)

Countries

India

Contacts

Public ContactDr. Ashwani Khanna

William J. Clinton Foundation

akhanna.ic@wjcf.in8745011280

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026