CTRI

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CTRI Number

CTRI/2025/07/092079 [Registered on: 31/07/2025] Trial Registered Prospectively

Last Modified On:

16/10/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Other (Specify) [Implemntation research of health system delivery Trial]

Study Design

Cluster Randomized Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL
NIL	Other

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ashwani Khanna
Designation	Consultant
Affiliation	William J. Clinton Foundation
Address	Tuberculosis department, 40, Okhla Industrial Estate Phase 3 Rd, Behind Modi Mill, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi South DELHI 110020 India
Phone	8745011280
Fax
Email	akhanna.ic@wjcf.in

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr. Ashwani Khanna
Designation	Principal Investigator
Affiliation	William J. Clinton Foundation
Address	40, Okhla Industrial Estate Phase 3 Rd, Behind Modi Mill, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi South DELHI 110016 India
Phone	8745011280
Fax
Email	akhanna.ic@wjcf.in

Details of Contact Person
Public Query

Name	Dr. Ashwani Khanna
Designation	Consultant
Affiliation	William J. Clinton Foundation
Address	Tuberculosis department, 40, Okhla Industrial Estate Phase 3 Rd, Behind Modi Mill, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi South DELHI 110020 India
Phone	8745011280
Fax
Email	akhanna.ic@wjcf.in

Source of Monetary or Material Support
Modification(s)

Monetary support is provided by the Clinton Health Access Initiative Inc. (CHAI), a nonprofit corporation organized under the laws of the State of Arkansas USA, with its address at 383 Dorchester Avenue Suite 300 Boston MA 02127 USA

Primary Sponsor

Name	William J. Clinton Foundation
Address	40, Okhla Industrial Estate Phase 3 Rd, Behind Modi Mill, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi 110020, Phone: 011-43050000
Type of Sponsor	Other [Not for profit]

Details of Secondary Sponsor
Modification(s)

Name

Address

Countries of Recruitment

India

Sites of Study

No of Sites = 69
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Samsuddin Khan	Agra	Households Agra UTTAR PRADESH	96992 27558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Aligarh	Household Aligarh UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Ambedakar Nagar	Household Ambedaker Nagar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Araria	Households Araria BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Aurangabad	Households Aurangabad BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Ayodhya/Faizabad	Household Faizabad UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Azamgarh	Household Azamgarh UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Badaun	Household Budaun UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Bahraich	Household Bahraich UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Ballia	Household Ballia UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Barabanki	Household Barabanki UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Bareilly	Household Bareilly UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Begusarai	Household Begusarai BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Bhagalpur	Households Bhagalpur BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Bhojpur	Households Bhojpur BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Bijnor	Household Bijnor UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Bulandshahar	Household Bulandshahar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Buxar	Household Buxar BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Chandauli	Household Chandauli UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Darbhanga	Household Darbhanga BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Deoria	Household Deoria UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Etah	Household Etah UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Fatehpur	Household Fatehpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Firozabad	Household Firozabad UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Gautam Buddha Nagar	Household Gautam Buddha Nagar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Gaya	Household Gaya BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Ghaziabad	Household Ghaziabad UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Ghazipur	Household Ghazipur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Gonda	Household Gonda UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	GopalGanj	Household Gopalganj BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Gorakhpur	Household Gorakhpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Jaunpur	Household Jaunpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Jhansi	Household Jhansi UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Kaimur	Household Kaimur (Bhabua) BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Kanpur Nagar	Household Kanpur Nagar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Katihar	Household Katihar BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	kheri	Household Kheri UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Kushinagar	Household Kushinagar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Lalitpur	Household Lalitpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Lucknow	Household Lucknow UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Madhubani	Households Madhubani BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Mathura	Household Mathura UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Meerut	Household Meerut UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Mirzapur	Household Mirzapur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Moradabad	Household Moradabad UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Munger	Household Munger BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Muzaffarpur	Household Muzaffarpur BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Nalanda	Household Nalanda BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Pashchim Champaran	Household Pashchim Champaran BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Patna	Household Patna BIHAR	99555 42056 pdas@wjcf.in
Dr Samsuddin Khan	Pratapgarh	Household Pratapgarh UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Prayagraj/Allahabad	Household Allahabad UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Purba Champaran	Household Purba Champaran BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Purnia	Household Purnia BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Rae Bareily	Household Rae Bareli UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Rampur	Household Rampur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Rohtas	Household Rohtas BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Saharanpur	Household Saharanpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Saharsa	Household Saharsa BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Samastipur	Household Samastipur BIHAR	09955542056 pdas@wjcf.in
Dr Pranati Das	Saran	Household Saran BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Shahjahapur	Household Shahjahanpur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Samsuddin Khan	Siddharthnagar	Household Siddharthnagar UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Sitamarhi	Household Sitamarhi BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Sitapur	Household Sitapur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Siwan	Household Siwan BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Unnao	Household Sitapur UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in
Dr Pranati Das	Vaishali	Household Vaishali BIHAR	09955542056 pdas@wjcf.in
Dr Samsuddin Khan	Varanasi	Household Varanasi UTTAR PRADESH	09699227558 samsuddin.khan@wjcf.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Monk Prayogshala	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: A15\|\|Respiratory tuberculosis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	A community-based household contact management (CbHCM) model	HHC management will be conducted as per routine health systems settings, without the CbHCM model. TA will be provided at the state level for HSS, as in the intervention arm, to support capacity building, improve data management, strengthen drug supply chains, streamline incentive payouts to healthcare workers, and strengthen review and monitoring processes to include TPT indicators. However, since the CbHCM model will not be implemented in control districts, there will be no dedicated district coordinators for model implementation.
Intervention	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) children. This will be led by Accredited Social Health Activists (ASHAs), TB Health Visitors (TB-HVs), and Patient Provider Support Agency (PPSA) staff. The CbHCM model will integrate PwTB household visits, household contacts (HHCs) counseling, streamlined referrals, follow-ups, better access to treatment and drugs in Ayushman Arogya Mandirs (AAMs), and child-friendly formulations of 3HP to close key gaps in facility-based approaches. The PPSA staff will be provided monetary incentives to conduct CbHCM activities for household contacts of PwTB under private care. Technical Assistance (TA) will be provided at the state level for Health Systems Strengthening (HSS)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Centralized

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Outcome Name: Proportion of eligible U5 HHCs of PwTB who initiate TPT	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 Outcome

Outcome	TimePoints
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)

Target Sample Size

Total Sample Size="12816"
Sample Size from India="12816"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="4"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [akhanna.ic@wjcf.in].

For how long will this data be available start date provided 04-04-2030 and end date provided 04-04-2035?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

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.