Tuberculosis (TB) Aftermath

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    3228
  • sponsor
    Johns Hopkins University
Updated on 12 May 2022
Accepts healthy volunteers

Summary

TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies that are presently being considered by the RNTCP for detecting recurrent TB and provide evidence needed to implement and scale the preferred intervention.

The proposed study will address this gap, through the following specific aims:

Primary Aim 1: To conduct a non-inferiority randomized trial to measure the comparative effectiveness of two potentially implementable ACF interventions within the RNTCP, conducted by existing RNTCP "home visitors"

Primary Aim 2: To characterize implementation processes of the ACF interventions using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to inform future scale-up and sustainability.

Primary Aim 3: To model the impact and cost effectiveness of the ACF interventions evaluated in the trial, and of potential alternative strategies for the targeting and timing of those interventions.

Secondary Aim: To measure the association of the severity, chronicity and progression of post-TB lung impairment with recurrent TB disease.

Description

India is home to 1/3rd of the world's estimated three million annual undetected TB cases. The primary objective of the investigators' Tuberculosis (TB) Aftermath study is to develop, implement and measure feasible case finding strategies among recently treated TB patients in India, a population known to be at high risk for recurrent disease. In a recent analysis of the TB treatment cascade in Indian public-sector hospitals, of the 1.2 million patients who successfully complete treatment each year, approximately 10% experience TB recurrence within 1 year, giving the patients a TB incidence rate 50 times higher than thae overall population. Thus, active case finding (ACF) approaches targeting recently treated TB cases may be an effective component of a combination strategy to reduce India's TB burden and help detect many of the "missing millions." The Indian National TB Control Program (RNTCP)'s new strategic plan for TB elimination strongly recommends developing and implementing a scalable surveillance system for recurrent TB. The investigators' formative discussions with the RNTCP leadership revealed that a key knowledge gap is insufficient evidence on the yield and cost-effectiveness of ACF strategies among treated TB patients. These discussions also emphasized the RNTCP's strong interest in household (HH) follow-up screening for these patients. The World Health Organization's Systematic Screening for Active TB guidelines suggest that screening for recurrent TB in treated TB patients is a "conditional recommendation"; conditional only because there is a lack of evidence. TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies that are presently being considered by the RNTCP for detecting recurrent TB and provide evidence needed to implement and scale the preferred intervention. While treated TB patients and patients' HH contacts represent a high risk population for recurrent and incident TB, with over 1 million TB cases diagnosed annually in India, it may not be feasible to intensively follow all patients after TB treatment. Thus, lower-cost approaches such as telephone-based outreach could increase the reach of ACF, and targeted implementation may be needed to prioritize resources. Thus, the investigators will determine if visiting every HH of treated TB patients or visiting just those identified as symptomatic through an initial telephonic screening call will identify a similar yield of recurrent TB. The investigators' prior work in India has shown higher risk of recurrent disease among TB patients who smoke, consume alcohol, and those with untreated diabetes or respiratory impairment.

The proposed study will address this gap, through the following specific aims:

Primary Aim 1: To conduct a non-inferiority randomized trial to measure the comparative effectiveness of two potentially implementable ACF interventions within the RNTCP, conducted by existing RNTCP "home visitors": (i) Household ACF (HHACF) by symptom screen and sputum collection among treated TB patients and patients' HH contacts and (ii) ACF by periodic telephonic interviews (TACF) followed by HH screen for HHs reporting any symptomatic members among treated TB patients and patients' HH contacts. The investigators will implement both interventions at 6 and 12 months following treatment completion by the index TB patient, and all HHs will have a final HH ACF visit 18 months post-treatment completion ("mop up") for comparison between arms. For both strategies, the investigators will calculate and compare the number of TB cases (recurrent and new HH cases) detected per index patient in each study Arm.

Primary Aim 2: To characterize implementation processes of the ACF interventions using the RE-AIM framework to inform future scale-up and sustainability. The investigators will use the RE-AIM framework to: (1) understand barriers and facilitators to implementation of the two interventions; (2) identify sub-populations that are best reached by the interventions and sub-populations who may benefit the most from the interventions; and (3) contribute knowledge to improve health services that span from the clinic to the community and home. The investigators will enhance the RE-AIM approach, by exploring the acceptability of the strategies in depth across three key stakeholder groups (TB patients, HH members, and health care personnel) to optimize implementation.

Primary Aim 3: To model the impact and cost effectiveness of the ACF interventions evaluated in the trial, and of potential alternative strategies for the targeting and timing of those interventions: To better inform RNTCP decisions using locally-collected data, the investigators will use data from the trial (on TB incidence and detection, targetable risk heterogeneity, and intervention costs) to model and compare potential strategies for ACF in terms of expected diagnostic yield, cost effectiveness, and impact on TB control in India. A Markov model of the burden of new and recurrent TB at the HH level over time after index case diagnosis will be used to model the lifetime impact of ACF interventions on HH TB morbidity, mortality, and time with infectious TB. The investigators will estimate cost-effectiveness by calculating the incremental cost per Disability Adjusted Life Years (DALY) averted. Estimates of the contributions of recurrent TB and HH transmission to population-wide TB incidence will be used within a population-level transmission model to predict impact on India's TB epidemic.

Secondary Aim: To measure the association of the severity, chronicity and progression of post-TB lung impairment with recurrent TB disease. PTB is associated with lung injury which can persist despite successful therapy. Lung sequelae of treated PTB are increasingly recognized as an independent risk factor for chronic obstructive pulmonary disease (COPD) and, an important contributor of excess morbidity and mortality. Clinically, the extent of lung involvement, including cavitation, on chest X-rays has been shown to correlate with poor response to TB therapy and recurrent disease. We have previously shown that poor respiratory health status, measured by respiratory questionnaires, was associated with recurrent TB disease. The pulmonary TB and lung impairment dynamic may be a vicious cycle; treated TB patients with pulmonary sequelae may be at higher risk of chronic lung diseases and subsequently recurrent TB. Therefore, our secondary objective is to measure the degree of lung impairment in treated TB cases and its association with TB recurrence. The degree of lung impairment in TB cases will be assessed by comparing with apparently healthy controls with no evidence of TB disease.

TB Aftermath will answer key questions in a population that is often ignored by the TB community once treatment is complete, despite being at considerable risk for recurrent TB disease. The investigators will provide evidence for an effective and scalable strategy targeting HHs of treated TB cases, a high priority of the RNTCP. The investigators' high TB burden setting, strong multidisciplinary team, communication with the RNTCP and state TB program, and proven research infrastructure ensures successful implementation of TB Aftermath.

Details
Condition Tuberculosis (TB), Tuberculosis of Lung
Treatment Telephonic Active case finding, House Hold Active Case Finding (HHACF)
Clinical Study IdentifierNCT04333485
SponsorJohns Hopkins University
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Those who are registered at one of the study TB Units (TUs) in Pune district as treatment completed or cured (regardless of type of TB or duration of treatment)
Confirmed treatment completion or cure status by the referring medical officer of the study TU
Date of treatment completion within 60 days of date of enrolment
Ability and willingness of participant or legal guardian/representative to provide informed consent to participate in Arm 1 House Hold Active Case Finding (HHACF) or Arm 2 Active case finding through telephone(TACF) (NOTE: Illiterate participants or participants with cognitive disabilities may be enrolled based on local regulatory policies, with the appropriate provisions for informed consent.)
All household contacts of TB cases who are able and willing to provide informed consent to participate are eligible. HH contacts who are <18 years old are eligible for enrolment if a legal guardian/representative provides informed consent

Exclusion Criteria

Completed anti-TB treatment at a private sector clinic or TU outside of the study (final visit not registered at one of the study TB units)
Actively on anti-TB treatment
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