Actively Recruiting

Phase Not Applicable
All Genders
NCT06971952

Tuberculosis in Rural and Malnourished Populations

Led by University of Virginia · Updated on 2026-05-05

360

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

B

Burroughs Wellcome

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: Tuberculosis (TB) remains a large public health threat in Tanzania with an estimated incidence of 195 per 100,000 people in 2022 and 36% of cases going undiagnosed. Nutritional and financial barriers combine to compound the burden of TB in Tanzania and many other high burden countries. Objectives: In this study, we aim to evaluate the effect and cost-effectiveness of conditional cash transfer added to the current facility-based approach to improve TB screening among household contacts (HHCs) of index people diagnosed with TB disease (PWTB) in rural Tanzania; and characterize the prevalence of undernutrition among HHCs of index PWTB and quantify the effect of undernutrition severity on the progression to active TB disease. Methods: In this prospective, interventional cohort study we plan to enroll 360 PWTB and their households within 2 months of TB treatment initiation. The duration of the study is 3 years in total: 2-year enrollment period, divided equally between the current standard of care phase and the added conditional cash transfer phase. All participating households will be visited 2 months after enrollment to complete TB screening for all HHCs and perform anthropometric measurements, and then followed a 2-year period to evaluate for incident TB disease among HHCs. Data analysis: The proportion of households completing TB screening procedures for all HHCs during phase 1 will be compared to that during phase 2 using a chi-square test to evaluate the effect of conditional cash transfer on completion of HHC TB screening. A similar approach will be used to compare proportions of HHCs diagnosed with active TB disease based on nutritional status. We will use regression and Bayesian modeling to quantify the effect of demographic, nutritional and socioeconomic predictors on completion of HHC TB screening and the incidence of TB disease among HHCs to prioritize higher risk subgroup for TB prevention effort. Impact: Successful completion of this proposal will informTB programs in many high burden countries with implementable interventions that can be scaled in rural communities to prioritize TB prevention efforts to the HHCs at the highest risk of developing TB disease

CONDITIONS

Official Title

Tuberculosis in Rural and Malnourished Populations

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Index person diagnosed with drug-sensitive pulmonary tuberculosis and starting TB treatment within 2 months of enrollment
  • Index person resides within the catchment area of Haydom Lutheran Hospital
  • Index person intends to receive TB care at a participating study site
  • Index person (or parent/guardian if under 18) and head of household are able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent or assent when applicable
  • Residing or receiving TB care outside the catchment area of study sites
  • Prior completion of TB screening for all household members

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Trial Site Locations

Total: 1 location

1

Haydom Lutheran Hospital

Haydom, Manyara Region, Tanzania

Actively Recruiting

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Research Team

G

Ghassan Ilaiwy, MD MPH

CONTACT

T

Tania A. Thomas, MD MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

2

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