Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haydom Lutheran Hospital
Haydom, Manyara Region, Tanzania
Actively Recruiting
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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