Tuberculosis in Rural and Malnourished Populations

Recruiting now · Not applicable

Conditions studied: Tuberculosis (TB), Undernutrition

In brief

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

Key facts

Study ID

NCT06971952

Run by

University of Virginia

People needed

360

Starts

2025-09-01

Expected to finish

2030-09-01

Last updated by the study team

2026-05-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Index person/people diagnosed with drug sensitive pulmonary tuberculosis disease (PWTB) and starting TB treatment within 2 months of enrollment, of any age.
• Index PWTB are eligible if they reside within the catchment area of Haydom Lutheran Hospital (HLH), and
• Index PWTB intend to receive TB care at a participating study site.
• Index PWTB (or their parent or guardian if index PWTB are <18 years) and head of household (if different from index PWTB) are able and willing to provide informed consent.

You may not qualify if…

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

Where it is running

• Haydom Lutheran Hospital — Haydom, Manyara Region, Tanzania (enrolling)

Full record on ClinicalTrials.gov

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