Clinical trial NCT06971952: Tuberculosis in Rural and Malnourished Populations
Official title: Closing the Tuberculosis Diagnosis Gap in Rural and Malnourished Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tuberculosis (TB)
Undernutrition
Keywords: Tuberculosis
Active case finding
Undernutrition
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Burroughs Wellcome
name: The American Society of Tropical Medicine and Hygiene
First posted: 2025-05-14
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: TB screening completion for all HHCs before the study-initiated home visit
timeFrame: From enrollment to the time of home visit at 2 months
measure: Quantify the effect of undernutrition severity on the progression to active TB disease
timeFrame: one year
Secondary outcomes:
measure: The cost-effectiveness of conditional cash transfer added to the current facility-based approach to improve TB screening among HHCs of index PWTB
timeFrame: 20-year time horizon for the cost-effectiveness model
Other outcomes:
Locations:
city: Haydom
country: Tanzania
facility: Haydom Lutheran Hospital
state: Manyara
Study officials:
affiliation: University of Virginia
name: Tania Thomas, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: