Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2025-06-01
2030-09-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SCREENING
NONE
Study Groups
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Facility-based Household Contact Screening
a studied, 12-month lead-in period to prospectively measure facility-based household tuberculosis (TB) screening activities in collaboration with TB Clinic Staff at Haydom Lutheran Hospital. Index people with TB (PWTB) will be consecutively recruited to passively track their TB course and that of their household contacts over a 2-month period
No interventions assigned to this group
Conditional Cash Transfer Incentive for Household Contact Screening
Households with index people with TB (PWTB) will be consecutively recruited and offered a conditional cash transfer once all HHCs complete the facility-based tuberculosis (TB) screening procedures. The participants will be notified of the cash transfer during the consenting process for this phase. They will be informed that if all household contacts complete the recommended TB screening, the cash transfer will be given to the head of household during the home visit at 2 months.
Conditional Cash Transfer Incentive for Household Contact Screening
Households with index people with TB (PWTB) will be consecutively recruited and offered a conditional cash transfer once all HHCs complete the facility-based tuberculosis (TB) screening procedures. The participants will be notified of the cash transfer during the consenting process for this phase. They will be informed that if all household contacts complete the recommended TB screening, the cash transfer will be given to the head of household during the home visit at 2 months.
Interventions
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Conditional Cash Transfer Incentive for Household Contact Screening
Households with index people with TB (PWTB) will be consecutively recruited and offered a conditional cash transfer once all HHCs complete the facility-based tuberculosis (TB) screening procedures. The participants will be notified of the cash transfer during the consenting process for this phase. They will be informed that if all household contacts complete the recommended TB screening, the cash transfer will be given to the head of household during the home visit at 2 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* Residing or receiving TB care outside of the catchment area of study sites
* Prior completion of TB screening procedures for all household members.
ALL
No
Sponsors
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Burroughs Wellcome
INDUSTRY
The American Society of Tropical Medicine and Hygiene
OTHER
University of Virginia
OTHER
Responsible Party
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Ghassan Ilaiwy
Visiting Assistant Professor Department of Medicine, Division of Infectious Diseases and International Health
Principal Investigators
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Tania Thomas, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Haydom Lutheran Hospital
Haydom, Manyara Region, Tanzania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSR230322
Identifier Type: -
Identifier Source: org_study_id
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