Tuberculosis in Rural and Malnourished Populations (TB-RAMP)

University of Virginia

Status: Not yet enrolling

Conditions: Tuberculosis (TB); Undernutrition

Treatments: Behavioral: Conditional Cash Transfer Incentive for Household Contact Screening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06971952

HSR230322

Details and patient eligibility

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

Enrollment: 360 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Facility-based Household Contact Screening

No Intervention group

Description:

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

Conditional Cash Transfer Incentive for Household Contact Screening

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conditional Cash Transfer Incentive for Household Contact Screening