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NCT Number: NCT06971952

Tuberculosis in Rural and Malnourished Populations

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

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Malnutrition Mycobacterium Infections Nutrition Disorders Nutritional and Metabolic Diseases Tuberculosis Undernutrition

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conditional Cash Transfer Incentive for Household Contact Screening

Behavioral

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.

Primary outcomes

  1. TB screening completion for all HHCs before the study-initiated home visit

    Time frame: From enrollment to the time of home visit at 2 months

    TB screening completion for all HHCs before the study-initiated home visit; this is a feasible outcome with significant impact on downstream steps in the TB prevention cascade. Population level statistics related to facility-based TB screening in Manyara region are unpublished. Based on findings from our pilot study, we anticipate conditional cash transfers to achieve >50% completion of TB screening for HHCs compared to <15% at baseline (anticipate improvement of TB screening completion to 15% at baseline compared to the 7% baseline noted prior to our pilot study due to closer follow up)

  2. Quantify the effect of undernutrition severity on the progression to active TB disease

    Time frame: one year

    We anticipate that HHCs with moderate-to-severe undernutrition at baseline will be 60% more likely to develop active TB disease at one year compared to HHCs with appropriate nutritional status. MUAC will have similar performance to other measures of undernutrition in the context of HHC TB screening

Secondary outcomes

  1. The cost-effectiveness of conditional cash transfer added to the current facility-based approach to improve TB screening among HHCs of index PWTB

    Time frame: 20-year time horizon for the cost-effectiveness model

    Formative data on household expenditures and distance to care from our pilot study as well as prospective findings from this study will inform a Markov state transition model of comparative cost-effectiveness that will find a cash-transfer strategy most cost-effective for completion of HHC TB screening

Study contacts

Contact information is provided by the study sponsor or research team.

Ghassan Ilaiwy, MD MPH

CONTACT

[email protected]

434.297.9460

Tania A. Thomas, MD MPH

CONTACT

[email protected]

434.243.9592

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Burroughs Wellcome
  • The American Society of Tropical Medicine and Hygiene

Registry information

Official study title

Closing the Tuberculosis Diagnosis Gap in Rural and Malnourished Populations

Acronym: TB-RAMP

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 14, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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