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RecruitingNCT06971952TB-RAMPUpdated May 5, 2026

Tuberculosis in Rural and Malnourished Populations

An interventional study of Conditional Cash Transfer Incentive for Household Contact Screening in Tuberculosis (TB) and Undernutrition, sponsored by University of Virginia. Recruiting at 1 site in Tanzania. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Virginia · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Non-randomized
Sex
All
01

Study 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

02

Conditions studied

  • Tuberculosis (TB)
  • Undernutrition

Keywords

  • Tuberculosis
  • Active case finding
  • Undernutrition
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's planned enrollment of 360 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Inability to provide , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • No intervention
    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

  • Active comparator
    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.

    Behavioral: Conditional Cash Transfer Incentive for Household Contact Screening

Interventions

  • BehavioralConditional 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.

06

What researchers measure

Primary outcomes

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

    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)

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

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

    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

    Time frame: one year

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

    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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06971952
Collaborators
Burroughs Wellcome, The American Society of Tropical Medicine and Hygiene
Responsible party
Ghassan Ilaiwy (Visiting Assistant Professor Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia) — Principal investigator
First posted
May 14, 2025
Start date
Sep 1, 2025
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2030 (estimated)
Last update
May 5, 2026

Study contacts

Ghassan Ilaiwy, MD MPH
Contact
tmq5gp@uvahealth.org
434.297.9460
Tania A. Thomas, MD MPH
Contact
TAT3X@uvahealth.org
434.243.9592
Tania Thomas, MD MPH
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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