Screening of Children in Household Contact With Adult TB Patients in Mbarara Hospital, Uganda
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      The proposed study aims to establish a pilot program through a prospective cohort study
      offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB
      disease to children <5 years living in the same household as adults diagnosed with
      smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital
    

Detailed description: 
      Because children with tuberculosis (TB) are usually smear-negative and therefore less
      infectious, they are generally not considered a public health risk. Up to 70% of children
      living in the same household with an adult with infectious TB will become infected, and more
      than 20% of them will develop active TB disease, usually within 12 months. The individual
      risk of developing disease once infected is highest in children <5 years. In addition,
      children under 5 years are at higher risk of developing disseminated forms of TB. The impact
      of childhood TB is worsened by co-infection with HIV. Contact tracing, investigation and
      prophylaxis of childhood contacts of adult TB cases are widely recommended but rarely
      practiced in developing countries. The World Health Organization recommends that all NTPs
      screen household contacts for symptoms of disease and offer isoniazid preventive therapy
      (i.e. daily isoniazid for at least 6 months) to children aged less than 5 years and to all
      HIV-infected children who are household contacts. In Mbarara, an area with a high incidence
      of TB, no program currently exists for the routine investigation of child contacts of adult
      pulmonary TB cases. Almost all child TB cases registered are found through the evaluation of
      symptomatic children, often long after the adult source-cases have been investigated and
      treated. The number of adult cases with pulmonary TB, together with the population structure
      in Mbarara (>50% of the total population being children) suggests that the number of
      childhood TB cases is probably higher than current hospital records indicate.

      The proposed study aims to establish a pilot program through a prospective cohort study
      offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB
      disease to children <5 years living in the same household as adults diagnosed with
      smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital. The study will
      also generate much needed data on the utility of simple symptom-based screening of child
      contacts for TB disease in areas where access to radiological examination and tuberculin skin
      test are limited and on the efficacy and safety of IPT, in a region with a significant
      problem of HIV co-infection.

      Children aged 1 month to 5 years living in the same household (a house or cluster of houses
      on the same plot) with a newly diagnosed adult case of smear and/or culture-positive TB will
      be eligible for the study. Children will undergo a physical examination, chest Xray,
      tuberculin skin test and specimen collection in case of symptoms. Children will then be
      classified as active TB, TB infected and non infected cases. TB infected and non infected
      children will receive 6 months isoniazid prophylaxis with monthly monitoring of acceptability
      and tolerability. A final clinical assessment will be performed at 9 months. A total of 577
      children contacts will be enrolled.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 1 month to 5 years living in the same household (a house or cluster of houses
        on the same plot) with a newly diagnosed adult case of smear and/or culture-positive TB
        will be eligible for the study
      
Keywords: contact