Community Initiated Preventive Therapy for TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      Background: The World Health Organization (WHO) currently recommends household contact
      investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an
      emphasis on pediatric contacts. Although the aim of this policy is to find previously
      undetected TB patients and reduce transmission, such investigations represent a missed
      opportunity to start contacts without TB on preventive therapy (TPT). The WHO guidelines do
      not address the optimal implementation of contact investigation. The standard of care (SOC)
      in most settings, passive referral of pediatric contacts to the clinic by the index TB
      patient, has largely remained unsuccessful in practice. In 2017, the WHO estimated only 23%
      of eligible child contacts were started on TB preventive therapy. Household contact
      investigation has been shown to have a higher yield in active TB case finding, but is labor
      intensive, and may be challenging to implement in densely populated urban settings or
      informal settlements/slums. The WHO recently endorsed the use of a new TPT regimen
      (rifapentine and isoniazid weekly (3HP)) for both children and adults in high burden
      settings, and the programmatic roll out of this regimen offers the opportunity to
      simultaneously examine new strategies to improve the identification and treatment of
      pediatric TB household contacts.

      Objective: To compare the effectiveness of community-based versus facility-based child
      contact investigation and delivery of TB preventive care to inform the optimal implementation
      strategy for investigating pediatric household TB contacts.

      Study Design: Cluster-randomized trial in 32 clinics (16 clinics per arm) divided equally
      among South Africa and Ethiopia (8 clinics per arm per country).

      Methods: Newly diagnosed qualifying TB index patients (determined by South African or
      Ethiopian National TB guidelines) and participants' household child contacts will be
      recruited to participate. Local staff, including the relevant nurses and community health
      workers in the intervention and control clinics, will be trained to conduct contact
      investigation with a symptom-based approach for all child contacts under 15 years old in home
      and at the clinic. Data will be collected using routine medical files and then
      retrospectively abstracted by the research team. Thirty-two primary health clinics will be
      stratified (by TB case notification and by country) and randomized in 1:1 fashion to either
      community-based or facility-based delivery of care. Household child contacts under 15 years
      of age who screen negative for TB disease will be initiated on TPT by a healthcare worker
      (nurse, community health worker, etc.) either in the home or clinic setting. Children in the
      intervention arm who screen positive will first be sent to the nurse at the clinic for repeat
      screening. Children who have a persistently positive screen in the intervention arm and those
      with a positive screen in the control arm using South Africa's or Ethiopia's pediatric
      symptom screening tool will be referred to a physician at the district hospital for further
      investigation of TB disease, as is the standard of care in both settings. Investigators will
      compare clinic-level outcomes including proportion of household TB contacts under 15 years of
      age that were screened, initiated on TPT, and who completed TPT, and reasons for not
      completing TPT including loss to follow up and incident TB disease while on TPT.
    


Intervention name(s): Community-Based TPT Initiation
Intervention type(s): Other
Intervention description(s): Community-based care delivery model for pediatric tuberculosis evaluation and initiation of preventive therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomized trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention