Community Initiated Preventive Therapy for TB

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    2000
  • sponsor
    Johns Hopkins University
Updated on 21 September 2021

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.

Details
Condition Tuberculosis, tb (tuberculosis)
Treatment Community-Based TPT Initiation
Clinical Study IdentifierNCT04369326
SponsorJohns Hopkins University
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria for Index Patient in South Africa
Adult pulmonary TB patient being treated for pulmonary TB disease (with bacteriologic confirmation including smear, GeneXpert MTB/RIF and/or liquid mycobacterial culture) in one of the participating clinics
Willing to have a home visit and disclose their diagnosis to household members
Lives in the catchment areas of a study clinic
Age 18 years or older
Provides informed consent
Inclusion Criteria for Index Patient in Ethiopia
Adult or child being treated for pulmonary TB disease (clinical with or without microbiologic diagnosis) in one of the participating clinics
Willing to have a home visit and disclose their diagnosis to household members
Lives in the catchment areas of a study clinic
Age 18 years or older
Provides informed consent
Inclusion Criteria for Contact in South Africa
Child less than 15 years old living in the household of the TB index patient
Caregiver willing to provide informed consent
Children 7 years and older must also provide assent
Inclusion Criteria for Contact in Ethiopia
Child less than 15 years old living in the household of the TB index patient
Caregiver willing to provide informed consent
Children 12 years and older must also provide assent

Exclusion Criteria

Exclusion Criteria for Index Patient in South Africa and Ethiopia
Extrapulmonary TB with no evidence of concurrent pulmonary TB
Evidence of rifampin and/or isoniazid resistance on GeneXpert MTB/RIF or drug sensitivity testing performed on M. tuberculosis isolates identified on culture
Household has already participated in study (more than one index patient in the household) and child contacts under 15 years have already been evaluated and remain on TPT and/or TB treatment
Exclusion Criteria for Contact in South Africa
Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert MTB/RIF OR drug sensitivity testing on isolates identified by culture)
Exclusion Criteria for Contact in Ethiopia
Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert MTB/RIF OR drug sensitivity testing on isolates identified by culture)
Household contact 15 years and older
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