Tuberculosis and human immunodeficiency virus infection Infections and Infestations
Conditions
Interventions
Index TB cases (defined as any patient, living or recently deceased who is a permanent resident of one of the study districts and who has been diagnosed with TB [if older than 5 years: bacteriological
if five years or younger: clinically diagnosed by a doctor, or bacteriologically-confirmed TB of any organ] at any health facility in the study districts in the six weeks prior to recruitment) will be
Sponsors
Chris Hani Baragwanath Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Index TB cases eligible to participate in the study will be: 1. Patient (living or recently deceased), diagnosed with TB within six weeks before recruitment (recently deceased is defined as within the 6 weeks before recruitment) 2. Permanent resident in study District and living with at least one other household member for at least 3 months in the last 6 months before recruitment 3. No plan of relocation to another municipality or health district during the 15 months follow-up period 4. If older than 7 years of age: laboratory confirmation of pulmonary TB (either a positive sputum result for acid fast bacilli, or a positive sputum Xpert MTB/Rif test result; or a positive sputum culture for M. tuberculosis) 5. If 7 years old or younger: a child with signs and symptoms suggestive of TB recorded in clinic or hospital record, and a recorded diagnosis of TB in a clinic or hospital record, and the prescription of TB treatment by a doctor
Exclusion criteria
Exclusion criteria: 1. Unwilling to provide informed consent or assent 2. Unable to obtain informed consent from the parents/legal guardian for those younger than 18 years 3. Unable to obtain informed consent from close next of kin of adult patients who are too ill to provide their own consent or have died 4. Patient with TB who appears to have developed or contracted TB while institutionalized or imprisoned 5. Imprisoned or institutionalized at the time of diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TB-free survival from randomisation to the final ascertainment visit (a total follow-up time of 15 months). This is a composite outcome: the follow-up time for those reaching the endpoint will be the time from randomisation or date of becoming a permanent household member to date of loss to follow-up or the date of the 15-month outcome ascertainment visit; the follow-up time for those not reaching the endpoint will be the time from randomisation or date of becoming a permanent household member to date of tuberculosis diagnosis or to date of death (or if both occur during the follow-up, the earliest of these). All analyses will be done using two different definitions of TB: (1) including all cases where TB was diagnosed or multi-drug TB treatment started, irrespective of the diagnostic method; (2) including only those with a hard copy of a laboratory confirmation of TB. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of TB infection, measured by tuberculin skin test reactivity >10mm at month 15 among household children who are aged under 14 years of age at outcome assessment 2. Time between onset of symptoms and initiation of anti-tuberculosis treatment, among household members diagnosed with TB between baseline and month 15 3. Prevalence of previously undiagnosed or untreated HIV infection (reported as a percentage of those tested at 15 months) 4. Cumulative incidence of all-cause mortality at 15 months 5. Community HIV load, defined as the prevalence of detectable viraemia within each trial arm 6. Estimation of the cost-effectiveness of the intensified household contact tracing and treatment support intervention compared to the enhanced standard of care from a societal perspective | — |
Countries
South Africa
Contacts
Public ContactCharity Leeuw
Outcome results
None listed