Intensified household contact tracing, prevention and treatment support versus enhanced standard of care for index tuberculosis cases in South Africa: a cluster-randomised trial

Chris Hani Baragwanath Hospital0 个研究点目标入组 2,400 人开始时间: 2017年2月1日最近更新: 2024年6月18日

试验速览

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31606032/ protocol (added 06/01/2021) 2021 Results article in https://doi.org/10.1093/cid/ciab1047 (added 04/08/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32182274/ Baseline data analysis of latent TB infection among household contacts of index cases (added 04/06/2024)

•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

•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

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