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

MacPherson, P. , Webb, E. L., Variava, E., Lala, S. G., Milovanovic, M., Ratsela, A., Lebina, L., Kinghorn, A. and Martinson, N. A. (2019) Intensified household contact tracing, prevention and treatment support versus enhanced standard of care for contacts of tuberculosis cases in South Africa: study protocol for a household cluster-randomised trial. BMC Infectious Diseases, 19, 839. (doi: 10.1186/s12879-019-4502-5) (PMID:31606032) (PMCID:PMC6790042)

Abstract

Background Household contact tracing of index TB cases has been advocated as a key part of TB control for many years, but has not been widely implemented in many low-resource setting because of the current dearth of high quality evidence for effectiveness. Innovative strategies for earlier, more effective treatment are particularly important in contexts with hyper-endemic levels of HIV, where levels of TB infection remain extremely high. Methods We present the design of a household cluster-randomised controlled trial of interventions aimed at improving TB-free survival and reducing childhood prevalence of Mycobacterium tuberculosis infection among household contacts of index TB cases diagnosed in two provinces of South Africa. Households of index TB cases will be randomly allocated in a 1:1 ratio to receive either an intensified home screening and linkage for TB and HIV intervention, or enhanced standard of care. The primary outcome will compare between groups the TB-free survival of household contacts over 15 months. All participants, or their next-of-kin, will provide written informed consent to participate. Discussion Evidence from randomised trials is required to identify cost-effective approaches to TB case-finding that can be applied at scale in sub-Saharan Africa.

• Item Type: Articles
• Additional Information: This study is funded by a UK/South African MRC Newton Fund Grant.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: MacPherson, Professor Peter
• Authors: MacPherson, P., Webb, E. L., Variava, E., Lala, S. G., Milovanovic, M., Ratsela, A., Lebina, L., Kinghorn, A., and Martinson, N. A.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
• Journal Name: BMC Infectious Diseases
• Publisher: BioMed Central
• ISSN: 1471-2334
• ISSN (Online): 1471-2334
• Copyright Holders: Copyright © The Author(s)
• First Published: First published in BMC Infectious Diseases 19:839
• Publisher Policy: Reproduced under a Creative Commons licence