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Randomized Controlled Trial
. 2019 Oct 12;19(1):839.
doi: 10.1186/s12879-019-4502-5.

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

Peter MacPherson  1   2 , Emily L Webb  3 , Ebrahim Variava  4   5 , Sanjay G Lala  5   6 , Minja Milovanovic  5 , Andrew Ratsela  7 , Limakatso Lebina  5 , Anthony Kinghorn  5 , Neil A Martinson  4   5
Affiliations
Randomized Controlled Trial

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

Peter MacPherson et al. BMC Infect Dis. .

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.

Trial registration: ISRCTN16006202 (01/02/2017: retrospectively registered) and NHREC4399 (11/04/2016: prospectively registered). Protocol version: 4.0 (date: 18th January 2018).

Keywords: Case-finding; Cluster randomised trial; HIV; Prevention; Screening; South Africa; Sub-Saharan Africa; Treatment; Tuberculosis.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

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