The HomeACF Study: A household cluster randomised trial of case-finding and intensive prevention for HIV and TB

Lead Research Organisation: Wits Health Consortium

Abstract

Tuberculosis and remains a major public health priority in South Africa and other high HIV prevalence countries. Current TB control strategies in Africa have shown limited effectiveness in achieving the rapid reductions in TB incidence required of new global strategies. Previous studies have shown that rates of undiagnosed TB and HIV are high in household contacts of TB cases, making them a priority group for individual and public health action to improve health and reduce infection spread. We therefore propose to investigate the effectivness and cost-effectiveness of a strategy based around intensive screening, prevention and supported access to care for the household contacts of TB patients diagnosed in health facilities in two provinces of South Africa. Rates of new TB, and previously undiagnosed TB and HIV in households randomly allocated to receive the intensive screening, prevention and access to care intervention will compared to households allocated to receive an enhanced standard of care intervention comprising of referral letters and follow-up telephone calls. Study results will help inform strategies to improve TB control in the region.

Technical Summary

Tuberculosis transmission occurs predominantly indoors, often at home. We propose this trial to assess whether an improved and intensified household intervention for household contacts of TB cases prevents TB infection and disease in two different TB burden settings. Households of index TB cases diagnosed in health facilities in the North West and Limpopo Provinces of South Africa will be randomly allocated to receive either an enhanced standard of care contact tracing strategy using referral letters with follow-up phone calls, or an intensified contact tracing and treatment support intervention comprising of: sputum Xpert screening for all household contacts and culture for symptomatic individuals;HIV testing and supported linkage to ART; and TB preventive therapy for HIV-positive and TST negative HIV-negative contacts. The primary outcome will compare between groups TB-free survival between months 3-15 after index case recruitment. Secondary outcomes will compare prevalence of MTB infection in children, prevalence of undiagnosed HIV and TB, cohort outcomes, and cost-effectivenes.

Publications

10 25 50
 
Description Presentation of baseline household prevalence data to South African TB Think Tank, and to researchers and policy makers - gives credence to universal testing for TB and not use symptoms as a basis.
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description South African MRC supplemental funding
Amount R 2,600,000 (ZAR)
Funding ID Exisiting SA MRC Newton award supplement. 
Organisation Medical Research Council of South Africa (MRC) 
Sector Public
Country South Africa
Start 09/2018 
End 07/2019
 
Description TB RePORT
Amount $750,000 (USD)
Organisation National Institute of Allergy and Infectious Diseases (NIAID) 
Sector Public
Country United States
Start 09/2016 
End 08/2019
 
Description One Health 
Organisation University of Pretoria
Department Faculty of Veterinary Science
PI Contribution With Prof Anita Michelle at the University pf Pretoria Faculty of Veterinary Science, we are including collection of preliminary data to alow us to assess potential for interspecies transmission of mycobacteria. M bovis from livestock and M tuberculosis from humans to livestock and domestic animals.
Collaborator Contribution Provided expert advice on the potential of mycobacterial transmission between humans and animals.
Impact Non yet
Start Year 2017
 
Description Briefing to National TB Control Programme, Department of Health South Africa. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Requested to provide update to on Contact Tracing in Households of TB index cases to senior members of the national TB control program in South Africa.
Year(s) Of Engagement Activity 2016
 
Description TSG Workshop at the ACTG Meeting in Washington: Titel: Screening for TB in various populations; opportunities for IPT. 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presented to the TB Translational Science Group (TSG) of the Adult Clinical Trials Group (ACTG) of the United States National Institutes of Health (NIH) in Washington.
Year(s) Of Engagement Activity 2016