title: Effect of household and community interventions on the burden of tuberculosis in southern Africa: the ZAMSTAR community-randomised trial.
abstract: BACKGROUND
  Southern Africa has had an unprecedented increase in the burden of tuberculosis, driven by the HIV epidemic. The Zambia, South Africa Tuberculosis and AIDS Reduction (ZAMSTAR) trial examined two public health interventions that aimed to reduce the burden of tuberculosis by facilitating either rapid sputum diagnosis or integrating tuberculosis and HIV services within the community.
  
  
  METHODS
  ZAMSTAR was a community-randomised trial done in Zambia and the Western Cape province of South Africa. Two interventions, community-level enhanced tuberculosis case-finding (ECF) and household level tuberculosis-HIV care, were implemented between Aug 1, 2006, and July 31, 2009, and assessed in a 2×2 factorial design between Jan 9, 2010, and Dec 6, 2010. All communities had a strengthened tuberculosis-HIV programme implemented in participating health-care centres. 24 communities, selected according to population size and tuberculosis notification rate, were randomly allocated to one of four study groups using a randomisation schedule stratified by country and baseline prevalence of tuberculous infection: group 1 strengthened tuberculosis-HIV programme at the clinic alone; group 2, clinic plus ECF; group 3, clinic plus household intervention; and group 4, clinic plus ECF and household interventions. The primary outcome was the prevalence of culture-confirmed pulmonary tuberculosis in adults (≥18 years), defined as Mycobacterium tuberculosis isolated from one respiratory sample, measured 4 years after the start of interventions in a survey of 4000 randomly selected adults in each community in 2010. The secondary outcome was the incidence of tuberculous infection, measured using tuberculin skin testing in a cohort of schoolchildren, a median of 4 years after a baseline survey done before the start of interventions. This trial is registered, number ISRCTN36729271.
  
  
  RESULTS
  Prevalence of tuberculosis was evaluated in 64,463 individuals randomly selected from the 24 communities; 894 individuals had active tuberculosis. Averaging over the 24 communities, the geometric mean of tuberculosis prevalence was 832 per 100,000 population. The adjusted prevalence ratio for the comparison of ECF versus non-ECF intervention groups was 1·09 (95% CI 0·86-1·40) and of household versus non-household intervention groups was 0·82 (0·64-1·04). The incidence of tuberculous infection was measured in a cohort of 8809 children, followed up for a median of 4 years; the adjusted rate ratio for ECF versus non-ECF groups was 1·36 (95% CI 0·59-3·14) and for household versus non-household groups was 0·45 (0·20-1·05).
  
  
  CONCLUSIONS
  Although neither intervention led to a statistically significant reduction in tuberculosis, two independent indicators of burden provide some evidence of a reduction in tuberculosis among communities receiving the household intervention. By contrast the ECF intervention had no effect on either outcome.
  
  
  BACKGROUND
  Bill & Melinda Gates Foundation.
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK. helen@zambart.org.zm
authors.forename: Helen
authors.initials: H
authors.lastname: Ayles
authors.forename: Monde
authors.initials: M
authors.lastname: Muyoyeta
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Du Toit
authors.forename: Ab
authors.initials: A
authors.lastname: Schaap
authors.forename: Sian
authors.initials: S
authors.lastname: Floyd
authors.forename: Musonda
authors.initials: M
authors.lastname: Simwinga
authors.forename: Kwame
authors.initials: K
authors.lastname: Shanaube
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Chishinga
authors.forename: Virginia
authors.initials: V
authors.lastname: Bond
authors.forename: Rory
authors.initials: R
authors.lastname: Dunbar
authors.forename: Petra
authors.initials: P
authors.lastname: De Haas
authors.forename: Anelet
authors.initials: A
authors.lastname: James
authors.forename: Nico C
authors.initials: NC
authors.lastname: Gey van Pittius
authors.forename: Mareli
authors.initials: M
authors.lastname: Claassens
authors.forename: Katherine
authors.initials: K
authors.lastname: Fielding
authors.forename: Justin
authors.initials: J
authors.lastname: Fenty
authors.forename: Charalampos
authors.initials: C
authors.lastname: Sismanidis
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
authors.forename: Nulda
authors.initials: N
authors.lastname: Beyers
authors.forename: Peter
authors.initials: P
authors.lastname: Godfrey-Faussett
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000553:Ambulatory Care / Q000379:methods*; D060085:Coinfection / Q000453:epidemiology; D003153:Community Health Services / Q000458:organization & administration*; D005260:Female; D015658:HIV Infections / Q000453:epidemiology* / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D017678:Sex Distribution; D013019:South Africa / Q000453:epidemiology; D014397:Tuberculosis, Pulmonary / Q000453:epidemiology* / Q000517:prevention & control; D055815:Young Adult; D015024:Zambia / Q000453:epidemiology