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The PEOPLE trial on post exposure prophylaxis for leprosy

E Hasker(1) Y Assoumani(2,8) A Randrianantoandro(3) S Ramboarina(4) S Braet(1) B Cauchoix(4) A Baco(2,8) A Mzembaba(2) Z Salim(2) M Amidy(2) S Grillone(2) N Attoumani(2) S Grillone(2) M Ronse(1) K Peeters(1) H Harinjatovo(3) P Supply(5) R Snijders(1) C Hoof(1) P Suffys(6) T Rasamoelina(7) N Ortuno-Gutierrez(8) A Geluk(9) E Cambau(10) B C de Jong(1)

1:Institute of Tropical Medicine, Antwerp; 2:National Tuberculosis and Leprosy control Program, The Union of Comoros; 3:National Leprosy control Program Madagascar; 4:Fondation Raoul Follereau, Antananarivo, Madagascar; 5:Genoscreen SAS, Lille, France; 6:Oswaldo Cruz Institute, Fiocruz, Laboratory of Molecular Biology Applied to Mycobacteria, Rio de Janeiro, Brazil; 7:Centre d’Infectiologie Charles Mérieux, Antananarivo, Madagascar; 8:Damien Foundation, Brussels, Belgium; 9:Leiden University Medical Center, Leiden, the Netherlands; 10:Assistance publique-Hopitaux de Paris, Paris, France

Introduction: Post-exposure prophylaxis with single dose rifampicin (SDR-PEP) can block progression from infection with M.leprae to leprosy disease. In the PEOPLE trial we assessed effectiveness of different modalities of SDR-PEP.

Methods: We randomized 64 villages (total population 110,660) in Comoros and Madagascar to four study arms. In each arm we conducted four rounds of annual door-to-door screening and treated all leprosy patients identified. In arm 1 nothing else was done, in arms 2-4 we also provided SDR-PEP to all household contacts. In arm 3 SDR-PEP provision was extended to anyone living within 100 meters of an index case, in arm 4 SDR-PEP was also offered to anyone living within 100 meters and testing positive to anti-PGL-I.  We compiled incidence rate ratios (IRR) of leprosy between the comparator arm (arm 1) and each of the intervention arms and explored spatial associations.

Results: We found some reduction in incidence in arms 3 (IRR 0.8) and 4 (IRR 0.6) but differences were not statistically significant. Controlling for baseline prevalence there was a borderline significant reduction in arm 3, IRR 0.5 (98.3% CI 0.3-1.0). At individual level SDR-PEP was protective (IRR 0.6, 95% CI 0.4-0.9). Risk of leprosy was two to four times higher for those living up to 75 meters of an index case.

Discussion/conclusion: SDR-PEP appears to protect but less than expected. We found strong spatial associations up to 75 meters from index cases.  Most impact on transmission can be expected from well targeted door-to-door screening, to which SDR-PEP can add. 

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