Julie Bottero1, Anders Boyd, Joël Gozlan, Fabrice Carrat, Maud Lemoine, Hayette Rougier, Brigitte Varsat, Nicolas Boo, Cécile Charlois-Ou, Anne Collignon, Olivier Cha, Pauline Campa, Philippe Dhotte, Pierre-Marie Girard, Karine Lacombe. 1. aSorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136) bDepartment of Virology, St Antoine Hospital, AP-HP cINSERM U1135 CIMI dDepartment of Public Health eDepartment of Hepatology, St Antoine Hospital, AP-HP fCaisse Primaire d'Assurance Maladie (CPAM), Département des Examens Périodiques de Santé de l'Adulte (DEPSA) gMairie de Paris, Direction de l'Action Sociale, de l'Enfance et de la Santé hMairie de Paris, Centre de dépistage anonyme et gratuit (CDAG) de Belleville iMairie de Paris, Laboratoire St Marcel jPoliclinique Baudelaire, St Antoine Hospital, AP-HP kMairie de Paris, CDAG du Figuier lDepartment of Infectious Diseases, St Antoine Hospital, AP-HP, Paris, France.
Abstract
OBJECTIVES: Worldwide, many infected individuals are unaware of their hepatitis B virus (HBV) status. We evaluated the effectiveness of HBV rapid testing in promoting linkage-to-care. METHODS:In 2012, volunteers were recruited from five Parisian centers. Participants were randomized 1 : 1 to receive standard serology (S) or rapid testing (VIKIA-HBsAg/Quick Profile anti-HBsAb) with confirmatory serology (R+S). The primary endpoint was percentage of individuals with appropriate linkage-to-care (nonimmunized individuals starting vaccination or HBsAg-positive individuals receiving medical evaluation). The secondary outcomes were percentage receiving HBV-test results and performance of HBV rapid tests. RESULTS: In total, 995 individuals were screened. Among the HBV-infection groups included in the primary endpoint (n=409), 20 (4.9%) received appropriate linkage-to-care, with no difference between S and R+S groups (5.7 vs. 4.1%, P=0.5). Two of eight HBsAg-positive participants had a medical visit (1/6 and 1/2 in the S and R+S groups, respectively) and 18/401 (4.5%) nonimmunized participants initiated HBV-vaccination (11/205 and 7/196). Factors that tended to be associated with linkage-to-care were female sex, birth country of high HBV prevalence, and extended medical stay. Test results were not obtained in 4.7% of participants, which was significantly higher in the S arm (P=0.02). Both sensitivity and specificity were 100% for the VIKIA-HBsAg rapid test and 94.4 and 80.8%, respectively, for the anti-HBsAb Quick Profile rapid test. CONCLUSION: Despite a higher proportion of participants obtaining their results in the R+S arm and better performance of anti-HBsAb rapid tests than described previously, we found no evidence that HBV screening based initially on rapid tests leads to increased HBV-vaccination rates or medical evaluation. This strategy should be evaluated in more hard-to-reach populations.
RCT Entities:
OBJECTIVES: Worldwide, many infected individuals are unaware of their hepatitis B virus (HBV) status. We evaluated the effectiveness of HBV rapid testing in promoting linkage-to-care. METHODS: In 2012, volunteers were recruited from five Parisian centers. Participants were randomized 1 : 1 to receive standard serology (S) or rapid testing (VIKIA-HBsAg/Quick Profile anti-HBsAb) with confirmatory serology (R+S). The primary endpoint was percentage of individuals with appropriate linkage-to-care (nonimmunized individuals starting vaccination or HBsAg-positive individuals receiving medical evaluation). The secondary outcomes were percentage receiving HBV-test results and performance of HBV rapid tests. RESULTS: In total, 995 individuals were screened. Among the HBV-infection groups included in the primary endpoint (n=409), 20 (4.9%) received appropriate linkage-to-care, with no difference between S and R+S groups (5.7 vs. 4.1%, P=0.5). Two of eight HBsAg-positive participants had a medical visit (1/6 and 1/2 in the S and R+S groups, respectively) and 18/401 (4.5%) nonimmunized participants initiated HBV-vaccination (11/205 and 7/196). Factors that tended to be associated with linkage-to-care were female sex, birth country of high HBV prevalence, and extended medical stay. Test results were not obtained in 4.7% of participants, which was significantly higher in the S arm (P=0.02). Both sensitivity and specificity were 100% for the VIKIA-HBsAg rapid test and 94.4 and 80.8%, respectively, for the anti-HBsAb Quick Profile rapid test. CONCLUSION: Despite a higher proportion of participants obtaining their results in the R+S arm and better performance of anti-HBsAb rapid tests than described previously, we found no evidence that HBV screening based initially on rapid tests leads to increased HBV-vaccination rates or medical evaluation. This strategy should be evaluated in more hard-to-reach populations.
Authors: Helena Medina Cruz; Leticia de Paula Scalioni; Vanessa Salete de Paula; Juliana Custódio Miguel; Kycia Maria Rodrigues do Ó; Flavio Augusto Pádua Milagres; Marcelo Santos Cruz; Francisco Inácio Bastos; Priscila Pollo Flores; Erotildes Leal; Ana Rita Coimbra Motta-Castro; Lia Laura Lewis-Ximenez; Elisabeth Lampe; Livia Melo Villar Journal: Mem Inst Oswaldo Cruz Date: 2017-01-30 Impact factor: 2.743