Hepatitis C and HIV Combined Screening in Primary Care

A Cluster Randomized Trial

Javier Martínez-Sanz; María Jesús Vivancos; Matilde Sánchez-Conde; Cristina Gómez-Ayerbe; Lidia Polo; Cristina Labrador; Patricia González; Alba Mesa; Alfonso Muriel; Clotilde Chamorro; Yolanda de la Fuente; Pilar Pérez Elías; Almudena Uranga; Margarita Herrero; Sara Ares; Rafael Barea; Santiago Moreno; María Jesús Pérez-Elías


J Viral Hepat. 2021;28(2):345-352. 

In This Article

Abstract and Introduction


Hepatitis C virus (HCV) and HIV are major causes of worldwide disease. We aimed to evaluate the effect of a combined screening programme, which included a risk-assessment questionnaire and rapid tests for point-of-care diagnosis, on screening and new diagnosis rates. This prospective, cluster randomized study was carried out in primary care. The intervention arm included a 4-hour educational programme, the use of a risk-assessment questionnaire and rapid tests. In the control centres, only the educational intervention was provided. The main variables compared were the screening coverage and the number and rate of new HCV and HIV diagnoses. Of a total of 7991 participants, 4670 (58.5%) and 2894 (36.2%) presented a risk questionnaire for HIV or HCV, respectively. The younger participants, men and those from Latin America and Eastern Europe, showed the greatest risk of presenting with a positive questionnaire. The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2–19.5; P < .001). Only two HIV-positives were identified compared to one in control centres. The rate of HCV diagnoses was higher among intervention centres, with 37 versus seven positive tests (OR 5.2; 95% CI 2.3–11.6; P < .001). Of them, 10 were new diagnoses and 27 had been previously diagnosed, although not linked to care. In conclusion, a simple operational programme can lead to an increase in HCV and HIV screening rates, compared to an exclusively educational programme. The selection of at-risk patients with a self-questionnaire and the use of rapid tests significantly increased the diagnostic rate of HCV infection.


The delay in the diagnosis of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection is one of the main current challenges in public health, since it is associated with an increase in mortality[1] and a higher probability of onward transmission due to uncontrolled viral replication.[2,3] The late diagnosis rate of HIV stands at approximately 50% in Western countries.[4] Despite this, there is still no clear screening strategy in patients who do not exhibit clinical manifestations, in whom a diagnosis in earlier stages would be expected.[5] With reference to HCV, it is estimated that 71 million people live with this infection (1% of the global population).[6] As with HIV infection, early diagnosis of HCV infection has clear benefits, such as the reduction of liver sequelae of chronic infection, which is essentially cirrhosis and hepatocellular carcinoma.[7] In contrast with the newly revised AASLD HCV testing guidelines, which support one time HCV testing for all adults,[8] some European guidelines, including the Spanish ones, continue to recommend targeted screening for populations with high known prevalence of infection or risk behaviours.[9]

Primary care centres most frequently perform HIV screening,[10] and different studies agree about the high prevalence of missed opportunities for HIV testing in these settings.[11,12] In the same sense, studies that examine primary care providers' HCV testing practices revealed low screening rates.[13,14] In addition, there may be some limiting factors for screening, such as patient non-reporting of current or historical risk, perceived irrelevance of risk-factor assessment to the primary care visit, and scepticism of the overall benefits outlined in the guidelines.[15]

Due to similarity in risk factors and transmission, and the high prevalence of HCV/HIV coinfection,[6] an overlap in screening services has been proposed. This combined screening could effectively use existing resources to address both epidemics and facilitate the linkage of HCV-infected individuals to health care.[16] Combined HCV/HIV testing interventions have been evaluated in both emergency rooms and drug use treatment centres[16,17] but, to our knowledge, it has not been assessed in the primary care setting. However, evaluation in a primary care setting is particularly interesting, as expanding effective testing interventions to primary care clinics will be key to meeting WHO goals for HIV and viral hepatitis elimination.

The objective of this study is to evaluate the impact of targeted HCV and HIV screening in primary care, guided by a self-administered questionnaire to determine the risk of infection, and using rapid test for point-of-care testing. We hypothesize that this structured testing programme will achieve higher screening and new diagnosis rates than a programme that includes only an educational strategy for primary care providers.