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


This study, conducted in the setting of primary care with a large sample size, shows that it is possible to improve HCV and HIV testing rates by implementing a structured screening strategy, which has proven superior to a programme in which only an educational activity is included. Moreover, the selection of at-risk patients with a simple self-questionnaire and the use of rapid tests at the point of care showed a clear impact on the diagnostic rate of patients with HCV infection, with greater uncertainty in the case of HIV due to the low prevalence found in the current sample screened.

During the study period, thanks to the external resources invested, HCV and HIV screening rates were more than 15 times higher in the intervention group. Despite this increase in screening, the rate of new diagnoses of HIV infection remains low in our health area. Previous studies in the same health area found rates of new HIV diagnoses higher than 2‰,[22,23] while five years later the incidence was 0.44‰. Although no definitive conclusions can be drawn, these data may indicate that the low prevalence of chronic occult infection currently existing in our area may be due to the effectiveness of screening programmes implemented in recent years,[18,23] as well as to the progressive decrease in the global incidence of HIV infection.[24] Moreover, patient characteristics included in the study could explain in part this low number of HIV diagnoses, since there is a high representation of women and people over 50 years of age.

In contrast, diagnoses of HCV infection increased significantly, both newly diagnosed participants and those previously diagnosed but not linked to care. Interventions to improve screening for HCV infection have been useful since the era prior to the use of direct-acting antivirals, and those that include direct testing seem better than those that include only general measures.[25] There is little experience in the use of rapid tests for HCV screening in primary care. Recent studies show an adequate feasibility and acceptability in a population of active addicts, although given the population included, the linkage to care is lower.[17] Different strategies are being developed to simplify the screening process and improve diagnosis rates. These include one-step diagnostic schemes,[26] the creation of active search programmes for patients with positive serology, and alert programmes for primary care physicians when a positive serology exists for hepatitis C. The implementation of universal screening has been widely debated,[27] although most of the projects currently underway focus on the micro- elimination of the epidemic in at-risk population groups, such as intravenous drug users, inmates or men who have sex with men who engage in at-risk practices.[28] Our study shows the importance of establishing HCV and HIV elimination programmes in the general population, since a high percentage is not currently included in high-risk groups, being the greatest opportunity for diagnosis in primary care. Our questionnaire showed that the risk of exposure was higher in men and in younger individuals, which is consistent with the epidemiological data described in our environment,[24] as well as in people from South America and Eastern Europe, where a greater prevalence is described for HIV (and HCV in the case of Eastern Europe).[6] Nevertheless, indicator conditions were more frequently reported by women and older people, in which higher rates of late diagnosis are described in Spain.[11]

In this study, only 22% of patients older than 50 reported some risk factor for HCV infection, in addition to age. In 2012, the Centers for Disease Control and Prevention (CDC) in the United States recommended the HCV test to all people born between 1945 and 1965, known as 'baby boomers', in whom there is a high prevalence of HCV infection.[29] Since then, several European studies were conducted to evaluate the feasibility of birth-cohort HCV screening, suggesting that each country must determine its own seroprevalence per year to develop screening recommendations.[30] In Spain, and in our own cohort, the highest prevalence of HCV infection was found in those born between 1955 and 1970.[31] Our study also shows that not all diagnosed patients over 50 years reported other risk factors; therefore, although the screening strategy based on the risk of exposure and indicator conditions seems useful in this population, it may not be sufficient to diagnose the total number of patients in this age group.

This study has several limitations. The use of the questionnaire for HCV screening is considered exploratory since it has not been previously validated. In order to facilitate the statistical analysis as well as the understanding of the results, we have analysed data on an individual level despite of having conducted the intervention at the cluster level. Besides, the crossover design may lead to a bias due to the Hawthorne effect. The sample of mostly female and elderly people does not correspond to the groups where a higher incidence of HIV and HCV infection is currently described; however, it is representative of the general population attended in primary care in our setting, and includes the population with the highest prevalence of late diagnosis.[11] The lack of data about refusals by group demographics may introduce a selection bias; nevertheless, we consider that participants are representative of the population that would accept to be screened in real life in this setting, therefore, our results present an adequate external validity. One of the main strengths of this study is that it was performed in primary care. There is evidence of multiple strategies carried out to improve the diagnosis of infection through rapid tests in places not restricted only to high-risk environments, such as pharmacies or mobile units in community settings.[32] However, primary care centres are the health resource most frequently used by the Spanish population to undergo HIV screening. This study shows that a simple operational programme, including a nursing-assisted screening, with a selection of patients through a risk-assessment questionnaire and the use of rapid tests, led to an improvement in HCV and HIV screening rates, compared to an exclusively educational programme, in a primary care setting of a Western Europe country. New HCV diagnoses, as well as participants previously diagnosed but not linked to care, increased significantly, thereby showing a high percentage of active infections subsidiary to antiviral therapy.