Hepatitis C and HIV combined screening in primary care: A cluster randomized trial.

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.

An Easy-to-Implement Risk Score for Targeted Hepatitis C Virus Testing in the General Population.

Despite the effectiveness of available treatments, hepatitis C virus (HCV) remains a major public health problem, mainly due to the high percentage of undiagnosed individuals. We aim to create an easy-to-implement risk score to facilitate targeted HCV testing in the general population. This is a substudy derived from a prospective study in primary care in Madrid (Spain). Participants completed a 21-question risk assessment questionnaire, followed by HCV testing for those with at least one positive response and those >50 years of age, even if they did not answer positively. We used the population >50 years of age to fit a logistic regression model to create a score predicting the risk of a positive test result. We then performed a sensitivity analysis by applying the score obtained to the population <50 years of age, to assess its diagnostic accuracy. Data collected from 2,302 participants were included in the analysis. The prevalence of HCV infection was 1.3%. Five items were selected, showing a C-statistic of 0.896, i.e., male sex, Eastern European origin, use of intravenous drugs, self-perceived risk of acquired HCV infection, and past hepatitis or unexplained liver disease. The sensitivity was 98%, and the negative likelihood ratio was 0.05 for participants with scores of 0 (49.8% in our sample), ruling out HCV infection with high probability. We obtained similar estimates in the population <50 years of age. This tool achieved high diagnostic accuracy to target HCV testing. This could help optimize resources when universal screening is not feasible. IMPORTANCE Despite the highly effective treatments currently available, HCV remains one of the major public health problems related to an infectious agent, mainly because a high percentage of individuals remain undiagnosed. Universal screening has been proposed as a way to end this epidemic; however, it is not feasible in all settings due to different implementation barriers. With this work, we aim to collaborate in improving the diagnosis of HCV infection by creating a simple 5-item score that rules out HCV infection with a very high probability. Almost one-half of the participants in our sample did not present any affirmative answers to these questions, and their probability of being infected was close to 0%. This tool could be a useful strategy and could be considered a cost-effective alternative to optimize resources when universal screening is not feasible.

Prevalence of HCV infection in a health area of Madrid (Spain): The first step towards microelimination. / Prevalencia de la infección por el VHC en un área sanitaria de Madrid: el primer paso para la microeliminación.

OBJECTIVE: To estimate the prevalence of HCV infection in the general population of a health area through an intervention in Primary Care, differentiating between new diagnoses and infections previously diagnosed but not treated. METHODS: Participants were selected through a risk assessment questionnaire, with all those who gave at least one affirmative answer and all those over 50 years of age undergoing a rapid test. Positive tests were confirmed in the lab by determination of anti-HCV antibodies by chemiluminescent microparticle immunoassay and determination of viraemia. RESULTS: Of the 7,991 participants, 36.2% presented a positive HCV risk questionnaire. 4,717 tests were performed, finding an anti-HCV percentage of 0.65% in the screened population, with 0.46% of active infections. Among the individuals with a positive test result, 51.9% had a known prior diagnosis but had not received treatment, because they were not aware of it or were not linked to the health system, and 19.2% had a positive result for the first time. The prevalence of hidden infection was higher in men, those over 50 years of age and people from Eastern Europe. CONCLUSION: We found a prevalence of active infections higher than recently described nationwide, and a higher percentage of newly diagnosed infections than recent similar studies in other areas. These differences justify the need to perform local assessments of the prevalence of HCV infection in each of the health areas where it is planned to implement and monitor a microelimination programme.

Impact of a structured HIV testing program in a hospital emergency department and a primary care center.

INTRODUCTION: HIV testing guidelines are poorly implemented in most clinical settings. The best screening strategy and healthcare scenario are still unknown. The aim of our study is to evaluate the impact of a structured HIV testing intervention (DRIVE), compared to HIV testing as routinely performed in clinical practice, in two different clinical settings: a primary care center and an emergency department. METHODS: Prospective evaluation of an HIV testing strategy in two clinical settings from the same healthcare area. The DRIVE program included trained nurse practitioners to perform the screening, a questionnaire to assess the risk of exposure and HIV indicator conditions (RE&IC), and rapid HIV tests. The main variables between the DRIVE program and clinical practice were the absolute number of newly diagnosed HIV infections and testing coverage. RESULTS: The DRIVE program included 5,329 participants, of which 51.2% reported at least one positive answer in the questionnaire. The estimated HIV testing coverage was significantly higher in the DRIVE program than in the routine clinical practice (7.17% vs. 0.96%, p < 0.001), and was better in the primary care center than in the emergency department with the two strategies. Twenty-two HIV-positive people were identified, with a rate of 8.6‰ in the emergency department vs. 2.2‰ in the primary care center (p = 0.001). A higher rate of new HIV diagnoses was found in the DRIVE program compared to routine clinical practice (29.6 vs. 3.1 per 100,000 patients attended; p < 0.001). CONCLUSIONS: An easy-to-implement, structured intervention increased the absolute number of new HIV diagnoses and HIV tests, compared to routine clinical practice.

Development and Validation of an HIV Risk Exposure and Indicator Conditions Questionnaire to Support Targeted HIV Screening.

The aim of our study was to develop a Spanish-structured HIV risk of exposure and indicator conditions (RE&IC) questionnaire. People attending to an emergency room or to a primary clinical care center were offered to participate in a prospective, 1 arm, open label study, in which all enrolled patients filled out our developed questionnaire and were HIV tested. Questionnaire accuracy, feasibility, and reliability were evaluated.Valid paired 5329 HIV RE&IC questionnaire and rapid HIV tests were performed, 69.3% in the primary clinical care center, 49.6% women, median age 37 years old, 74.9% Spaniards, 20.1% Latin-Americans. Confirmed hidden HIV infection was detected in 4.1%, while HIV RE&IC questionnaire was positive in 51.2%. HIV RE&IC questionnaire sensitivity was 100% to predict HIV infection, with a 100% negative predictive value. When considered separately, RE or IC items sensitivity decreases to 86.4% or 91%, and similarly their negative predictive value to 99.9% for both of them. The majority of people studied, 90.8% self-completed HIV RE&IC questionnaire. Median time to complete was 3 minutes. Overall HIV RE&IC questionnaire test-retest Kappa agreement was 0.82 (almost perfect), likewise for IC items 0.89, while for RE items was lower 0.78 (substantial).A feasible and reliable Spanish HIV RE&IC self questionnaire accurately discriminated all non-HIV-infected people without missing any HIV diagnoses, in a low prevalence HIV infection area. The best accuracy and reliability were obtained when combining HIV RE&IC items.

Comparison of routine versus targeted HIV testing strategies: coverage and estimated missed infections in emergency room and primary care centre.

INTRODUCTION: Different HIV Testing Strategies (TS) and clinical care settings had not been face to face evaluated (1). We compared coverage, Newly Diagnosed HIV Infection (NDHI) and Estimated Missing HIV Infections (MHI) in Hospital Emergency Room (HER) and Primary Care Center (PCC), in DRIVE study (Spanish acronym of HIV infection Rapid Diagnosis) and in clinical practice the year before DRIVE. MATERIALS AND METHODS: In DRIVE study, 18-60 years old, non-HIV-infected population visiting an HER or a PCC were proposed both a structured risk practices and clinical conditions questionnaire (RP&CC-Q) and a rapid HIV test. This arm is the HIV Routine TS. We analyze a hypothetical arm, where risk practices were universally assessed with an RP&CC-Q, subsequently risk-positive patients where HIV tested, Targeted-TS. Coverage was assessed as the ratio of tested population (TP)/attended population (AP) in HER and PCC. TP/AP ratios were also calculated in the year before, the Clinical Practice-TS. NDHI was expressed per ‰ tests performed. MHI was estimated assuming in the non-tested population, overall DRIVE rate of NDHI ‰ and NDHI ‰ in negative RP&CC-Q. RESULTS: A total of 5329 RP&CC-Q and rapid HIV tests were performed to 49.64% women, median age 37 (28-47) years old, mainly 74.9% Spaniards. Confirmed NDHI was 4.1‰, and in 48, 8% of RP&CC-Q negative NDH was 0‰. HIV screening coverage was always better in PCC than in HER, and higher in DRIVE study than in clinical practice. Estimated MHI was higher in HER and in the clinical practice-TS. Targeted-TS coverage was lower, but resulted in similar NDHI and MHI than routine-TS, testing half the population, see Table 1. CONCLUSIONS: Best HIV Testing Strategy is routine-TS in Primary Care Center. Targeted-TS resulted in same newly HIV diagnoses and missed HIV infections than routine-TS with half the resources employed.

Incremental cost per newly diagnosed HIV infection (NDHI): routine (RTS), targeted (TTS), and current clinical practice testing strategies (CPTS).

INTRODUCTION: Although RTS as HIV Diagnosis was considered cost effectiveness [1], overall budget may be unaffordable for some countries. We explore Incremental cost per NDHI associated with different TS. MATERIALS AND METHODS: From a health care perspective, using direct costs and Euros currency, we calculated budget and cost per NDHI of RTS (all patients were tested), TTS (Universal risk practices and clinical conditions-RP&CC - only positive were tested), and CPTS (Only patients physicians considered were tested). We considered DRIVE (Spanish acronym of HIV infection Rapid Diagnosis) study and clinical Practice outcomes. Population between 18-60 years, attending to a Hospital Emergency Room or to a Primary Care Center performed an HIV RP&CC questionnaire (Q) and an HIV rapid test (HIV RT). Unitary costs considered were: HIV RT, nurse, registry, transport and HIV confirmation when necessary, imputed to all population in RTS and CPTS and only in HIV RP&CC-Q positive in TTS analysis, while HIV RP&CC-Q costs were added to all population in TTS. Sensitivity analyses were performed with varying rates of NDHI and of positive HIV RP&CC-Q population, and different RP&CC Q sensitivity (SE) to predict HIV infection. RESULTS: 5,329 HIV RP&CC-Q and HIV RT were performed to 49.64% women, median age 37 years old, 74.9% Spaniards. In DRIVE and CP, NDHI were 4.1‰, and 1.6‰, while HIV RP&CC-Q was positive in 51.2%. HIV RP&CC-Q SE was 100%. Overall budget employed in HIV testing was in RTS 43,503€, in TTS 24,472€ and in CPTS 5,032€. Cost per 1 NDHI was 1,977€, 1,112€ and 5,032€, respectively. A reduction in cost of 865€, favouring TTS vs. RTS, while an increased cost of 824€ in CPTS vs. RTS was obtained. Considering NDHI rate of 2.6‰ saving costs increased to 1379€ in TTS, while were reduced to 576€ if NDHI rate increases 6.2‰. Effect of RP&CC-Q positivity rate was similar, if 25% saving costs were 1368€, while if 75% were reduced to 399€. Varying SE of RP&CC-Q to 95%, 91% and 50% cost saving was 810€, 754€, and 208€, and number of MHI one, two and 11. CONCLUSIONS: In DRIVE study Targeted TS with universal screening of RP&CC before an HIV rapid test is cost saving, without missing NDHI, with respect to Routine TS. Lower rates of HIV infection and RP&CC in the population, increase costs savings.

Prevalencia de la infección por el VHC en un área sanitaria de Madrid: el primer paso para la microeliminación / Prevalence of HCV infection in a health area of Madrid (Spain): The first step towards microelimination

OBJETIVO: Estimar la prevalencia de la infección por VHC en la población general de un área sanitaria a través de una intervención en Atención Primaria, diferenciando entre nuevos diagnósticos e infecciones previamente diagnosticadas pero no tratadas. MÉTODOS: Se seleccionaron participantes mediante un cuestionario de evaluación de riesgo, realizando un test rápido a todos aquellos con alguna respuesta afirmativa y a todos los mayores de 50 años. Las pruebas positivas se confirmaron en el laboratorio mediante determinación de anticuerpos frente al VHC por enzimoinmunoensayo de micropartículas quimioluminiscente y determinación de la viremia. RESULTADOS: Del total de 7.991 participantes, el 36,2% presentó cuestionario de riesgo para VHC. Se realizaron 4.717 test, encontrando una proporción de anti-VHC de 0,65% en la población cribada, quedando en 0,46% de infecciones activas. El 51,9% de las personas con test positivo tenían un diagnóstico previo conocido pero no habían recibido tratamiento, por no ser conscientes de ello o no encontrarse vinculados al sistema sanitario, y el 19,2% tuvo un resultado positivo por primera vez. La prevalencia de infección oculta fue mayor en hombres, mayores de 50 años, y personas procedentes de Europa del Este. CONCLUSIÓN: Encontramos una prevalencia de infecciones activas superior a la descrita recientemente a nivel nacional, y con mayor porcentaje de pacientes nuevamente diagnosticados que en trabajos similares en otras áreas. Estas diferencias justifican la necesidad de realizar evaluaciones locales de la prevalencia de infección por VHC en cada una de las áreas de salud donde se plantee implementar y monitorizar un programa de microeliminación

OBJECTIVE: To estimate the prevalence of HCV infection in the general population of a health area through an intervention in Primary Care, differentiating between new diagnoses and infections previously diagnosed but not treated. METHODS: Participants were selected through a risk assessment questionnaire, with all those who gave at least one affirmative answer and all those over 50 years of age undergoing a rapid test. Positive tests were confirmed in the lab by determination of anti-HCV antibodies by chemiluminescent microparticle immunoassay and determination of viraemia. RESULTS: Of the 7,991 participants, 36.2% presented a positive HCV risk questionnaire. 4,717 tests were performed, finding an anti-HCV percentage of 0.65% in the screened population, with 0.46% of active infections. Among the individuals with a positive test result, 51.9% had a known prior diagnosis but had not received treatment, because they were not aware of it or were not linked to the health system, and 19.2% had a positive result for the first time. The prevalence of hidden infection was higher in men, those over 50 years of age and people from Eastern Europe. CONCLUSION: We found a prevalence of active infections higher than recently described nationwide, and a higher percentage of newly diagnosed infections than recent similar studies in other areas. These differences justify the need to perform local assessments of the prevalence of HCV infection in each of the health areas where it is planned to implement and monitor a microelimination programme