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

Disclosures

J Viral Hepat. 2021;28(2):345-352. 

In This Article

Results

Baseline Characteristics and Results of the RE&IC Questionnaire

The four participating primary care centres attended approximately 136 360 patients during the study period, with a higher prevalence of women (58%) and 69.8% being between 15–75 years of age. A total of 7991 participants were included in the study, who filled out the RE&IC questionnaire. There were 65.9% women, and the median age was 43 (IQR 33–53) years. The qualitative data obtained from the nursing staff surveys indicate that approximately 30% of the people who were offered to participate in the study rejected it. Refusals were more frequent among middle-aged (30–50 years) men. Table S1 shows the demographics and relevant study characteristics of all included participants, with a breakdown by each of the four primary care centres. Most participants (40.6%) had a secondary education, followed by 33.3% with university degrees, and 25.1% with a primary education. The most frequent place of origin was Spain (75.5%), followed by Latin America (15.4%). In the two years prior to entry into the study, 87% made at least one visit to a primary care provider, 59% to another hospital specialist, 42% to the emergency department, and 20% to an occupational health physician. However, only 17.8% had been HIV tested during the same period.

Of 7991 participants, 4670 (58.5%) answered affirmatively to at least one question, who were considered individuals at risk for HIV, while 2894 (36.2%) answered affirmatively to any HCV-related questions. Table 1 shows the results of the RE&IC questionnaire by population groups. Regarding risk of exposure assessment for both HIV and HCV infections, the younger participants, men and those from Latin America and Eastern Europe, showed the greatest risk of presenting a positive questionnaire. The indicator conditions were more frequently reported by women and older participants, showing greater differences in HCV than in HIV. A multivariable predictive model was created to discriminate population groups that present an independent association with the positive or negative result of the questionnaire, finding an area under the ROC curve less than 0.6 in all cases, indicating that no group could be excluded a priori from completing the questionnaire.

Results of HIV and HCV Rapid Testing

Of the total of 7991 participants, 4670 (58.5%) had at least one positive response in the questionnaire, so they underwent the rapid HIV test. Regarding HCV screening, 2894 (36.2%) positive RE&IC questionnaires were obtained. Moreover, 2557 patients were over 50 years old and were consequently tested. Of these, 571 (22.3%) presented a positive questionnaire for risk of exposure and 443 (17.3%) for indicator conditions. Finally, 4717 HCV tests were performed (Figure 1). In 2% of individuals with a positive questionnaire the rapid test was not performed, in most cases based on the patient's refusal. This was mainly due to a poor understanding of the study protocol, since they reported lack of time to take the test after completing the questionnaire.

Figure 1

The overall screening coverage was higher within the DRIVE-03 program than in control arm (OR 17.7; 95% CI 16.2–19.5; P < .001). Table 2 shows the differences between study arms with respect to HIV screening. Two HIV-positive results were obtained (0.44‰), both early diagnoses and correctly linked to care. Regarding HCV, from a total of 4717 tests performed, 50 (1.1%) were positive. Of these, 2 (4%) were false positive after confirmatory tests, 11 (22%) were patients with known and previously treated HCV infection, 10 (20%) were new HCV diagnoses, and 27 (54%) were patients with some previous positive determination for HCV, but who were not aware of it or were not linked to health care (Table 3). With regard to new diagnoses, 26 cases (96%) had an active HCV infection, while one (4%) presented spontaneous clearance. Of the total positive tests, 30 (60%) were in participants over 50. Of these, 4 (13%) did not report any risk factors in the questionnaire.

Among the total number of patients with active HCV infection, 53% were women, with a median age of 51 years (IQR 49–55); 85% were of Spanish nationality, 9% were from Eastern Europe, and 3% were from Latin America. No significant differences were found in age (P = .550), gender (P = 1.000), degree of fibrosis (P = .390) or the model for end-stage liver disease (MELD) score (P = .174) between new diagnoses and patients with previously diagnosed infection. Thirty-five out of 36 patients with active infection were correctly linked, receiving antiviral treatment, and in all cases achieving sustained virological response at week 12.

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