Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia
Conditions: Hepatitis C Virus Infection
Sponsor: Asociación Colombiana de Hepatología

 
 
 
ADULT SCREENING FOR HEPATITIS C AND LINKAGE TO TREATMENT 
IN HOSPITALS IN COLOMBIA 
 
 
 
STUDY PROTOCOL 
 
 
 
 
Principal Investigator 
Javier Hernández Blanco 
Gastroenterologist and Hepatologist 
Colombian Association of Hepatology 
 
 
 
 
 
Bogotá, Colombia 
November 2023 
 

 
2 
 
1 
Problem statement and justification 
Hepatitis C virus (HCV) infection is a major cause of chronic hepatitis, cirrhosis, and liver 
cancer. For some people, hepatitis C is a short-term disease, but for more than half of the 
people who become infected with the hepatitis C virus, it becomes a long-term chronic 
infection (1). The risk of developing cirrhosis for people with chronic HCV infection ranges 
from 15% to 30% over 20 years (2).  
According to 2019 data from the World Health Organization (WHO), there are 58 million 
people are living with chronic hepatitis C infection, and each year there are about 1.5 million 
new infections, it causes 290,000 deaths per year, mainly from cirrhosis and/or 
hepatocellular carcinoma (2). 
The World Health Organization (WHO) in 2016 defined the global strategy for the elimination 
of viral hepatitis (hepatitis C virus and hepatitis B), the goals for hepatitis C include a 90% 
decrease in new cases of infection and a 65% reduction in mortality (3). To achieve this goal 
by 2030, 90% of people living with hepatitis C virus need to be diagnosed and 80% of these 
individuals should receive treatment along with a reduction of HCV incidence in high-risk 
groups (4, 5). 
While good progress has been made in several countries, a significant testing and treatment 
gap remains. In 2019, only 21% of the 58 million with chronic hepatitis C infection had been 
diagnosed; overall, 13% were treated (3). 
The introduction of direct-acting antivirals (DAAs) for HCV treatment in 2013 has led to 
sustained viral response (SVR) rates greater than 95% after 8 to 12 weeks of treatment, 
which is a significant advance in the elimination strategy (6), but massive screening and 
treatment implementation programs are needed to translate the potential of DAA treatment 
into population-level benefits (7). 
The scale-up of DAA treatment is essential to achieve HCV targets, but this is a huge public 
health challenge. A major obstacle is under-diagnosis; only 20% of people with HCV 
worldwide have been diagnosed (6), and only 1% of infected people have received treatment 
worldwide. The effectiveness of governments and their partners in designing and 
implementing effective screening strategies to identify the "missing millions" will be a critical 
determinant of the speed with which elimination can be achieved (8). 

 
3 
 
Despite the effectiveness of DAAs and that in Colombia they are covered by the health 
system, the main obstacle to achieving the goal of hepatitis C elimination is under-diagnosis. 
Among the barriers to timely diagnosis are lack of knowledge on the part of health 
professionals, availability and access to screening tests, as well as stigma and 
discrimination, as a country it is required to directly address these barriers to advance in the 
goals of elimination of viral hepatitis (9). Simplifying the HCV care cascade, ideally across 
all steps of the continuum of care, would help ensure that more patients remain engaged in 
the care pathway and ultimately achieve WHO goals (10). 
In Colombia, according to SIVIGILA, an average of 228 cases of hepatitis C were reported 
per year in the period between 2011 and 2016, starting in 2017 there was a significant 
increase with the notification of 571 cases and continued increase in 2018 (886 cases) and 
2019 (897 cases) (11), in 2020 (473 cases) and in 2021 (878 cases), which represent an 
incidence of 1.70 per 100,000 inhabitants (9).  
In 2017, the centralized drug purchasing strategy for the treatment of chronic hepatitis C 
was implemented, in compliance with Resolution 1692, as part of the effort to eradicate viral 
hepatitis from the country. The strategy is to purchase Direct Action Antiviral (DAA) drugs 
directly from the Ministry of Health and Social Protection (MSPS) to guarantee access and 
reduce treatment costs. When Resolution 1692 of 2017 was issued, the strategy was applied 
only to people diagnosed with chronic hepatitis C in the contributory regime; however, since 
January 2020, access to centralized purchasing by the subsidized regime was achieved 
(12). 
According to information from the High-Cost Account (CAC for its acronym in Spanish), 
between January 1st and December 31st, 2021, 962 persons with the infection were identified 
in Colombia (13). According to the probable mechanism of transmission, the highest 
proportions are sexual transmission (72.1%) and parenteral/percutaneous (11.8% of cases) 
(14). According to information published by the Polaris Observatory up to 2021, there is a 
prevalence of 0.67% (320,000 cases), 10% of cases have been diagnosed, and of these 
<1% have been treated and 2639 deaths have been registered annually. According to their 
predictions with the current behavior, it is estimated that by the year 2051 Colombia will 
achieve the goals established by the WHO (15). 
Three-quarters of HCV-infected people live in low- to middle-income countries, some of 

 
4 
 
which lack budgets for screening, diagnosis, and treatment campaigns. In 2018, Polaris 
Observatory reported that only 12 countries were on schedule to meet HCV elimination 
targets by 2030, these countries were Australia, Egypt, France, Georgia, Iceland, Italy, 
Japan, Mongolia, the Netherlands, Spain, Switzerland, and the United States (6).  
Prevalence studies for HCV have been conducted in less than half of the countries in Latin 
America, and most of them are of poor-quality design. Extrapolating data from countries with 
registries, the estimated HCV prevalence rate in Latin America is less than 1%. Estimates 
made by the Polaris Observatory, according to epidemiological data from the online 
database in 2019, several countries were able to diagnose a significant percentage of the 
population with HCV infection; however, only Brazil was able to treat the required number 
of patients to achieve an annual net cure of more than 1% of those infected (16). 
A study modeling the impact of DAA treatment on the course of HCV infection showed that 
achieving the WHO 2030 targets would require a net cure of 7% per year from 2016. "Net 
cure" was defined as the number of persons with sustained virologic response, minus new 
HCV infections, plus HCV-related deaths (17). 
The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases 
Society of America (IDSA), and the Center for Disease Control (CDC) recommend one-time, 
routine, opt-out HCV screening for all persons aged 18 years and older. Additionally, (18): 
• 
HCV testing should be performed at least once for all persons with activities, exposures, 
or conditions or circumstances associated with an increased risk of HCV infection, 
occasionally testing should be done periodically if risk conditions persist.  
• 
Perform HCV testing for all pregnant women as part of prenatal care.  
• 
Annual HCV testing is recommended for all persons who inject drugs, for HIV-infected 
men who have unprotected sex with men, and for men who have sex with men taking 
pre-exposure prophylaxis. 
The WHO recommends that in places where the general population has a high 
seroprevalence of anti-HCV antibodies (defined as a seroprevalence of 2% or higher, or 5% 
or higher), to provide access to HCV screening tests to all adults and to offer them such 
tests in linkage with prevention, care and treatment services (2). 
To date, no HCV infection prevalence studies have been conducted in the general 

 
5 
 
population in Colombia, which could represent a drawback for decision-making for the 
control and elimination of HCV infection. However, studies in blood donors and populations 
with and without risk factors provide important data to know the overall situation of HCV 
infection in the country, and modeling analysis has contributed to the strategy in the country 
(Decree No. 1692 of 2017) (11). For Colombia, it is expected that approximately 409,000 
people will have the infection in 2030 (9). 
In Colombia, the Ministry of Health and Social Protection established in 2018 the National 
Response Plan for STIs, HIV, TB/HIV coinfection, and hepatitis B and C 2018-2021. In 2018, 
the clinical practice guideline for the diagnosis and treatment of hepatitis C infection was 
updated (14), likewise, progress has been made in the implementation of financing 
strategies for DAAs, however, it is still pending to improve screening strategies that do not 
only focus on risk factors and at the same time have generic treatment options available (9). 
The country's achievements and challenges in hepatitis C correspond to (13): 
• 
Timely identification of persons who have contracted the infection, so that they can 
quickly access treatment with direct-acting antivirals (DAAs).  
• 
Maintain the decrease in treatment initiation time and effectiveness above 95%, which 
translates into a higher rate of cure of the disease. 
• 
Staging for liver fibrosis to all patients at the time of diagnosis and decrease the 
progression of the disease to advanced stages. 
• 
Continue working on decreasing the progression of fibrosis, liver cirrhosis, hepatocellular 
cancer, and virus transmission. 
Through this observational, multicenter, hospital population study, the prevalence will be 
determined by screening patients with risk factors for hepatitis C by rapid antibody test, to 
subsequently perform confirmation with viral load PCR in those seropositive. In addition, 
support will be provided to patients to facilitate their treatment adherence.  
The benefits would be related to raising awareness of the importance of the active search 
for these patients, reducing the health impact for the screened population, incorporating 
these strategies in the country's hospital institutions, and obtaining epidemiological 
information that helps to understand the magnitude of the disease and the opportunity for 
its elimination. 

 
6 
 
2 
Theoretical framework and state-of-the-art  
In 2016, the World Health Assembly endorsed the elimination of viral hepatitis as a public 
health threat by 2030. WHO-recommended interventions are childhood immunization 
against hepatitis B, prevention of mother-to-child transmission of hepatitis B virus (HBV) 
through timely vaccination at birth against hepatitis B and other approaches, safe 
transfusions, harm reduction for people who inject drugs, and HBV and hepatitis C virus 
(HCV) testing and treatment (19). Since then, tremendous efforts have been underway to 
accelerate countries' progress toward HCV elimination through data collection, predictive 
modeling, and screening and treatment linkage projects (20). 
In May 2022, the 75th World Health Assembly took note of a set of comprehensive global 
health sector strategies against HIV, viral hepatitis, and sexually transmitted infections for 
the period 2022-2030. Building on the 2016 and new Assembly strategies, some Member 
States have developed comprehensive national hepatitis programs. To achieve the global 
viral hepatitis targets under the 2030 Agenda for Sustainable Development, the areas that 
should be worked on are a. raising awareness, promoting partnerships, and mobilizing 
resources for diagnosis and linkage to treatment; b. formulating evidence-based policies and 
compiling data for action; c. improving health equity in the hepatitis response; d. preventing 
transmission; and e. expanding screening, care, and treatment services (2). 
Chronic HCV infection can remain asymptomatic until the late stages, leading to low 
awareness of the patient's infection status and a significant proportion of undiagnosed 
individuals (21). HCV infection is diagnosed in two stages: a. Detection of anti-HCV 
antibodies with a serological test reveals infection. b. If the test is positive for anti-HCV 
antibodies, a nucleic acid test for HCV ribonucleic acid (RNA) (viral load) is needed to 
confirm chronic infection and the need for treatment (2). 
A study presented at the American Association for the Study of Liver Diseases (AASLD) 
Annual Meeting has concluded that the prevalence of viremic hepatitis C virus (HCV) 
infections declined from 66 million in early 2015 to 59 million in early 2020 (22); hepatitis C 
is a curable disease that if not diagnosed and treated on time can progress to liver cirrhosis, 
hepatocellular carcinoma, and death related to these and other hepatic or extrahepatic 
problems (20). The worldwide prevalence of HCV infection is estimated to be 0.75% (95% 
CI 0.6-0.8%) in the early 2020s (22).  

 
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Researchers at the Center for Disease Analysis Foundation (CDA) estimated from 2015 to 
2019 7.5 million new chronic HCV infections, 1.3 million newly diagnosed that year (22). By 
2019, of the 59 million HCV-infected persons worldwide, an estimated 21% (15.2 million) 
were diagnosed and, by the end of 2019, 9.4 million had been treated with Direct-Acting 
Antivirals (DAAs) (62% of persons diagnosed with chronic HCV infection), 8.8 million 
infections cured, and 5.5 million all-cause and liver-related deaths (2, 22). 
Globally, more than three-quarters of HCV viremic infections remained undiagnosed at the 
beginning of 2020, and more than 90% of people with active hepatitis C remained untreated 
with DAAs. In high-income countries in 2020, ADC researchers estimated that 6 million 
people had a viral infection, of whom 47% had been diagnosed and 11% of those diagnosed 
were receiving treatment. The percentage of people with active hepatitis C is estimated to 
be 27% in upper-middle-income countries, 15% in lower-middle-income countries, and 16% 
in low-income countries. As for the percentage of people diagnosed and treated with DAAs, 
it is 3 % in upper-middle-income countries, 4 % in lower-middle-income countries, and 4 % 
in low-income countries (23). 
In conclusion, the investigators note that DAA treatment is highly concentrated in a few 
countries, and low diagnosis rates and lack of large-scale HCV screening programs remain 
barriers to liver virus clearance. Despite the decrease in the number of cases versus 2015, 
these data suggest that currently, the world is still far from meeting global elimination targets 
by 2030 (23). 
Scaling up interventions for hepatitis screening and treatment from baseline to elimination 
targets, within the perspective of universal health coverage and in the context of the 
Sustainable Development Goals entails an additional 1.5% investment, but the effect is 
proportionally larger, leading to about a 5% reduction in mortality and a 10% increase in 
healthy life years (19). 
The recent WHO global health sector strategy sets new actions and targets to eliminate viral 
hepatitis by 2030 by reducing new infections to 90% and deaths to 65%, i.e., to half a million 
each worldwide.  For this to happen, care must be more accessible to more people in need. 
The recommendations given have the potential to substantially expand access to testing 
and treatment in low- and middle-income countries. The 3 new key recommendations 
include (3): a. Simplified service delivery and task sharing: testing, care, and treatment of 

 
8 
 
persons with chronic hepatitis C infection can be provided by non-specialist trained 
physicians and nurses so that care can be delivered in primary care facilities, harm reduction 
services, and prisons, which is more accessible and convenient for patients. b. More efficient 
and simplified hepatitis diagnostics: use of HCV ribonucleic acid (RNA) assays at the point-
of-care (POC) as an additional approach alongside laboratory-based RNA assays to 
diagnose infection. Especially applicable to marginalized populations, such as people who 
inject drugs, and hard-to-reach communities with limited access to care and high rates of 
loss to follow-up. c. Harmonized and simplified hepatitis treatment (3). 
For testing in all settings, WHO recommends testing focused on persons with signs and 
symptoms of chronic liver disease and groups with a high prevalence of HCV infection. 
However, if the prevalence of infection in the general population exceeds 2-5%, WHO 
recommends testing in the general population (19). WHO recommends treatment with 
pangenotypic direct-acting antivirals (DAAs) for all adults with chronic hepatitis C infection. 
In Colombia, according to data from the high-cost account, the currently available DAA 
sofosbuvir/velpatasvir achieves an efficacy of 98.7% of HCV-infected patients, and a 
treatment duration of 12 weeks (9). 
Early diagnosis of infection and linkage to treatment is one of the priority lines of action. 
Policies on HCV screening should be articulated in different settings (24). Key issues 
impeding HCV elimination are the lack of reliable and up-to-date estimates of active HCV 
infections and related disease burden (21). 
The WHO strategy defines ambitious targets to eliminate HCV as a public health threat by 
2030, to achieve which the scale-up of DAA treatment is essential, but this is a huge public 
health challenge. Identification of patients who are unaware of their HCV status represents 
the main barrier to be overcome, by 2017 according to WHO report only 20% of people with 
HCV worldwide had been diagnosed (6). Micro-elimination strategies targeting small 
fractions of the population, as opposed to nationwide elimination programs, have shown 
improvement in diagnosis and treatment rates resulting in great benefits in expanding the 
HCV care cascade and achieving WHO targets (21).  
According to the epidemiological situation of HCV infection in the general population and the 
most affected populations, and of the hepatitis C approach plans, the clinical guidelines of 
countries such as Spain, United Kingdom, Germany, France, Ireland, Canada or Australia 

 
9 
 
recommend population and opportunistic screening, i.e. HCV screening of persons with 
exposures and risk situations for infection such as injecting and/or inhaled drug use, risky 
sexual intercourse, HIV/HBV co-infection, cosmetic procedures performed with sharps 
without proper safety precautions, admission to correctional facilities (24), anyone who 
received blood transfusions before HCV serological testing of blood donors was initiated, 
who received medical or dental interventions in health care settings with substandard 
infection control practices (25). 
The indications for HCV screening by risk exposures instead of population screening allow 
focusing efforts and resources, responding to the principle of equity in the design, 
implementation, and evaluation of HCV screening programs in different territories, which 
allows addressing the barriers to access and use of services in each context (24). Targeted 
screening would identify a high rate of infected subjects, due to the higher rate of infection 
related to risk factors, and simultaneously reduce viral transmission by allowing HCV to be 
eliminated from individuals at higher risk of spreading the infection (26). 
The results of the study by Rosato, et al (2022) indicate that opportunistic hospital screening 
in patients with various comorbidities is a feasible strategy to diagnose and then easily link 
infected patients to care. They also clearly show the need for increased awareness among 
general practitioners and other health care specialists, who care for patients with different 
comorbidities, to address HCV disease management. This is also important because HCV 
eradication has been shown to significantly improve not only liver disease outcomes but also 
various comorbidities, such as cryoglobulinemic vasculitis, diabetes, cardiovascular and 
renal diseases, etc. (27). 
Care cascade monitoring (CoC) is an important component of the response to the global 
hepatitis C virus (HCV) epidemic. The function of a CoC is to represent how many members 
of a population have progressed through each stage in a sequence of stages required for 
effective disease control: e.g., diagnosis, treatment, and cure; the findings obtained will 
enable health system decision-makers to determine where the greatest gaps are in testing, 
linkage to care, and treatment among persons with chronic HCV infection (28). 
A hospital-centered HCV micro-elimination approach provides a framework for expanding 
linkages to care and treatment on the path to achieving WHO's 2030 targets (21). It is less 
complex and costly than large-scale national efforts to eliminate HCV, and it can build 

 
10 
 
momentum by producing small victories that inspire more ambitious efforts (6). Fragile 
populations require dedicated screening and integrated care programs, which can begin in 
hospitals and continue in a network involving all processes including telehealth (21), 
promoting the adoption of new models of care in specific populations (6). 
Micro-elimination approaches in populations at high risk for HCV transmission can 
potentially contribute to "treatment as prevention." The concept of treatment as prevention 
is to successfully treat an HCV-infected person at risk of transmitting HCV to others and 
eliminate the possibility of further transmission, thus achieving "prevention." While there is 
not yet a real-world demonstration of the potency of treatment as prevention, the model 
indicates that carrying out this strategy on a sufficiently large scale accelerates progression 
toward population elimination. The goal of treatment as prevention is to successfully treat 
enough people to reach a threshold at which new infections are significantly reduced. 
Because of the potential to prevent more infections, many of whom would incur the high 
costs of treating end-stage liver disease (6). 
Targeting those at the highest risk for disease may generate broader community benefits 
and long-term cost-effectiveness. In support of this approach to HCV eradication, modeling 
studies by Martin and colleagues (2011 and 2013) have indicated that chronic HCV 
prevalence could be reduced by treating those at risk for ongoing HCV transmission (29). 
The scale-up of HCV treatment is largely dependent on the availability and affordability of 
diagnostics and drugs. A large portion of the costs is attributable to testing because 
screening large numbers of people is required to identify 90% of those infected in low-
prevalence settings (19). 
Since 2017, in Colombia, the High-Cost Account (CAC) has been following up on cases 
identified with chronic hepatitis C infection, in compliance with the provisions of Resolution 
1692 of 2017, which is part of the centralized negotiation and purchase strategy for direct-
acting antivirals (30). 
According to the Follow-up report on cases with chronic hepatitis C under the centralized 
drug negotiation and purchase strategy - Cut-off June 30, 2020, in follow-up by the EPS on 
compliance with what is contemplated in the clinical pathway for the treatment of chronic 
hepatitis C, 634 cases and 326 cases were reported in the 2019 and 2020 cohort, 
respectively, for a total of 2,102 patients with a diagnosis of chronic hepatitis C reported to 

 
11 
 
the high-cost account (including those in the 2017-2018 cohort). Of the 634 users enrolled 
in the 2019 cohort, 584 initiated treatments, of which 97.6% (570) did so with centrally 
purchased drugs. Of the 326 cases included in the 2020 cohort, 219 initiated treatments, 
98.6% (216) with centrally purchased drugs, which made evident the almost exclusive use 
of the strategy, except in cases of stage 4-5 chronic kidney disease. Of the 1,142 patients 
reported to the CAC in 2017 and 2018, 1,079 had initiated treatment and of these 84.2% 
(n=909), were included in the centralized purchasing model, the most frequently used 
treatment in 98.2% of cases in the 2019-2020-2021 cohort was sofosbuvir/velpatasvir, 
reaching 98.77 in 2021 (12). 
Regarding the effectiveness of the treatment, it was found that for the 2017-2018 cohort, 
with centrally purchased drugs, the effectiveness was 95.1% and with drugs outside the 
centralized purchasing model it was 96.4%. For the 2019 cohort, the effectiveness was 98% 
and 100% respectively. In the 2020 cohort, treatment effectiveness is at 100% (12). 
The report concludes that there is high effectiveness of direct-acting antiviral treatments 
(greater than 95%), follow-up is observed in the application of the clinical route and 
practically exclusive use of drugs included in the centralized purchasing model; however, 
there is a need to encourage screening in the population over 50 years of age and according 
to risk exposure, as established in resolution 3280 of 2018 (12). 
3 
Research question 
What is the prevalence of HCV in the population with risk factors for hepatitis C virus 
infection captured by screening with rapid tests in health care institutions in Colombia? 
4 
Objectives 
4.1 
General objective 
To determine the prevalence of HCV in patients with risk factors for HCV captured through 
opportunity screening in the hospital institutions included. 
4.2 
Specific objectives 
• 
Characterize the study population socio-demographically. 
• 
Describe the epidemiological characteristics of HCV antibody-positive patients. 

 
12 
 
• 
Determine the proportion of patients with positive HCV antibodies and positive viral load 
(quantitative) for HCV. 
• 
Perform an exploratory analysis of the association of positive cases and the different risk 
factors for HCV infection. 
• 
Quantify how many HCV-positive individuals were able to access the management 
pathway and treatment. 
5 
Methodology 
5.1 
Type of study 
Descriptive multicenter cross-sectional study.  
5.2 
Study population 
All persons over 18 years of age who are treated in the included health care institutions 
(IPS) and who are users of hospitalization, emergency, outpatient and any other hospital 
care services. 
5.3 
Inclusion criteria 
Have at least one of the following risk factors for hepatitis C. 
• 
Over 50 years of age with no risk factors. 
• 
Over 18 years old and < 50 years old, with risk factors for hepatitis C: 
✓ 
Persons who have received medical or dental interventions in health care 
settings. 
✓ 
Persons who have had tattoos, body piercings, or scarification procedures.   
✓ 
Persons with HIV or hepatitis B infection.  
✓ 
Persons who inject drugs.  
✓ 
Persons who have used intranasal drugs. 
✓ 
Persons deprived of liberty and previously incarcerated persons. 
✓ 
Anyone with abnormal liver tests or liver disease.  
✓ 
Students, health care workers, or members of public safety (e.g. correctional 

 
13 
 
service officers or police) who have come into contact with blood at work through 
needlestick or sharps injuries.  
✓ 
Anyone who has undergone hemodialysis.  
✓ 
Persons who received transfusions in Colombia before 1996. 
✓ 
Persons with comorbidities potentially associated with CH: diabetes, ischemic 
heart 
disease, 
cryoglobulinemia, 
chronic 
renal 
failure, 
Sjögren's 
syndrome, 
hypothyroidism, lichen planus, rheumatoid arthritis, HIV, non-Hodgkin's lymphoma, 
acute lymphoblastic leukemia, waldenstrom's macroglobulinemia. 
• 
Individuals previously treated for HCV with sustained viral response in whom reinfection 
is suspected (individuals who continue to engage in risk behaviors) 
• 
Accept to participate in the study by signing the informed consent form. 
5.4 
Exclusion criteria 
• 
Have or have had hepatitis C with a proven cure by viral load at 12 weeks after the end 
of treatment without risk behaviors for reinfection. 
• 
Be on antiviral treatment against chronic hepatitis C virus. 
• 
That the patient voluntarily and consciously refuses to sign the informed consent form or 
is unable to give it due to any type of physical and/or mental disability. 
5.5 
Variables  
Table 1. Study variables 
Category 
Variable name 
Conceptual 
definition 
Operational 
definition 
Measuring 
scale 
Sociodemographic 
ID Number 
ID Number 
Personal 
identification 
number 
under 
which you are 
registered in the 
country of origin 
Nominal 
Age 
Duration 
of 
an 
individual's 
existence 
measured in units 
of time. 
 
Number in years 
Continual 
 
Gender  
Categorizes 
the 
1. Female 
Nominal 

 
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Category 
Variable name 
Conceptual 
definition 
Operational 
definition 
Measuring 
scale 
individual 
according to her 
biological 
characteristics. 
0. Male 
2. Undetermined 
 
Nationality 
Country of birth 
Name of country 
 
Nominal 
Department 
of 
Residence 
A 
geographic 
place to which the 
municipality or city 
where the person 
usually 
resides 
belongs.  
Name 
of 
department 
Nominal 
Municipality 
of 
residence 
Geographic place 
municipality/city 
where the person 
usually resides. 
Name 
of 
municipality/city 
Nominal 
Health 
Service 
Provider 
Institution (IPS) 
Place where the 
screening 
was 
performed. 
1= 
Fundación 
cardioinfantil 
2= 
Fundación 
Santafé 
3= 
Clínica 
Colombia 
4= 
Hospital 
Universitario 
San Ignacio 
5= 
Fundación 
Valle de Lili 
6= 
Hospital 
Pablo 
Tobón 
Uribe 
7= 
Hospital 
Universitario 
Julio 
Méndez 
Barreneche 
E.S.E. 
Nominal, 
polytomous 
Affiliation regime 
Category 
of 
affiliation to the 
health system. 
0=Not insured 
1=Subsidized 
2=Contributory 
3=Special 
4=Exception 
Nominal, 
polytomous 
Entity 
Benefit 
plan 
administrator 
(EAPB) or Entity 
obliged 
to 
compensate 
(EOC) 
The 
entity 
in 
charge of health 
care coverage. 
Name of entity 
Nominal 
Risk Factors 
Transfusion 
of 
blood products 
Administration  
of 
hemocomponents 
before 1996. 
0. No 
1. Yes 
Nominal, 
dichotomous 

 
15 
 
Category 
Variable name 
Conceptual 
definition 
Operational 
definition 
Measuring 
scale 
The year in which 
you received the 
transfusion 
Date 
(year) 
in 
which 
you 
received 
the 
transfusion. 
The 
year 
in 
which 
you 
received 
the 
transfusion 
transfusion 
Continual 
Major surgery 
Surgical 
procedure 
performed in the 
operating 
room 
under general or 
regional sedation 
that may require 
post-procedural 
in-hospital 
monitoring. 
Abdominal 
laparotomy: 
0. no; 1 Yes 
 
Gynecologic 
surgery of any 
type: 
0. No; 1 Yes 
 
Orthopedic 
surgery of any 
type: 
0. No; 1 Yes 
 
Any surgery that 
required 
in-
hospital 
post-
procedure 
surveillance for 
more than 24 
hours: 0. 
0. No; 1 Yes 
Nominal, 
dichotomous 
Intravenous drug 
use 
Having consumed 
intravenous drugs 
at any time. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Inhaled 
or 
intranasal 
drug 
use 
Having consumed 
inhaled drugs at 
any time. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Men who have sex 
with men 
Man who has had 
sex with men. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Known hepatitis B 
virus infection 
Refer to have a 
diagnosis 
of 
hepatitis B virus. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Known 
HIV 
infection 
Refer 
to 
HIV 
diagnosis. 
0. No 
1. Yes 
Nominal, 
dichotomous 
People who have 
had tattoos, 
body 
piercings, 
scarification, etc. 
Presence 
of 
tattoos or piercing 
or scarification. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Population 
deprived of liberty 
or 
previously 
incarcerated 
persons 
Being or having 
been deprived of 
liberty 
in 
a 
penitentiary 
center. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Liver disorders or 
disease 
A 
person 
with 
abnormal 
liver 
0. No 
1. Yes 
Nominal, 
dichotomous 

 
16 
 
Category 
Variable name 
Conceptual 
definition 
Operational 
definition 
Measuring 
scale 
tests 
or 
liver 
disease. 
 
Occupational 
exposure 
Healthcare 
workers 
or 
members of public 
safety 
(e.g., 
correctional 
service officers or 
police) who have 
been in contact 
with blood at work 
through 
needlestick 
or 
sharps injuries. 
0. No 
1. Yes 
Nominal, 
dichotomous 
 
Hemodialysis 
A person who has 
undergone 
hemodialysis. 
0. No 
1. Yes 
Nominal, 
dichotomous 
Comorbidities 
potentially 
associated 
with 
HCV infection. 
Diabetes, 
Ischemic 
heart 
disease, 
Cryoglobulinemia, 
Chronic 
renal 
failure,  
Sjögren's 
syndrome, 
Hypothyroidism, 
Flat 
lichen, 
Rheumatoid 
arthritis,  
Non-Hodgkin's 
lymphoma,  
Acute 
lymphoblastic 
leukemia, 
Waldenstrom's 
macroglobulinemi
a, Chronic renal 
insufficiency, 
Sjögren's 
syndrome 
0. No 
1. Yes 
Nominal, 
dichotomous 
Missed opportunity 
Doctor visits 
Doctor visits in the 
last month 
How many? 
Continued 
Sample results 
HCV 
antibody 
screening test 
Report 
of 
HCV 
antibody 
test 
result. 
0. Non-reactive 
1. Reactive 
Nominal, 
dichotomous 
Viral load test 
Report the viral 
load 
result 
of 
those 
patients 
who 
presented 
reactive 
HCV 
antibodies. 
0. Non-reactive 
1. Reactive 
Nominal, 
dichotomous 

 
17 
 
Category 
Variable name 
Conceptual 
definition 
Operational 
definition 
Measuring 
scale 
Follow-up 
SIVIGILA Report 
The 
confirmed 
cases of HCV as a 
public 
health 
event are reported 
to the surveillance 
system 
utilizing 
form 340. 
0: Not reported 
1: If reported 
Nominal, 
dichotomous 
Follow-up 
of 
confirmed case 
Follow-up 
that 
each 
case 
confirmed in the 
study has access 
to consultation by 
a 
clinical 
specialist. 
0. No 
Why? 
1. Yes 
Nominal, 
dichotomous 
Monitoring patient 
access 
to 
treatment 
0. No 
Why? 
1. Yes 
Nominal, 
dichotomous 
5.6 
Sampling frame 
The sample frame is made up of all persons over 18 years of age who attended health 
service provider institutions (IPS) participating in the study in hospitalization, emergency, 
outpatient, and any other hospital care services. 
5.7 
Sample selection method 
Non-probabilistic convenience sampling will include all patients who meet the eligibility 
criteria. The inclusion of participants will be consecutive until the calculated sample size is 
completed.  
5.8 
Sample size 
Considering that the prevalence of HCV in the hospital population with risk factors is 
unknown, 50% will be considered, with a confidence level of 95%, an error of 5%, a design 
effect of 3, and a population served on average for the institutions included of 280,186 during 
2021, the minimum sample size required per institution is 1,151 and the maximum with a 
confidence level of 99.99% is 4,519 (Table 1). 
 
 

 
18 
 
Table 1. Sample size for frequency in a population  
Population size (for finite population correction factor or fcp)(N): 
280.186 
 
Hypothetical % frequency of the outcome factor in the population (p): 
 
50%+/-5  
Confidence limits as % of 100(absolute +/-%)(d): 
5% 
Design effect (for group surveys-EDFF): 
3 
 
 
Sample Size (n) for Various Confidence Levels  
Confidence Interval (%) 
Sample size 
95% 
1151 
80% 
493 
90% 
811 
97% 
1411 
99% 
1986 
99.90% 
3236 
99.99% 
4519 
Sample size n = [EDFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1) + p*(1-p)].   
 
Source: Results from OpenEpi, version 3, the SSPropor open-source calculator. 
5.9 
Sampling and data collection procedure 
Once approval for the present study has been obtained from the research ethics committee, 
the standardized data collection phase will begin. Search strategy through opportunity 
screening. For each person who meets the inclusion criteria and wishes to participate, 
informed consent will be requested and a data collection form will be filled out (Annex 1). 
These patients will undergo pre-test counseling, a presumptive rapid test for HCV, and if 
positive, contact information will be requested for post-test counseling and evaluation 
through teleconsultation by one of the principal investigating hepatologists who will guide 
them to access the confirmatory test for HCV, the study will assume the responsibility for its 
realization. Once the care pathway is established, the subsequent follow-up of the patient 
with a reactive hepatitis C antibody test will be done through their EAPB or EOC. 
The sample will be taken by trained personnel by capillary puncture of the thumb region of 
the fingers of the right hand, after asepsis and antisepsis, the rapid diagnostic test HCV Ab 
Plus Rapid test with INVIMA registration 2018RD-0002353-R1 will be used with operational 
characteristics that allow its performance at the point of care obtaining a result in 15 to 20 
minutes. This rapid test for antibodies against HCV may be replaced by another test with 
similar operational characteristics (sensitivity and specificity). The recommendations 
described by the test manufacturer should be followed. 

 
19 
 
Once the capillary blood sampling is performed, the used implements and the blood samples 
obtained will be discarded according to biosafety protocols and no additional studies will be 
performed with these samples. The spaces designed to dispose of the material used will be 
the guardian to dispose of sharps and items contaminated with blood in a red biohazard bag 
that will go to final disposal by the company in charge of this purpose in the institution where 
the sample collection is carried out. 
Cases with reactive hepatitis C antibody tests will be reported to the hepatologist, 
gastroenterologist, or infectologist linked to the institution and who acts as the leading 
physician of the strategy in each institution and to the epidemiology service or unit of the 
respective institution for follow-up and notification to the National Public Health Surveillance 
System - SIVIGILA.  
Performing hepatitis C viral load for cases with positive hepatitis C antibodies either through 
a reference laboratory (Colcan) with which ACH has established an agreement or by 
payment to the Clinical Laboratory of the Hospital. 
All the information obtained will be recorded and processed individually (case by case) 
through a digital information system with cloud backup in real-time using a Case Report 
Form (CRF), with the use of a tablet. The review and validation of the data capture will be 
performed weekly. The information will be guarded and encrypted for the exclusive use of 
the principal investigators belonging to the Colombian Association of Hepatology, periodic 
quarterly reports and a final report will be submitted to each of the participating institutions. 
The information will be anonymized for their use. Access to the information will be 
independent for each institution. 
5.10 Data Analysis Plan  
Descriptive analysis will be performed for all variables of interest proposed in this study. 
Descriptive statistics (frequencies and percentages) will be estimated. For continuous 
quantitative variables, measures of central tendency (mean and median) and measures of 
dispersion (variance, standard deviation) will be estimated. Possible relationships between 
sociodemographic variables, risk factors, and documentation of positive HCV antibodies will 
be explored, for which a bivariate analysis will be performed using X2 (chi-square) tests to 
explore the proposed associations. All analyses will be performed with Stata version 18. 

 
20 
 
5.11 Tools to be used 
A form will be used to collect demographic data and the variables to be studied (Annex 1).   
6 
Ethical considerations 
This protocol will be submitted for review and evaluation by the Research Ethics Committee 
in each of the participating institutions to obtain the respective approval for its execution.  
The study is by the provisions of Resolution 8430 of 1993 of the Colombian Ministry of 
Health, according to article 11 numeral b, is classified as minimal risk, given that data 
records were used through common procedures consisting of a sample collection (blood) by 
capillary puncture. In addition, the criterion of respect for the dignity and protection of the 
rights and welfare of the participants will prevail. 
Informed consent will be requested in written form to all participants, giving clear and easily 
understandable information about the objectives of the research. The consent will be 
explained and doubts about it will be resolved, and complete freedom will be given to 
withdraw consent at any time during the study, for the reasons that the subject considers 
(Annex 2). 
The study will be coordinated by health professionals and the sampling and data collection 
will be performed by trained nursing assistants. The confidentiality of the data collected will 
be guaranteed, the information obtained will not be used for purposes other than the current 
research process, and at the time of disclosure of the information, sensitive data or data that 
allow the identification of the participating individuals will not be published, the rules outlined 
in the law 1581 of 2012 on habeas data will be followed. 
None of the authors have conflicts of interest to declare.  
 
 

 
21 
 
7 
Expected results & impact 
Strengthening of the scientific community  
Expected Result/Outcome  
Indicator  
Beneficiary  
Screening 
adults 
with 
risk 
factors for hepatitis C 
The proportion of people 
diagnosed with hepatitis 
C 
Users affiliated 
with the 
SGSSS, 
benefit 
plan 
administrators, and health 
personnel. 
Linkage 
to 
treatment 
of 
confirmed positive cases for 
HCV infection in the hospitals 
included in the study. 
The proportion of people 
diagnosed with chronic 
hepatitis C who started 
treatment 
Users affiliated 
with the 
SGSSS, 
benefit 
plan 
administrators, and health 
personnel. 
 Social appropriation of knowledge  
Expected Result/Output  
Indicator  
Beneficiary  
Circulation 
of 
specialized
knowledge: 
Presentation 
of 
results 
in 
scientific 
events 
(national and international). 
Participation 
in
scientific 
events
presenting 
research
results. 
Medical-scientific community, 
decision 
makers, 
hospital 
institutions. 
Circulation 
of 
specialized 
knowledge: 
Presentation 
of 
results to stakeholders of the 
Colombian SSSSS. 
Participation in events
with 
different
stakeholders 
of 
the
USGS. 
Insurers and providers of the 
SGSSS, 
patients 
at 
the 
national level. 
  
Generation of new knowledge  
Expected Result/Output  
Indicator  
Beneficiary  
Research article submitted to a 
journal indexed in one of the 
bibliographic 
citation indexes 
such as ISI-Web of Knowledge 
(Science Citation Index (Raffone 
et al.) and Social Sciences
Citation 
Index 
[SSCI]) 
or 
SCOPUS, 
Publindex, 
Lilacs, 
BVS, Latindex, among others. 
Scientific 
articles
published. 
Medical-scientific community, 
decision 
makers, 
hospital 
institutions. 
 
Expected impacts from the use of results 

 
22 
 
Expected Impact 
Time (years) after 
completion of 
project* 1-4 years 
Verifiable 
indicator 
Assumptions 
Improved timeliness of 
detection of new cases of 
hepatitis C in the hospital 
setting. 
1-4 years 
Increase 
in 
incidence rate for 
hepatitis C 
Medical 
staff 
adhering 
to 
the 
screening 
and 
diagnostic algorithm 
- applicability of the 
algorithm in people 
with risk conditions 
and exposures. 
Improved time between 
confirmatory 
PCR 
diagnosis and initiation of 
treatment. 
1-4 years 
Increase 
in 
the 
number of persons 
diagnosed 
with 
chronic hepatitis C 
who 
initiated 
treatment 
Standardization 
of 
route 
that 
allows 
compliance with all 
stages 
for 
the 
diagnosis, 
treatment, 
and 
follow-up 
of 
the 
patient with CH. 
Successful completion of 
treatment 
1-4 years 
Increase 
in 
the 
proportion 
of 
patients with cure 
(sustained 
viral 
response) 
Timeliness of follow-
up, 
patient 
adherence 
to 
treatment regimen. 
Changes 
in 
chronic 
hepatitis C prevalence 
figures 
5-9 
Trend in the crude 
prevalence 
of 
chronic hepatitis C 
Timely detection and 
treatment cause a
decrease in the risk 
of transmission. 
Short (1-4), medium (5-9), long (10 or more)   
8 
Communication strategies 
Each institution will use its mechanisms for the dissemination of the project and participatory 
strategies that it determines appropriate according to the type of clinical research and its 
institutional policies after consultation with the Colombian Association of Hepatology. 
9 
Trajectory of the researchers participating in the research project  
Javier Enrique Hernández Blanco. Specialist in Internal Medicine, Gastroenterology and 
Digestive Endoscopy, Master in Liver Diseases and Clinical Epidemiology. University 
Research Professor, President of the Colombian Association of Hepatology (2021-2023). 
Active participant in the National Plan for the Elimination of Viral Hepatitis, national lecturer 
in Viral Hepatitis B and C, former advisor in public health for the Secretary of District Health 
of Santa Marta, extensive experience in screening activities of viral hepatitis in the 

 
23 
 
community, co-author Colciencias project - CALL 777: Prevalence and modeling of Hepatitis 
C Virus infection in Colombia. 
10 Schedule of activities  
The duration of the project will be 11 months. 
Activities 
Start date 
End Date 
Development of the final protocol, 
consent reports, and approval by 
the ethics committees of each 
institution. 
Month 1 
Month 2 
Training of nursing staff for data 
capture, sample collection, referral 
to treatment, and follow-up 
Month 3 
Month 3 
Recruitment 
of 
participants 
- 
Identification of at-risk populations 
to be screened - Screening tests - 
Entry of data collected 
Month 3 
Month 8 
Verification of the quality of the 
collected 
information 
- 
Data 
analysis 
Month 3 
Month 8 
Data analysis 
Month 7 
Month 9 
Presentation of a final report 
  Month 10 
  Month 10 
Writing and submission of article 
for publication 
  Month 11 
  Month 11 
11 Budget 
This project will be executed by the Colombian Association of Hepatology (ACH), and is an 
initiative of the ACH in response to its commitment to join efforts to achieve the World Health 
Organization's goal of eliminating viral hepatitis by 2030, and is financed with ACH 
resources, which in turn are obtained from the association's activities and resources 
obtained in calls for project funding. 
At the Hospital, the study is under the direction of the lead physician and hospital staff 
assigned to perform the rapid tests and paid for with project resources. The hospital will 
incur no additional costs for the conduct of the project beyond allowing the use of its physical 
area for patient recruitment and point-of-care rapid testing outside the clinical laboratory. 
The cost of performing viral loads will also be borne by the ACH, for which a contract has 
already been established with the COLCAN reference laboratory, but they could also be 

 
24 
 
performed in the laboratory of the same institution at the cost of the project at a rate of COP 
238,000 (USD 49,96) for each viral load if the institutional laboratory expresses interest in 
processing the viral load samples of the cases with positive antibodies and after signing an 
agreement. 
Leadership in the communication and management of project resources vis-à-vis healthcare 
institutions is provided by the ACH, its board of directors, and the acting president or 
designee, along with alignment with each participating project institution leader. 
ACH is the author of the project and will provide the resources for the execution of the 
project. The items covered in the execution of the study do not include the costs of treatment 
or any clinical management procedure (for example, visits to the doctor, or follow-up 
laboratories) since they are part of the usual treatment for hepatitis C virus infection and it 
is contemplated in the Colombian regulations that once the case of confirmed hepatitis C is 
notified to SIVIGILA (file 340), every quarter the High Cost Account downloads that 
information, includes the patient in the national cohort of high-cost diseases-Hepatitis C, 
establishes communication/audit with the Benefit Plan Management Company (EAPB) to 
which the patient belongs and guarantees their linkage to treatment, treatment against 
hepatitis C which is free, at no cost to the EAPB or out-of-pocket expense for the patient 
and which is acquired in annual purchases by the CAC since 2017 through the centralized 
purchasing mechanism from the Pan American Health Organization. 
 
 

 
25 
 
12 Annexes 
12.1 Annex 1. Data collection instrument  
Adult screening for hepatitis C and linkage to treatment in Colombian hospitals 
Patient's name: 
Identification number: 
Age (in years):  
Sex: Male:____ Female:___ 
Contact phone number: 
Residence address:  
Department of Residence: 
 
Municipality of residence: 
Affiliation scheme: 
0. Uninsured: ______ 
1. Subsidized: ______ 
2. Contributory: ______ 
3. Special: ______ 
4. Exception: ______ 
Institución prestadora de servicio de salud (IPS): 
Fundación cardioinfantil ________ 
Fundación Santafé _______ 
Clínica Colombia   _______    
Hospital Universitario San Ignacio _______ 
Fundación Valle de Lili _______ 
Hospital Pablo Tobón Uribe _____ 
Hospital Universitario Julio Méndez Barreneche 
E.S.E. _______ 
E-mail: ____________ Nationality:__________ 
Received blood transfusion before 1996: 
YES___ NO___ 
Year of transfusion: 
Name of EAPB or Entity obliged to 
compensate: 
Major Surgery: Yes___ No___  
  
Type of surgery: 
Abdominal laparotomy: Yes__ No__ 
Gynecologic surgery of any type: Yes__ No__ 
Orthopedic surgery of any type: Yes__ No__ 
Any surgery that has required post-procedure 
in-hospital surveillance: Yes__ No__  
Tattoos:  
Yes__ No__ 
Intravenous drug user:  
Yes__ No__   
Nasal drug user:  
Yes__ No__ 
Man who has sex with men: 
Yes__ No__ 
Known hepatitis B virus infection: 
Yes__ No__ 
Known HIV infection: 
Yes__ No__ 
Have you ever had tattoos or body piercings? 
Yes__ No__ 
Abnormal liver tests or with liver disease: Healthcare workers or members of public 

 
26 
 
Yes__ No__ 
safety (e.g., correctional service officers or 
police) who have come into contact with blood 
at work through needle sticks or sharps 
injuries: 
Yes__ No__ 
A 
person 
who 
has 
undergone 
hemodialysis: 
YES__ NO__   
Diagnosis of diabetes: 
YES__ NO__ 
Diagnosis of Cryoglobulinemia: 
YES__ NO__  
Diagnosis of coronary artery disease: 
YES__ NO__ 
Diagnosis of renal failure: 
YES__ NO__ 
Population deprived of liberty or previously incarcerated persons: YES _NO__ 
HCV antibody detection test: 
Non-reactive: _____ 
Reactive: _______ 
Viral load test: 
Positive: ______ 
Negative: _____ 
Not applicable: ______(in all cases where HCV antibody screening test is non-reactive). 
Case reported to Sivigila YES__ NO__ 
The positive case has been followed up YES _NO__ 
The patient has had access to a specialized consultation YES _NO__ Why? 
The patient was able to access treatment YES _NO__ Why? 
Date of completion: 
Name of the person doing the diligence: 
12.2 Annex 2. Information security for web applications in Hostinger with MySQL 
Information security is a critical priority in the development and operation of web, mobile, 
and desktop applications. This section aims to provide an overview of best practices and 
security measures implemented and best practices to be performed during project execution 
to protect sensitive information and ensure the availability and integrity of the application. 
I. Authentication and Authorization 
1. Application access password: Secure and complex passwords must be used. The use of 
combinations of upper- and lower-case letters, numbers, and special characters is 
recommended. The password will be assigned directly at the time of user creation.  
2. Two-factor authentication (2FA): Implement two-factor authentication to add a layer of 
security to application and database access. Two-factor authentication will work for access 

 
27 
 
to Hostinger, where the VPS server administration, MySql database, and web hosting 
configuration are located. 
3. Role-based authorization for Hostinger: Establish appropriate roles and permissions to 
ensure access to the dashboard and administration of the server, hosting, and database of 
the project. The administration will be in charge of Crecemos - Laboratorio de Estrategias 
Digitales SAS, a strategic ally for the digital management of the Association, working on 
management issues, updates, software patches, and product updates. Access and 
permissions to additional users will be requested and established by the Colombian 
Association of Hepatology. 
4. Role-based authorization for the application: Establish appropriate roles and permissions 
to ensure that users only have access to the parts of the application according to their 
responsibility. 
Three 
roles 
were 
defined 
with 
the 
following 
permissions: 
a. SUPER ADMINISTRATOR: Will have full access to the web application where he/she can 
manage users, full access to the dashboard and download information, quick test upload, 
and viral test upload. 
b. ADMINISTRATOR: Will have partial access to the web application where he/she will have 
access to the dashboard filtered by the medical institution to which he/she belongs and will 
be able to download the corresponding information, upload quick tests, and upload viral 
tests.  
c. OPERATIVE: Will have partial access to the web application where he/she will be able to 
access the dashboard filtered by the medical institution to which he/she belongs, upload the 
rapid test, and upload the viral test. 
5. Authorization and remote access to the database: Direct access to the database through 
some database viewer or terminal, you will have to access with user credentials, and 
password and have SSH authentication, which will be managed by Hostinger administrator 
staff. It is recommended not to access directly to the database in this way. 
II. Data Protection 
1. Data Encryption: HTTPS (SSL/TLS) implementation to encrypt the communication 
between the client and the server. Also, a proprietary API was implemented to channel 
communications with the database, and the storage of confidential information was 
configured especially for sensitive information: 

 
28 
 
a. Auto incremental and auto-generated ID for records in the database. 
b. Relation of the information employing IDSs specific to each record. 
c. Patient's ID only for linking rapid load test with viral load test. 
d. Confidentiality of the patient's name in the database storage. 
2. API Implementation: Development and implementation of a proprietary API Rest 
(backend) to channel and control direct communications with the database. The API has 
access to the database in secret and encrypted files inside the same server.  
Authentication and authorization middlewares were implemented for user access and a layer 
of DTOs (Data Transfer Object) was implemented to validate the information that the API 
receives and responds to the capture web application (client). The connection to the private 
API is made by the capture web application (client) using its encrypted keys. The 
communication protocols allowed by the API: 
a. GET: Get information, download information 
b. POST: Upload quick test form, upload viral upload form, and user creation. 
c. PUT Edit users 
d. DELETE: No delete commands are allowed. 
III. Updates and Patches 
1. Keep Software Updated: Keep the operating system, the web server, the MySQL 
database, and all libraries and frameworks used updated with the latest security patches. 
2. Audit Code: Perform regular security audits of application code to identify potential 
vulnerabilities and correct them promptly. 
IV. Attack Protection 
Firewalls and Security Filters: Configuration of firewalls and security filters to block malicious 
traffic and common attacks, such as brute force attacks and SQL injection. Hostinger 
features DDoS protection and a configurable firewall for SSH and HTTP protocols and port 
definition. 
Security Monitoring: Periodic security monitoring to detect unusual or potentially malicious 
activity and generate alerts. 

 
29 
 
V. Backup and Recovery 
1. Backups: Scheduling regular backups of the MySQL database and application files.  
Storage of these copies in secure locations. Full server backups perform automated 
snapshots every week and even the possibility of generating manual snapshots on demand 
or application updates. In case of any vulnerability or inconvenience, it is possible to revert 
to a previous version quickly.  
2. Business Continuity Plan: In case of any security incident, access vulnerability, or even 
server downtime, the following recovery and business continuity procedures are in place: 
a. Backups and copies of the databases in a server outside Hostinger.  
b. Repositories of the capture web application (Frontend) and the API (Backend) in Gitbuh 
for rapid deployment on a different server. 
c. No dependency on a specific server to be able to deploy and run the application again. 
d. Restoration of the latest database backup version. 
VI. Education and Awareness 
User and staff training: Educate Users Association staff and project participants from each 
medical institution about security practices, the importance of strong passwords, and how 
to recognize phishing attacks and other fraud attempts. 
VII. Legal Compliance 
Regulatory Compliance: Hostinger has data centers located in North America, Europe, Asia, 
and South America. Each server used for hosting web pages, web applications, and other 
services has encryption and information security certifications. Additionally, the 
aforementioned document is defined with the architecture and security protocols as 
requested in the acceptance criteria of the capture web application. 
Conclusion 
Information security is an ongoing and constantly evolving endeavor. This document 
provides a foundation for ensuring the security of a web application hosted by Hostinger with 
a MySQL database, but it is essential to continue to monitor and update security measures 
as the security threat evolves. 

 
30 
 
In addition to the measures mentioned above, it is recommended to perform regular 
penetration testing and collaborate with information security professionals to identify and 
address potential vulnerabilities. 
Information security is an ongoing commitment and a shared responsibility for everyone 
involved in the development, management, and operation of the web application. 
13 References 
1. 
Division of Viral Hepatitis, National Center for HIV VH, STD, and TB Prevention,. 
Viral Hepatitis: Hepatitis C Atlanta: Centers for Disease Control and Prevention (CDC); 2020 
[Available from: https://www.cdc.gov/hepatitis/hcv/. 
2. 
Organización Mundial de la Salud. Hepatitis C [Internet]. Ginebra, Suiza: OMS; 2022 
[07 
marzo 
de 
2023]. 
Available 
from: 
https://www.who.int/es/news-room/fact-
sheets/detail/hepatitis-c. 
3. 
World Health Organization. WHO publishes updated guidance on hepatitis C 
infection – with new recommendations on treatment of adolescents and children, simplified 
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https://www.who.int/news/item/24-06-2022-WHO-publishes-updated-guidance-on-
hepatitis-C-infection. 
4. 
World Health Organization. Global Health Sector Strategy on Viral hepatitis 2016-
2021. Towards  ending  viral  hepatitis. Geneva:  Switzerland: World Health Organization; 
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Dhiman RK, Premkumar M. Hepatitis C Virus Elimination by 2030: Conquering 
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Lazarus JV, Safreed-Harmon K, Thursz MR, Dillon JF, El-Sayed MH, Elsharkawy 
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1666841 
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Fondo Colombiano de Enfermedades de Alto Costo. Día mundial de la hepatitis 
2022. Bogotá D.C., Colombia: CAC; 2022 28 de julio de 2022. 
8. 
Instituto Nacional de Salud. Protocolo de Vigilancia de Hepatitis B, C y 
coinfección/superinfección 
Hepatitis 
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2022;Versión 
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CDA Foundation. Polaris Observatory: HCV Year of Archieving Elimination Targets. 
Online: CDAF; 2023. 
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de la hepatitis C en Colombia. Revista panamericana de salud publica = Pan American 

 
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Fondo Colombiano de Enfermedades de Alto Costo. Situación de la hepatitis C 
crónica en los regímenes subsidiado y contributivo de Colombia 2021. Bogotá D.C., 
Colombia: Cuenta de Alto Costo (CAC); 2022. 
12. 
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Hiebert L, Hecht R, Soe-Lin S, Mohamed R, Shabaruddin FH, Syed Mansor SM, et 
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the WHO 2030 Targets: Proposed Strategy, Coverage, and Costs. Value in Health Regional 
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Pawlotsky JM, Ramers CB, Dillon JF, Feld JJ, Lazarus JV. Simplification of Care for 
Chronic Hepatitis C Virus Infection. Semin Liver Dis. 2020;40(4):392-402. doi:10.1055/s-
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Fondo Colombiano de Enfermedades de Alto Costo. Informe de seguimiento de 
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Cuenta de Alto Costo (CAC); 2020. p. 31. 
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Hill AM, Nath S, Simmons B. The road to elimination of hepatitis C: analysis of cures 
versus new infections in 91 countries. Journal of virus eradication. 2017;3(3):117-23.  
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Ghany MG, Morgan TR. Hepatitis C Guidance 2019 Update: American Association 
for the Study of Liver Diseases-Infectious Diseases Society of America Recommendations 
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19. 
Tordrup D, Hutin Y, Stenberg K, Lauer JA, Hutton DW, Toy M, et al. Additional 
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