HepC Micro-elimination on MSM Comunity
Conditions: Hepatitis C, PrEP, Drugs of Abuse
Sponsor: Projecte dels NOMS Hispanosida

 
 
 
 
 
 
 
 
 
HCV micro-elimination in the MSM community  
 
 
 
Code: MSM-HCV-MicroElimination 
 
 
Version 3.0, 22-07-2021 
 
 
 
Sponsor:  
PROJECTE DELS NOMS-HISPANOSIDA 
Fundació FLS Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la 
Salut i la Ciència 
 
 
 
 
 
Principal investigator: Roger Paredes, MD, PhD 
 
 
 
 
 
 
 
Co-Investigators:  
 
• 
Angel Rivero Calaf 
• 
Josep Maria Llibre Codina 
• 
Pep Coll Verd 
• 
Michael Meulbroek 
• 
Jorge Saz Berges 
• 
Ferran Pujol i Roca 
• 
Felix Perez Tejera  
 
 
 
 
 
 
 
 
 
 
 
 
 
The information contained in this document is confidential and must not be revealed to third persons 
without prior authorization as contemplated by Law. 

 
 
 
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1. SUMMARY 
1.1. Sponsor identification and Address 
 
Projecte dels Noms Hispanosida 
 
Adress: 
BCN Checkpoint 
C/comte Borrell 164-166 Baixos 
08015 Barcelona 
 
Fundació FLS Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la 
Salut i la Ciència 
 
Adress:  
Germans Trias i Pujol Hospital 
Carretera de Canyet s/n 
08916 Badalona (Barcelona) 
1.2. Title of the study 
 
HCV micro-elimination in the MSM community  
 
1.3. Code of the protocol  
MSM-HCV-MicroElimination 
1.4. Principal investigator and address 
Roger Paredes, MD, PhD 
 
Fundació FLS Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut 
i la Ciència 
 
Germans Trias i Pujol Hospital 
Carretera de Canyet s/n 
08916 Badalona (Barcelona) 
 
1.5. Type of sites where the study will be performed 
BCN Checkpoint 
C/comte Borrell 164-166 Baixos 
08015 Barcelona 
 
BCN PrEP-Point 
C/comte Borrell 168 Baixos 
08015 Barcelona 
 
1.6. Ethics Committee assessing the protocol 
CEIC Germans Trias i Pujol University Hospital  
Hospital Universitari Germans Trias i Pujol 
Carretera de Canyet s/n 
08916 Badalona (Barcelona) 

 
 
 
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1.7. Primary objective 
Determine the prevalence of acute and chronic HCV infection in HIV-uninfected 
MSM and TGW community. Serologic prevalence will also be determined.  
Stablish a fast-track circuit between Sexual Health Community centers and Hospital 
liver/infection diseases units to offer the possibility of starting treatment quickly 
after diagnosis and confirmation of HCV viremia on same day. 
1.8. Design 
Observational study 
1.9. Study pathology 
Hepatitis C virus (HCV) infection  
1.10. Type of population and number subjects 
 
Men who have sex with other men or transgender women, that are HIV negative 
and comes to get tested in our center or are under controls in our center. 
  
Estimated enrollment first Phase 6000-7000 participants. Second phase 2000-3000 
participants.  
 
1.11. Calendar 
• 
Ethics Committee application: June 2021 
• 
Study starts (first patient in): June 2021 
• 
Recruitment period: 2 years and 2 months. 
• 
Patient follow-up: Single visit. Screening. In case of positive HCV viremia, 6 
and 12 months post treatment control will be offered.  
• 
Final report:  2023. Reinfections will be reported during 2024. 
1.13 Financing source 
• 
Gilead Sciences 
• 
Cepheid 

 
 
 
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2. TABLE OF CONTENTS 
1. SUMMARY ................................................................................................ 2 
1.1. Sponsor identification and Address ........................................................ 2 
1.2. Title of the study ................................................................................. 2 
1.3. Code of the protocol ............................................................................ 2 
1.4. Principal investigator and address .......................................................... 2 
1.5. Type of sites where the study will be performed ...................................... 2 
1.6. Ethics Committee assessing the protocol ................................................ 2 
1.7. Primary objective ................................................................................ 3 
1.8. Design ............................................................................................... 3 
1.9. Study pathology .................................................................................. 3 
1.10. Type of population and number subjects ............................................... 3 
1.11. Calendar .......................................................................................... 3 
1.13 Financing source ................................................................................ 3 
2. TABLE OF CONTENTS ................................................................................ 4 
3. GENERAL INFORMATION ............................................................................ 5 
3.1. Code ................................................................................................. 5 
3.2. Title .................................................................................................. 5 
3.3. Sponsor information ............................................................................ 5 
3.4. Investigator and collaborators data ........................................................ 5 
3.5. Provisional sites and regions ................................................................. 5 
3.6. Expected study duration ....................................................................... 5 
4. RATIONALE .............................................................................................. 6 
5. OBJECTIVES ............................................................................................ 7 
5.1. Hypothesis ......................................................................................... 7 
5.2. Objectives .......................................................................................... 7 
6. INFORMATION SOURCE AND FIELD ............................................................. 8 
7. STUDY DESIGN ........................................................................................ 9 
7.1. Study population: Selection criteria ....................................................... 9 
7.2. Study Schedule of Assessments ............................................................ 9 
7.3. Sample size predetermination ............................................................. 12 
8. VARIABLES AND MEASURE INSTRUMENTS. ................................................ 13 
8.1. Study Variables ................................................................................. 13 
8.2. Endpoints ......................................................................................... 13 
9. STATISTICAL ANALISIS ........................................................................... 13 
10. ETHICAL ASPECTS ................................................................................ 14 
10.1. Benefit/Risk evaluation ..................................................................... 14 
10.2. Patient information and informed consent ........................................... 14 
10.3. Confidentiality ................................................................................. 15 
11. PRACTICAL CONSIDERATIONS ................................................................ 15 
11.1. Study plan ...................................................................................... 15 
11.2. Follow-up and final reports ............................................................... 16 
11.3. Results diffusion .............................................................................. 16 
11.4. Risks and potential limitations ........................................................... 16 
11.5. Expected Outcome ........................................................................... 17 
Appendix 1. Informed Consent ..................................................................... 18 
Appendix 2. Sexual behaviors and demographics questionnaire ......................... 18 
Appendix 3. Satisfaction questionnaire PROMs  (SUCE Adaptation) .................... 19 

 
 
 
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3. GENERAL INFORMATION 
3.1. Code 
MSM-HCV-MicroElimination 
3.2. Title 
HCV micro-elimination in the MSM community  
3.3. Sponsor information 
 
• 
PROJECTE DELS NOMS HISPANOSIDA 
 
• 
Fundació FLS Lluita contra la Sida, les Malalties Infeccioses i la Promoció de 
la Salut i la Ciència 
3.4. Investigator and collaborators data  
Investigators from BCN-Checkpoint and Infectious Diseases Service from the 
Hospital Germans Trias i Pujol. 
3.5. Provisional sites and regions  
BCN Checkpoint  
BCN PrEP-Point 
3.6. Expected study duration 
The duration of this study is planned to be 2 years June 2021 to July 2023.  
 
Following see the expected study calendar: 
• 
Ethics Committee application: June 2021 
• 
Study start (first patient in): June 2021 
• 
Recruitment period: 2 years and 2 months 
• 
Patient follow-up: Single visit on Screening. In case of positive HCV viremia, 
6 and 12 months post treatment control will be offered.  
• 
Final report: End of 2023. Reinfections will be reported during 2024.  

 
 
 
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4. RATIONALE  
 
Background and Significance 
 
Since 2000, there have been multiple reports of outbreaks of sexually transmitted 
acute hepatitis C virus (HCV) infection in HIV-positive men who have sex with men 
(HIV+ MSM) in urban areas of North America, Europe, Australia and Asiai. Acute 
HCV infection is more likely to become persistent in the presence of HIV, and liver 
fibrosis progression in chronic HCV infection is faster even in patients with 
undetectable HIV viral loadsii. At 2018 CROI meeting in Boston the Swiss HCVree 
trial suggested that offering HCV treatment to all diagnosed HIV/HCV coinfected 
individuals within the Swiss HIV Cohort may be successful in reducing new incident 
infections by almost 50% as well as reducing the burden of chronic HCV by over 
90%iii. Similar results had been reported at 2017 CROI in Seattle where again an 
increased uptake of DAA therapy in Netherlands with over 75% of all HIV/HCV 
coinfected MSM being cured caused a reduction in new infections by around 50% iv 
v vi. Thereby, these studies indicate that HCV micro-elimination may be achievable 
in well-identified patient populations. However, the challenge to overcome is the 
high risk of reinfection in a small number of subjects with very high-risk sexual 
practices, among HIV coinfected MSM, with reinfection rates of almost 25% after 
two years of follow-up after a first resolved or successfully treated episode of acute 
HCVvii. 
A potential source for HCV transmission may also come increasingly from HIV-
negative MSM. Various studies presented at CROI 2018 looked at HCV prevalence 
and incident infections in HIV-negative MSM entering PrEP studies showing that the 
acute HCV epidemic has now also reached the HIV-negative MSM populationviii ix, x. 
Clearly, early treatment of acute HCV will become crucial for achieving micro-
elimination to limit transmission possibilities. Data from the NEAT-ID foundation 
PROBE-C cohort looked at the natural course of acute HCV infection in HIV-
coinfected individualsxi, and only 11% of all patients were able to clear HCV 
infection spontaneously, which implies that an overwhelming portion of patients will 
go on to develop chronic HCV infection and require treatment. Early intervention 
appears advisable to prevent further onward transmission of HCV. However, there 
is a huge gap as for data and awareness in this population.  
 
 

 
 
 
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5. OBJECTIVES  
5.1. Hypothesis 
A community center for MSM and TGW, with a longstanding experience of early HIV 
detection, linkage to care and treatment initiation, might be able to create a model 
with low barrier for Point-of-Care (POC) HCV detection in an understudied 
population. Through a simple algorithm to achieve detection, confirmation, and 
treatment initiation at the same day, it would be able to achieve rapid HCV viremia 
suppression in this scenario. Moreover, this model will be replicable in other 
European cities, where similar community centers and POC technology are in place.  
5.2. Objectives 
The primary Goal of this project is to identify HCV acute and chronic infections in 
HIV-uninfected MSM and TGW community and to offer them a low barrier linkage to 
care in the context of a fast-track circuit, offering a first visit with a specialist and 
starting hep C treatment in the same day after confirmation. A total of 10-15 
unknown HCV infections are expected to be diagnosed during the study and to be 
treated. Potential risk factors for increased HCV infection rates include recreational 
drug use, including “chemsex”, PrEP use, sex work, and several sexual behaviors. 
We will analyze which factors entangle an increased infection risk. This will allow us 
to focus and intensify screening on people with these factors while reducing the 
costs of continuous HCV screening in people who maintain at high risk.  
 
Primary objectives 
• 
Determine the prevalence of acute and chronic HCV infection in HIV-
uninfected MSM and TGW community. Serologic prevalence will also be 
determined.  
• 
Stablish a fast-track circuit between Sexual Health Community centers and 
Hospital liver/infection diseases units to offer the possibility of starting 
treatment quickly after diagnosis and confirmation of HCV viremia on same 
day. 
 
Secondary objectives 
• 
Characterization of risk factors associated with acute and chronic HCV 
infection in the MSM and TGW community to inform which individuals will 
benefit more from HCV screening.  
• 
Creation of and HCV pre-test Score during Phase 1 and validation during 
Phase 2.  
• 
Evaluate user’s satisfaction with HCV testing using Patient Reported 
Outcome Measures (PROMs).  
• 
Evaluation of causes for treatment delay and/or loss to follow up.  
• 
Evaluation of reinfections after treatment during first year post treatment.  

 
 
 
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6. INFORMATION SOURCE AND FIELD  
Source documents are the patient's medical records. 
 
Study data will be collected through integrated forms in Salus (QSOFT, Software 
Salus 2017) that is software to compile user’s information used in sites participating 
in this study. It is allocated in a Secure Server according to Personal Data 
protection Laws.  
 
During the screening visit, the investigator will provide the participant the informed 
consent and will let the necessary time to read and understand the study 
procedures. If the participant agrees to participate in the study, he will sign the 
consent. One copy of the signed IC will be facilitate to the participant.  
 
 
 
A demographics and a sexual behavior questionnaire will be requested to be 
completed by the study participants at the screening visit (See Appendix 2).  
Additionally, at the end of each study visit, PROMs questionnaire to evaluate 
satisfaction will be carried out (See appendix 3)(In this study and adaptation of 
SUCE questionnaire will be performedxii). 
 
Additionally, and in case to be necessary  it will be asked to the participant 
information related to previous HCV infections or in case of a diagnostic to follow 
treatment received and results of blood test performed on other public health units 
of Catalonia.  
 
The study visits will be performed in the clinical installations of BCN CheckPoint or 
BCN PrEP·Point, allocated in Barcelona C/ Comte Borrell 164-166 and 168 
respectively.  
 
Laboratory determinations 
 
Point of care test (POCT) will be performed in BCN Checkpoint and BCN PrEP·Point. 
 
Whole blood antibodies will be tested with POCT using immunochromatographic 
rapid test (Abbott rapid HCV test “SD BIOLINE HCV assay”). Viral load to screen 
and confirm will be performed with whole blood by Point of Care Real-Time 
Quantitative Reverse Transcription PCR (Cepheid “Xpert® HCV VL Fingerstick”), 
genotypes 1-6 are covered by this technique, and its limit of detection is 35 IU/mL.  
 
Acute infections with negative antibodies will be also tested with (Cepheid “Xpert® 
HCV Viral Load), genotypes 1-6 are covered by this technique and its limit of 
detection is 4.0 IU/mL in plasma and 6.1 IU/mL in genotype 1. 
 
Chemistry and Microbiology HUGTiP laboratories will be used for genotype study 
and hematology and chemistry evaluation in case of a confirmed diagnostic 
(positive viral load). Exam will include blood count (3mL EDTA tube), Serum 
Creatinine, AST, ALT, GGT, alkaline phosphatases, direct and indirect Bilirubin (5mL 
SST gel Tube), Prothrombin Time (2.7mL coagulation tube) and for the HCV 
Genotype (10 mL EDTA tube). A total of 20.7mL will be obtained per venipuncture 
 
Microbiology HUGTiP laboratories will be also used for the cases that positive 
serology is obtained with rapid test and viral load is negative, without having 
received previous treatment for HCV or without previously known infection, to 

 
 
 
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confirm possible cases of spontaneous Cure. In these cases, a total of 7mL (SST gel 
tube) will be obtained by venipuncture. 
7. STUDY DESIGN 
7.1. Study population: Selection criteria  
 
Inclusion Criteria 
 
1. All BCN Checkpoint and BCN PreP·Point clients.  
2. 18 years and older.  
3. HIV uninfected or diagnosticated in the center in the last 7 days prior to the 
study inclusion.  
4. Men that have sex with men or transgender women. 
5. Signature of written consent form.  
6. Ability to comply with the requirements of the study protocol.  
 
Exclusion Criteria 
 
1. Knowledge of HIV infection from more than 7 days 
2. Knowledge of active HCV infection  
7.2. Study Schedule of Assessments 
 
This project will be performed in the BCN Checkpoint and BCN Prep·Point , which is 
a community center for sexual health care and detection of HIV and other STIs for 
MSM and TGW since 2006.  
 
The services offered by both centers are focused on prevention through early/acute 
detection of HIV plus fast access to treatment, promotion of biomedical approaches, 
as well as the promotion of a healthy sexuality among the MSM community.  
 
The center also has experience in systematic detection of asymptomatic STIs and 
their treatment to prevent their dissemination among the community and the 
general population. Fast linkage to care has been established in collaboration with 
“Fundació Lluita contra la Sida” and with the “Hospital Universitari Germans Trias i 
Pujol”, wherein during 2019 a total of 7.581 persons were attended.  
 
This study will have two different phases: phase 1 (first year) and phase 2 (second 
year). 
 
All the participants should answer the “Sexual Behavior and demographics” 
questionnaire (Appendix 2), before any blood study extraction during phase 1 and 
phase 2.  
 
Phase 1:  
 
 
1A. Assess the prevalence of untreated HCV infection among HIV-negative MSM 
and TGW.  
 
During the first year all clients of BCN Checkpoint (6,000-7,000) will be offered a 
serology test, Abbott rapid HCV test “SD BIOLINE HCV assay”. It will take 5 
minutes to obtain the test results.  

 
 
 
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If a positive result is obtained in serology test a Cepheid “Xpert® HCV VL 
Fingerstick” will be performed to identify HCV Viremic cases. The time to obtain the 
test result will be 60 min approximately.  
 
In case of positive serology and positive viral load, Chemistry and Microbiology 
HUGTiP laboratories will be used for genotype study and hematology and 
chemistry. 
 
In case of positive serology with negative viral load, standard lab serology will be 
also performed to confirm serology, thrown standard hospital lab circuit. If 
confirmation, this participant will be considered as previously HCV infection with 
spontaneous cure, if no treatment has been received previously (See table 1). 
 
All participants diagnosticated with viremic HCV infection will be offered a 6 and 12 
month post treatment visit to asses possible reinfections. Cepheid “Xpert® HCV VL 
Fingerstick” will be used as described before to evaluate reinfections. Theses visits 
will remain without changes during all phases of this study. 
1B. Also, during the first year, 1.000 subjects with a previous negative “SD 
BIOLINE HCV assay” will be offered Cepheid “Xpert® HCV VL Fingerstick” tests to 
detect acute HCV infection if they fulfil at least one of the following criteria
xviii
xxiii
xiii, xiv, xv, 
xvi, xvii, 
, xix, xx,xxi, xxii, 
, xxiv:  
 
1. 
Group sex with ChemSex use during last 3 months. 
2. 
Slamming during last 3 months. 
3. 
Fisting without gloves during last 3 months. 
4. 
Sharing anal play toys without condoms during last 3 months. 
5. 
Sharing sniffing roller for cocaine or other drugs during last 3 months.  
6. 
Partner with active HCV or recently diagnosed with HCV on the last 3 
months 
7. 
PrEP use*  
8. 
Previous HCV Infection,  
9. 
HIV infection recently diagnosticated. 
 
*PrEP alone as unique criteria will not be considered condition to perform HCV viral 
load, if it is the only condition, as in our center PrEP users are screened before starting 
PrEP and each year with serologic screening. Also, HCV screening is performed in case 
of founding high liver enzymes levels in periodic blood tests performed in PrEP routine 
controls.  
 
The participants with a previous negative “SD BIOLINE HCV assay” and a positive 
“Xpert® HCV VL Fingerstick” will be confirmed with the Cepheid “Xpert® HCV Viral 
Load”. In these cases, a standard lab serology, hematology and biochemical exam 
will be also performed thrown standard hospital lab circuit (See table 1). 
  
 
 
 
 
 

 
 
 
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Table 1. Study Chronogram Phase 1 
 
 
 
 
 
 
 
 
 
 
a) 
The participants that obtain a positive result from the SD Bioline HCV assay test will be confirmed with Cepheid “Xpert® 
HCV VL Fingerstick” to identify HCV viremic cases. Also first 1000 participants with a negative result from the SD Bioline 
HCV assay test that fulfils criteria mentioned on 1B point, will be confirmed with Cepheid “Xpert® HCV VL Fingerstick” 
to identify acute HCV infections. *During V6MPTV and V12MPTM the fingerstick will be offered to all the participants 
with HCV infection detected during the screening visit.  
 
b) 
Acute infections with negative antibodies will be also tested with (Cepheid “Xpert® HCV Viral Load) to confirm viremic 
cases.  
 
c) 
In case of positive serology with negative viral load, standard lab serology will be performed to confirm serology, 
thrown standard hospital lab circuit.  
 
d) 
For the confirmed HCV Viremic cases,  it will be analyzed the following parameters: blood count, Serum Creatinine, AST, 
ALT, GGT, alkaline phosphatases, direct and indirect Bilirubin, protrombine time and the genotype study will be 
performed.  
 
* Visits after 6 months and 12 months are optional and only are applicable for those patients that had been 
diagnosticated and treated for HCV infection during the screening visit. 
 
After one year, a statistical analysis (interim analysis at 6 months*) of the results 
will be made to determine associated factors for positive antibody test as well as for 
positive acute HCV test to set selection criteria for phase 2 of the study. A Draft of 
HCV pre-test Score will be developed with this first-year analysis and implemented 
during second phase.  
 
*Interim analysis will be used to evaluate data collection, correct incidences and to 
set up data analysis system. This will facilitate the results evaluation at the end of 
Phase 1 and it will allow to create the pre-test score to start the study Phase 2. 
 
Phase 2: Targeted testing 
 
During the second year, selected criteria from pre-test score will be used to offer 
clients an HCV rapid antibody test “SD BIOLINE HCV assay”. Estimation of tests: 
2,000-3,000. Depending on the results obtained on the first year, this analysis 
could change.  
 
SCREENING 
6 months Post 
Treatment visit 
* 
12 months Post 
Treatment visit* 
Informed consent 
X 
 
 
Selection Criteria 
X 
SD BIOLINE HCV assay 
X 
Cepheid “Xpert® HCV VL 
Fingerstick”  
X
a
 
X
a
 
X
a
 
Xpert® HCV Viral Load 
X
b
 
Routine Serology 
X
c
 
 
 
genotype study/Hematology and 
biochemical analysis 
X
d
 
Sexual behavior & demographics 
questionnaire 
X 
PROMS questionnaire  
X 
X 
X 
 

 
 
 
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In addition, about 300 participants that complies the SCORE criteria founded during 
phase 1 for acute HCV infection, will be performed Cepheid “Xpert® HCV VL 
Fingerstick”. On Visits V6MPT and V12MPT, screening will be performed with 
Cepheid “Xpert® HCV VL Fingerstick”. 
 
The goal with both detection strategies is to uncover a 3-time higher prevalence 
rate, according to our experience with HIV criteria obtained after evaluation of 
factors.  
 
Procedures in case of positive results will be as described on first year phase. Final 
report will focus on proposing how the model could be replicated in other similar 
cities and settings.   
 
Table 2. Study Chronogram Phase 2 
 
SCREENING 
6 months visit * 
12 months visit* 
Informed consent 
X 
Selection Criteria ** 
X 
SD BIOLINE HCV assay 
X 
Cepheid “Xpert® HCV VL 
Fingerstick” 
Xa 
Xa 
Xa 
Xpert® HCV Viral Load 
Xb 
Serology 
Xc 
genotype 
study/Hematology and 
biochemical analysis 
Xd 
Sexual behavior & 
demographics 
questionnaire 
X 
PROMS questionnaire 
X 
X 
X 
 
a) 
About 300 participants that complies the SCORE criteria founded during phase 1 for acute HCV infection, will be 
performed Cepheid “Xpert® HCV VL Fingerstick”. On Visits V6MPT and V12MPT, screening will be performed with 
Cepheid “Xpert® HCV VL Fingerstick”. 
 
b) 
If the Xpert® HCV VL Fingerstick test is positive, and SD BIOLINE HCV assay is negative , a confirmation viral load test will 
be performed to the participant “Cepheid “Xpert® HCV Viral Load” 
 
c) 
In case of positive serology with negative viral load, standard lab serology will be performed to confirm serology, 
thrown standard hospital lab circuit. 
 
e) 
For the confirmed HCV Viremic cases,  it will be analyzed the following parameters: blood count, Serum Creatinine, AST, 
ALT, GGT, alkaline phosphatases, direct and indirect Bilirubin, protrombine time and the genotype study will be 
performed.  
 
* Visits after 6 months and 12 months are optional and only are applicable for those patients that had been 
diagnosticated and treated for HCV infection during the screening visit. 
 
** The selection criteria will be defined according to the pre-test score finded during phase 1.  
7.3. Sample size predetermination  
 
This observational study will include up to 7000 participants during Phase 1 and up 
to 3000 participants during Phase 2. Size determination has been determined by 
expected users during the first year to participate in the cohort. It will not be 
possible to determine a necessary size to optimize this study as there are no data 
concerning HCV prevalence in HIV-uninfected MSM and TGW in our allocation.  
 

 
 
 
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8. VARIABLES AND MEASURE INSTRUMENTS.  
8.1. Study Variables 
 
• 
Determination of acute HCV cases detected by viral load. 
• 
Number of positive viremic results and cases per 100 person-years. 
• 
HCV serologic prevalence.  
• 
Number of positive serologic test with or without positive viremia.  
• 
Time between confirmed diagnostic and start of treatment (Measured in 
days). 
• 
Number of reinfections at 6 and 12 months after treatment. 
• 
Identification of risk factors using the sexual behavior and demographics 
questionnaire 
• 
Ratio of satisfaction using “Patient Reported Outcome Measures” (PROMs) 
• 
Causes of treatment delay or loss to follow up 
• 
Reinfections/treatments measured in percentage. 
8.2. Endpoints  
Primary End-points 
• 
Proportion of viremic HCV prevalence in MSM and TGW community in 
Barcelona at the screening visit.  
• 
Determination of acute cases detected by Viral load during screening visit 
• 
HCV Seroprevalence with non-viremic status at screening visit.  
• 
Number of days between diagnosis and treatment initiation during the study.  
 
Secondary End-points 
• 
Characterization of risk factors associated with acute and chronic HCV 
infection in the MSM and TGW community to inform which individuals will 
benefit more from HCV screening. 
• 
Evaluation of causes for treatment delay and/or loss to follow up a long the 
study  
• 
Evaluation of reinfections after treatment during first year post treatment.  
• 
Service user’s punctuations achieved after experience in HCV testing.  
9. STATISTICAL ANALISIS  
A descriptive analysis will be conducted for the following variables: number of 
subjects, sociodemographic characteristics (gender, age, and partner’s HCV status), 
sexual behavioral patterns (number of partners, drug use while having sex), PrEP 
use, and biological results. Results are presented in terms of incidence rate ratios 
(IRRs) and 95% confidence intervals (CIs) and their p-values of active HCV 
infections and presented as cases per 100 person-years. Depending on the type or 
distribution of each variable, absolute frequencies (N) and percentages (%), 
interquartile range (Q1– Q3), or standard deviation (SD) will be calculated. This 
descriptive analysis will be presented calculated for individuals separately to allow 
investigation of the association between groups. Categorical variables will be 
evaluated by Chi square test or Fisher’s test, while Student’s t-test or Wilcoxon test 
was used for continuous variables.  After the first phase we will conduct a 
univariate analysis with all independent factors (HCV risk factors). The outcome 
variable will be the number of new cases of HCV and taking into account the 
population at risk. Factors associated with HCV infections with univariate p-
value<0.1 will be entered in Poisson regression, adjusted by age and gender. A 

 
 
 
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significant level of 5% will be taken into account for all analysis performed. 
Descriptive statistics of demographic factors, and sexual behavior patterns and 
biological results will also be carried out for possible reinfections detected during 
follow up visits. A descriptive analysis of the patient reported outcomes will also be 
carried out and presented in the final report. All analyses will be carried out by 
means of the STATA 14.2 (StataCorp LP, College Station, TX USA).  
10. ETHICAL ASPECTS  
This study will be carried out following the ethical principles recovered in the 
Declaration of Helsinki from Brazil, October 2013. 
This study will be conducted according to Spanish regulations regarding biomedical 
investigations (Organic Law 14/2007 of biomedical investigation) 
 
The required documentation prior to the start will be:  
 
• Protocol approval by the Ethics Committee.  
 
Confidentiality requirements will follow the required Data Protection legislation (see 
section 10.3). 
10.1. Benefit/Risk evaluation 
Participating in this study offers the option of being screened against Hepatitis C 
Virus, in the context of a full Screening of other STI that are not the objective of 
this study. Complete assessment and information about transmission ways and 
possible ways of protection will be offered during the visit.  
 
Participating in this study has not significant risks. Only those associated to 
capillary blood sampling that can implicate little bleeding or pain in the puncture 
area.    
 
10.2. Patient information and informed consent   
 
The investigator will inform the candidates of the nature, duration, and purpose of 
this study and, in addition, of all the inconveniences and obstacles that, if any, can 
be expected. In addition, written information will be provided to the patient. 
Patients must have the legal capacity to give their consent and exercise their 
freedom of decision. Written informed consent will be obtained by signing the study 
informed consent form. 
 
One copy of the signed IC will be facilitate to the participant. 
 
 
 
 
The consent forms will be reviewed whenever there were changes in the study 
procedures or new information were available that may affect the patient’s 
willingness to participate. Patients will reconfirm consent with the most recent 
version of the consent forms during their participation in the study, and the process 
will be recorded in the medical record by the investigator. 
 
All signed and dated consent forms must remain in the investigator site file and 
must be available for verification at any time.  

 
 
 
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10.3. Confidentiality 
The processing of the data will be performed in accordance with Spanish Organic 
Law 3/2018 (LOPD-GDD), which develops the General Data Protection Regulation 
2016/679 on data protection and privacy for all individuals within the European 
Union (GDPR). The individuals and donors will be guaranteed anonymity, and at the 
time of informed consent signature were informed that all communication shall take 
place between him/her and the investigator of the study they participated in. This 
study will be conducted using pseudonymized data. The patient will be identified in 
the records by the corresponding unique code number, not associated with any of 
his/her personal data. The database used for this study, is SALUS (Microsoft® SQL 
Server).  
 
In order to prevent improper access by unauthorized third parties, security 
measures will be implemented such as the pseudonymisation of the data, the 
control of access to the database SALUS (Microsoft® SQL Server) through secure 
personal passwords and its storage on a secure server located in the European 
union under current regulations with the highest quality and specific security and, if 
necessary, encrypted data transfer.  
 
 
The data controller will be the co-sponsors of this project:  
 
- 
La Fundación FLS de Lucha contra el Sida y las enfermedades infecciosas, 
(lopd@flsida.org) 
 
- 
PROJECTE DELS NOMS-HISPANOSIDA,  info@hispanosida.com      
 
- 
In addition, the data controller of the data that will be integrated in the 
participant’s Medical History will be the Institut Català de la Salut, 
dpd@ticssalutsocial.cat.  
 
 
Data transmitted to third countries, and other countries, will in no case contain 
personal data. If such transfer occurs, it will be for the same purposes of the study 
described and ensuring confidentiality, at least to the level of protection of the law 
in Spain.  
 
 
11. PRACTICAL CONSIDERATIONS 
11.1. Study plan 
June 2021-May 2022 Phase 1 
 
June-July 2021 Phase 1 data Analysis and Pre-Test Score development.  
 
August 2022-July 2023 Phase 2 
 
August 2023- January 2024 Phase 2 analysis and results reporting 
 
February 2023-September 2024 6 and 12 months post treatment visits.  
 

 
 
 
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October 2024-November 2024- Reinfections reporting 
 
11.2. Follow-up and final reports 
It’s planned an interim analysis report at 6 and 12 months after the study initiation.   
 
A final report will be performed with the obtained results.  
 
11.3. Results diffusion  
It is planned to communicate this study in national and international conferences of 
socio-sanitary interest and one or many English publications (peer review). 
 
11.4. Risks and potential limitations 
As this project will be included in an ongoing project of community screening, 
recruitment is not expected to be a problem, however intensification of campaigns 
for promotion of HCV testing will be considered in case of lack of interest in our 
actual users. 
 
Questions related to risk factors such as number of sexual contacts, drug use, etc.  
will be asked by the counselor and could produce an underestimation of these risk 
factors. However, we have been working with this kind of questionnaires for the last 
15 years and users have never expressed any problem due to a peer-to-peer 
service, which allows a safe environment for the clients. All our staff and volunteers 
are previously selected and adequately trained.  
 
Users with positive results could refuse to attend the medical specialist in the 
Hospital Germans Trias due to the distance. In this case derivation to other Hospital 
could be considered. However, treatment will last only 8-12 weeks and usually 
require no subsequent follow-up. So, in our opinion the interference of this problem 
in this study would be extremely limited, other Hospitals on the city are working in 
Test and Treat HCV strategy and referral has been done in the past; also, we will 
ask for follow up with the participant through telephone calls. 
 
The Partner notification potential Contacts will be performed in our center in 
collaboration with the Public Health agency to offer testing to positive case 
contacts. However, in the MSM community this can sometimes be difficult or even 
not possible because users don’t keep in contact with the most part of their sexual 
partners. From our center we are going to facilitate to get a test in all suspicious 
cases of contact to other cases.  
Our team has been trained during years in the use of rapid tests, including HIV 
ELISA, PCR, and Syphilis rapid tests. In this cases HCV viral load could be 
performed at the same time, but also HCV serology could be sent to the lab, as 
BCN Checkpoint disposes of nurses and doctors at all opening hours (from 8.00 to 
20.00 hours) to perform common blood test through standard venipuncture. 
 
Migrants or undocumented population could have difficulties in their access to the 
required HCV treatment. In case of confirmation of active HCV and no possibilities 
of treatment, our center has the possibility to facilitate fast access to the Public 
Health system to facilitate access to care and treatment, as it is considered a 
Health priority to eradicate HCV by 2030 in the context of WHO’s Global Health 
Sector Strategy on Viral Hepatitis program. This circuit has been used for HIV 
confirmed cases and the Public Health Agency is aware of this study and this 
possibility.  

 
 
 
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11.5. Expected Outcome 
It is expected that HCV screening has a good acceptance in the community. It is 
also expected to be easy to implement both the HCV test and HCV viral load as the 
center is used to this kind of tests.  
 
According to the 4.7% prevalence in the MSM community estimated by the ECDC 
for 2018, it is expected to find 305 positive cases of seroprevalence of HCV 
infection, but it unknow how many of them will be viremic, as HCV has actively 
been treated with DAAs in Spain. Therefore, it will be difficult to determinate 
number of acute HCV infection cases to be found if HCV viral load screening is 
performed. Also, in our cohort this number might be influenced by the fact that the 
center attends a migrant community with higher rates of HCV as well as more 
frequent Chemsex users.  
 
All these facts make it difficult to estimate the potential number of acute HCV 
cases, but we expect to find 10-15 cases of acute infections.  
 
Implementing HCV screening among the MSM community will increase the 
detection of acute cases and, due to higher infectiousness, we can contribute to 
increase the reduction of the transmission chain among the MSM community. 
Creating a model that could be implemented in other community centers like BCN 
Checkpoint will increase HCV detection and treatment, working in line with the 
WHO 2030 objectives of HCV eradication.  
 
It is also expected that acute HCV detections and partner notification create more 
awareness around MSM about the importance of HCV prevention.   

 
 
 
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Appendix 1. Informed Consent 
Attached separately in an independently versioned document. 
 
Appendix 2. Sexual behaviors and demographics questionnaire 
Attached separately in an independently versioned document. 
 

 
 
 
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Appendix 3. Satisfaction questionnaire PROMs  (SUCE Adaptation) 
1. El tiempo que pasó desde que pidió la cita hasta la fecha de consulta 1
1
2
3
4
5
6
7
8
9
10
2. Los trámites que tuvo que hacer en recepción
1
2
3
4
5
6
7
8
9
10
3. El tiempo de espera hasta ser atendido
1
2
3
4
5
6
7
8
9
10
4. La comodidad de la sala de espera
1
2
3
4
5
6
7
8
9
10
5. El trato por parte del personal 
1
2
3
4
5
6
7
8
9
10
6. El cuidado con su intimidad durante la consulta
1
2
3
4
5
6
7
8
9
10
7. La duración de la consulta
1
2
3
4
5
6
7
8
9
10
8. La información clínica recibida 
1
2
3
4
5
6
7
8
9
10
10. La claridad con que le explicaron las pruebas realizadas
1
2
3
4
5
6
7
8
9
10
11. La facilidad de los trámites que ha tenido que hacer si ha necesitado volver a citarse
1
2
3
4
5
6
7
8
9
10
Por favor puntúe de 1 a 10 las siguientes preguntas, siendo el 10 la respuesta mejor valorada y el 1 la respuesta peor valorada
Cuestionario de Satisfacción del Usuario

 
 
 
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Appendix 4. Bibliography 
 
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ii Mastroianni CM et al. Int J Mol Sci. 2014;15: 9184–9208 
iii Braun D et al. 25th CROI 2018; abstract LB87 
iv Boerekamp A et al. (4) 24th CROI 2017, abstract 136 
v Boerekamp A et al. (4) 24th CROI 2017, abstract 137LB 
vi Boerekamps A et al. High Treatment Uptake in Human Immunodeficiency Virus/Hepatitis C Virus-
Coinfected Patients After Unrestricted Access to Direct-Acting Antivirals in the Netherlands.  Clin Infect 
Dis. 2017 Nov 23.  
vii. Ingiliz P, et al. HCV reinfection incidence and spontaneous clearance rates in HIV-positive men who 
have sex with men in Western Europe. J Hepatol. 2017 Feb;66(2):282-287 
viii Cotte L et al. 25th CROI 2018, abstract 590 
ix Gras J et al. 25th CROI 2018, abstract 585 
x Gonzalez-Serna A, Macias J, Palacios R, Gómez-Ayerbe C, Tellez F, Rivero-Juárez A, Fernandez M, 
Santos J, Real LM, Gonzalez-Domenech CM, Gomez-Mateos J, Pineda JA; HEPAVIR study group. 
Incidence of recently acquired hepatitis C virus infection among HIV-infected patients in southern Spain. 
HIV Med. 2020 Dec 26. doi: 10.1111/hiv.13039. Epub ahead of print. PMID: 33369104 
xi Boesecke C et al. 25th CROI 2018, abstract 129 
xii Granado de la Orden S, et al.  Design and validation of a questionnaire of the hospital outpatient 
clinics in Madrid, Spain, 2006. Rev Esp Salud Publica. 2007 Nov-Dec;81(6):637-45. 
xiii Bernadien M Nijmeijer et al. Sexually transmitted hepatitis C virus infections: current trends, and 
recent advances in understanding the spread in men who have sex with men.  J Int AIDS Soc. 2019 Aug; 
22(Suppl Suppl 6): e25348. 
xiv Van De Laar TJW, et al. Sexual transmission of hepatitis C virus in human immunodeficiency 
virus‐negative men who have sex with men: a series of case reports. Sex Transm Dis. 2011;38(2):102–
104.  
xv Hagan H, Jordan AE, Neurer J, Cleland CM. Incidence of sexually transmitted hepatitis C virus infection 
in HIV‐positive men who have sex with men. AIDS. 2015;29(17):2335–2345. 
xvi Ghisla V, Scherrer AU, Nicca D, Braun DL, Fehr JS. Incidence of hepatitis C in HIV positive and negative 
men who have sex with men 2000–2016: a systematic review and meta‐analysis. Infection. 
2017;45(3):309–321. 
xvii Schmidt AJ, Rockstroh JK, Vogel M, An der Heiden M, Baillot A, Krznaric I, et al. Trouble with bleeding: 
risk factors for acute hepatitis C among HIV‐positive gay men from Germany‐A case‐control study. PLoS 
One. 2011;6(3):28–32. 
xviii Witt MD, Seaberg EC, Darilay A, Young S, Badri S, Rinaldo CR, et al. Incident hepatitis C virus infection 
in men who have sex with men: a prospective cohort analysis, 1984–2011. Clin Infect Dis. 
2013;57(1):77–84. 
xix Danta M, Brown D, Bhagani S, Pybus OG, Sabin CA, Nelson M, et al. Recent epidemic of acute hepatitis 
C virus in HIV‐positive men who have sex with men linked to high‐risk sexual behaviours. AIDS. 
2007;21(8):983–991. 
xx van Hommerig JW, Lambers FAE, Schinkel J, Geskus RB, Arends JE, van der Laar TJ, et al. Risk factors 
for sexual transmission of Hepatitis C virus among human immunodeficiency virus‐infected men who 
have sex with men: a case‐control study. Open Forum Infect Dis. 2015;2:1–8. 
xxi Hoornenborg E, et al. MSM starting preexposure prophylaxis are at risk of hepatitis C virus infection. 
AIDS. 2017 Jul 17;31(11):1603-1610. 
xxii Volk JE, et al. Incident hepatitis C virus infections among users of HIV preexposure prophylaxis in a 
clinical practice setting. Clin Infect Dis. 2015;60(11):1728–1729. 
xxiii McFaul K, et al. Acute hepatitis C infection in HIV‐negative men who have sex with men. J Viral Hepat. 
2015;22(6):535–538. 
xxiv Martinello M, et al. HCV reinfection incidence among individuals treated for recent infection. J Viral 
Hepat. 2018;24(5):359–370.